Updated: 22nd September 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder and CEO)
Understanding the Role of Notified Bodies
A Notified Body is an independent conformity assessment organisation designated by an EU Member State to assess whether certain medical devices and in vitro diagnostic medical devices meet the applicable requirements of the EU Medical Device Regulation (EU) 2017/745 (MDR) or the EU In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR).
For many devices, manufacturers cannot place the CE mark on the product solely on the basis of self-declaration. Instead, an appropriately designated Notified Body must assess relevant elements of the manufacturer’s quality management system, technical documentation, clinical or performance evidence, risk management and post-market arrangements before certification can be issued.
The extent of Notified Body involvement depends on factors including:
- the classification of the device;
- whether the product is a medical device or IVD;
- the conformity assessment route selected;
- the technology and intended purpose of the device; and
- the designation scope of the chosen Notified Body.
Notified Bodies therefore act as an important independent checkpoint within the European regulatory system. Their role is not to design the device or prepare the manufacturer’s regulatory documentation, but to independently assess whether the manufacturer has demonstrated conformity with the applicable regulatory requirements.
Why Notified Body involvement matters
Where Notified Body assessment is required, successful certification is a key step towards CE marking and access to the EU market. Manufacturers must therefore ensure that their regulatory strategy, technical documentation and quality management system are sufficiently mature before entering the conformity assessment process.
Preparation is particularly important because deficiencies identified during assessment can result in additional questions, corrective actions, further evidence requests and delays to certification.
Need an Introduction to the EU MDR?
This article explains the role of Notified Bodies under the EU MDR and IVDR. If you're looking for a complete overview of the Medical Device Regulation, including classification, GSPRs, Technical Documentation, UDI, EUDAMED, CE marking and post-market obligations, read our Complete Guide to the EU MDR.
Working with In Vitro Diagnostic Devices?
Notified Bodies also play a critical role under the In Vitro Diagnostic Medical Devices Regulation (IVDR). If you're looking for a complete guide to IVDR classification, performance evaluation, Technical Documentation, conformity assessment and CE marking, read our Complete Guide to the EU IVDR.
When Is a Notified Body Required?
Not every medical device requires assessment by a Notified Body before it can be CE marked. The level of third-party involvement depends primarily on the device classification and the applicable conformity assessment route under the MDR or IVDR.
Medical Devices Under the EU MDR
Under the EU MDR 2017/745, most devices above Class I require involvement of a suitably designated Notified Body.
Class I medical devices can generally be self-declared by the manufacturer, meaning that a Notified Body is not required. However, there are important exceptions:
- Class Is – sterile devices require Notified Body involvement for aspects relating to establishing, securing and maintaining sterile conditions.
- Class Im – devices with a measuring function require Notified Body involvement for aspects relating to conformity with metrological requirements.
- Class Ir – reusable surgical instruments require Notified Body involvement for aspects relating to device reuse, particularly cleaning, disinfection, sterilisation, maintenance and functional testing.
For Class IIa, Class IIb and Class III medical devices, Notified Body involvement is required as part of the applicable conformity assessment procedure.
The level and depth of assessment generally increase according to the regulatory risk associated with the device. Higher-risk devices can therefore be subject to more extensive assessment of the manufacturer’s quality management system, technical documentation and clinical evidence.
In Vitro Diagnostic Devices Under the EU IVDR
The EU IVDR 2017/746 introduced significantly greater Notified Body involvement than existed under the previous IVD Directive.
IVDs are classified as Class A, B, C or D, according to the classification rules contained within Annex VIII of the IVDR.
Most Class A IVDs can be self-declared without Notified Body involvement. However, for Class A devices placed on the market in a sterile condition, Notified Body involvement is required for the aspects relating to establishing, securing and maintaining sterile conditions.
For Class B, Class C and Class D IVDs, conformity assessment requires involvement of an appropriately designated Notified Body.
This means manufacturers transitioning from the former IVD Directive to the IVDR may now require Notified Body assessment even where their devices were previously self-declared.
The Notified Body Must Have the Correct Scope
Manufacturers cannot simply select any organisation appearing on the list of European Notified Bodies.
The chosen Notified Body must be designated under the applicable Regulation and for the appropriate scope of devices and conformity assessment activities relevant to the manufacturer’s product.
Designation information can be checked through the European Commission’s NANDO (New Approach Notified and Designated Organisations) Information System.
This makes checking a prospective Notified Body’s designation scope an important early step in developing an MDR or IVDR conformity assessment strategy.
Notified Body vs Competent Authority vs Authorised Representative
Although each plays an important role within the European medical device regulatory framework, Notified Bodies, Competent Authorities and EU Authorised Representatives have different responsibilities.
Understanding these distinctions is particularly important for manufacturers located outside the European Union.
Notified Body
A Notified Body is an independent conformity assessment organisation designated to perform specific assessment activities under the MDR or IVDR.
Depending on the applicable conformity assessment route, its activities may include reviewing:
- the manufacturer’s quality management system;
- technical documentation;
- clinical evaluation or performance evaluation;
- risk management documentation;
- verification and validation evidence;
- post-market surveillance and PMCF or PMPF arrangements; and
- continued compliance through surveillance activities.
Where required, successful conformity assessment can result in the Notified Body issuing the relevant certificate needed to support CE marking.
Competent Authority
A Competent Authority is the government authority responsible for overseeing implementation and enforcement of medical device legislation within an EU Member State.
Its responsibilities can include market surveillance, vigilance, regulatory enforcement and oversight of economic operators and Notified Bodies within its jurisdiction.
Competent Authorities therefore perform a regulatory oversight role rather than providing commercial conformity assessment services to manufacturers.
EU Authorised Representative
Manufacturers established outside the European Union must appoint a sole EU Authorised Representative for devices placed on the EU market, in accordance with the MDR or IVDR.
The Authorised Representative acts on behalf of the manufacturer in relation to specified regulatory obligations and provides an established point of contact within the European Union.
Its responsibilities include activities such as verifying that required regulatory documentation and conformity assessment have been completed, maintaining access to specified documentation and cooperating with Competent Authorities.
An EU Authorised Representative does not replace a Notified Body. Where the device requires third-party conformity assessment, the manufacturer may need both an appropriately designated Notified Body and an EU Authorised Representative.
Are You a Non-EU Medical Device Manufacturer?
Manufacturers established outside the European Union must appoint an EU Authorised Representative before placing devices on the EU market. Learn about the role, responsibilities and requirements of an EU AR in our Complete Guide to EU Authorised Representatives for Medical Devices.
How Are Notified Bodies Designated?
An organisation cannot operate as a Notified Body under the MDR or IVDR simply because it has experience in medical device certification. It must undergo a formal designation and notification process demonstrating that it meets the applicable regulatory requirements.
Under the MDR and IVDR, candidate organisations are assessed by the relevant national authority together with representatives involved in the European joint assessment process. The assessment considers areas such as the organisation’s independence, impartiality, competence, resources, procedures and technical expertise.
Once successfully designated, the organisation is notified to the European Commission and the other Member States and is assigned a four-digit Notified Body identification number.
What Is NANDO?
The European Commission maintains the NANDO (New Approach Notified and Designated Organisations) Information System, which provides official information about organisations notified under EU product legislation.
For medical device manufacturers, NANDO is an important resource because it can be used to check:
- whether an organisation is currently designated;
- whether it is designated under the MDR, IVDR or both;
- its Notified Body identification number;
- the device categories covered by its designation;
- the conformity assessment procedures it is authorised to perform; and
- any limitations applying to its designation.
Why the Notified Body's Scope Matters
Being designated under the MDR or IVDR does not automatically mean that a Notified Body can assess every type of medical device or IVD.
Each Notified Body has a defined designation scope covering particular device categories, technologies and conformity assessment activities.
Manufacturers should therefore verify that a prospective Notified Body’s designation covers their particular device before progressing with an application.
This is especially important for devices involving specialised technologies or higher-risk characteristics, where the number of suitably designated Notified Bodies may be more limited.
Always Check the Current NANDO Listing
Notified Body designations and scopes can change over time. Manufacturers should therefore use the current NANDO database rather than relying solely on historic certification experience, third-party lists or assumptions based on an organisation’s previous designation under the former Medical Device Directives.
How to Choose the Right Notified Body
Choosing a Notified Body is an important strategic decision. Although all Notified Bodies operate within the same regulatory framework, their designation scope, technical expertise, capacity, application processes and commercial arrangements can differ.
Manufacturers should therefore consider more than availability or cost when selecting a Notified Body.
1. Confirm the Designation Scope
The first step is to confirm through NANDO that the Notified Body is designated under the applicable Regulation and has the appropriate scope for the device concerned.
Manufacturers should consider the device’s:
- intended purpose;
- classification;
- technology;
- applicable MDR or IVDR codes;
- specific characteristics, such as sterility or measuring functions; and
- proposed conformity assessment route.
Where there is uncertainty, the manufacturer should discuss the device and proposed scope directly with the prospective Notified Body.
2. Consider Relevant Technical Expertise
A Notified Body should have access to appropriate expertise for the technologies and clinical areas relevant to the device.
This becomes particularly important for innovative, complex or higher-risk devices where assessment may require specialist knowledge of areas such as software, cybersecurity, biological safety, sterilisation, clinical evidence or performance evaluation.
3. Consider Capacity and Timescales
Notified Body capacity has been an important consideration since implementation of the MDR and IVDR.
Manufacturers should establish expected timescales for:
- application and initial review;
- contract and quotation;
- quality management system assessment;
- technical documentation assessment;
- responding to nonconformities or questions; and
- certification following successful completion of assessment.
These timescales should be incorporated into the manufacturer’s overall regulatory and commercial planning.
4. Understand the Application and Assessment Process
Before entering into an agreement, manufacturers should understand how the Notified Body manages applications and conformity assessment.
This can include how technical documentation is submitted, how communication is managed, whether particular templates or submission structures are expected, and how findings and requests for additional information are handled.
5. Consider Ongoing Certification Requirements
The relationship with a Notified Body does not normally end when the initial certificate is issued.
Depending on the conformity assessment route and device, manufacturers may subsequently undergo activities including surveillance audits, technical documentation sampling or review, assessment of certain changes and recertification.
It is therefore sensible to consider the longer-term working relationship rather than viewing Notified Body selection solely as a route to initial CE certification.
Preparing Before You Apply
Manufacturers do not necessarily need every aspect of the conformity assessment process completed before first contacting a Notified Body. However, approaching the process with a clear regulatory strategy and sufficiently developed documentation can reduce avoidable delays later.
Before formal assessment, manufacturers should have a clear understanding of their device classification, applicable conformity assessment route, quality management system requirements, technical documentation, clinical or performance evidence and post-market obligations.
The MDR and IVDR Conformity Assessment Process
Where Notified Body involvement is required, manufacturers must complete an appropriate conformity assessment procedure before the device can be CE marked and placed on the EU market.
The precise route depends on the device classification, type of device and applicable requirements of the MDR or IVDR. However, the process will generally involve the following stages.
1. Determine the Device Classification
The manufacturer must first establish the correct classification of the device.
For medical devices, classification is determined using the rules in Annex VIII of the MDR, resulting in Class I, IIa, IIb or III.
For IVDs, the classification rules in Annex VIII of the IVDR result in Class A, B, C or D.
Classification is important because it determines the level of regulatory scrutiny and the conformity assessment routes available to the manufacturer.
Need Help Understanding EU Medical Device Classification?
Device classification determines the level of regulatory scrutiny and the conformity assessment route available under the EU MDR. For a practical explanation of Classes I, IIa, IIb and III, including the Annex VIII classification rules, read our Complete Guide to EU Medical Device Classification.
2. Select the Conformity Assessment Route
The manufacturer must identify an appropriate conformity assessment procedure permitted for its device.
Under the MDR, the principal routes involving a Notified Body are set out in:
- Annex IX – Conformity assessment based on a quality management system and assessment of technical documentation;
- Annex X – Conformity assessment based on type examination; and
- Annex XI – Conformity assessment based on product conformity verification.
The IVDR contains corresponding conformity assessment procedures within Annex IX, Annex X and Annex XI.
The appropriate route depends on the device and its classification, and manufacturers should establish their intended conformity assessment strategy early in the regulatory process.
3. Establish the Quality Management System
Where required by the chosen conformity assessment route, the manufacturer must establish and maintain an appropriate Quality Management System (QMS).
For many manufacturers, this is developed around EN ISO 13485, although compliance with ISO 13485 alone does not demonstrate compliance with every requirement of the MDR or IVDR.
The QMS must incorporate the applicable regulatory requirements across areas including design and development, supplier controls, production, risk management, clinical or performance evaluation, post-market surveillance, vigilance and regulatory reporting.
Building a Medical Device Quality Management System?
ISO 13485 provides the internationally recognised framework for medical device quality management systems. Learn about its requirements, regulatory role and how it supports medical device compliance in our Complete Guide to ISO 13485.
4. Prepare the Technical Documentation
The manufacturer must compile technical documentation demonstrating that the device meets the applicable requirements of the Regulation.
Depending on the product, this can include:
- device description and specification;
- intended purpose and classification rationale;
- design and manufacturing information;
- General Safety and Performance Requirements;
- risk management documentation;
- verification and validation evidence;
- biological safety, where applicable;
- software verification and validation, where applicable;
- clinical evaluation or performance evaluation;
- labelling and Instructions for Use;
- post-market surveillance documentation; and
- PMCF or PMPF documentation, where applicable.
Preparing Your Medical Device Technical File?
Technical Documentation provides the evidence that a medical device meets the applicable regulatory requirements. For a practical breakdown of the documents, evidence and structure expected under the EU MDR, read our Guide to Structuring a Medical Device Technical File.
5. Apply to a Notified Body
The manufacturer submits an application to a suitably designated Notified Body.
The Notified Body will establish whether the device falls within its designation scope and whether it can accept the application before progressing into the formal conformity assessment process.
Manufacturers should provide complete and consistent information about the device and proposed certification scope, as discrepancies at this stage can cause delays later in the assessment.
6. Quality Management System and Technical Documentation Assessment
Depending on the applicable route, the Notified Body may assess both the manufacturer’s QMS and the technical documentation for the device.
This can involve a combination of documentation review and on-site or otherwise permitted audit activities.
The Notified Body may raise nonconformities, observations or requests for additional information where the evidence supplied does not adequately demonstrate conformity.
The manufacturer must respond to these findings and provide appropriate corrections, corrective actions or additional evidence.
7. Certification and CE Marking
Where the conformity assessment is successfully completed, the Notified Body issues the applicable certificate or certificates.
The manufacturer must then complete the remaining regulatory requirements applicable to the device, including preparing the EU Declaration of Conformity.
Where Notified Body involvement is required, the CE marking is accompanied by the four-digit identification number of the Notified Body responsible for the applicable conformity assessment activities.
8. Ongoing Surveillance
Certification is not the end of the regulatory process.
Manufacturers must continue to maintain conformity throughout the device lifecycle. Depending on the certification route and device, the Notified Body’s ongoing activities can include:
- surveillance audits;
- assessment of continued QMS compliance;
- technical documentation assessment or sampling;
- review of relevant post-market information;
- assessment of certain proposed changes;
- unannounced audits where applicable; and
- recertification before certificate expiry.
This ongoing oversight makes post-market surveillance, vigilance, PMCF/PMPF and effective change control important parts of maintaining certification.
What Happens After Your Device Reaches the Market?
Post-market surveillance is a continuous regulatory obligation throughout the medical device lifecycle. Learn how manufacturers collect and evaluate post-market data, manage PMS plans and reports, identify emerging risks and maintain ongoing compliance in our Complete Guide to Medical Device Post-Market Surveillance.
Understanding Annex IX, Annex X and Annex XI
The MDR and IVDR provide different conformity assessment procedures depending on the classification and characteristics of the device. Manufacturers must select a route permitted for their device and demonstrate conformity using the requirements associated with that procedure.
The three principal routes involving a Notified Body are contained within Annex IX, Annex X and Annex XI.
Annex IX – Quality Management System and Technical Documentation Assessment
Annex IX provides a conformity assessment route based on the manufacturer’s quality management system together with assessment of the relevant technical documentation.
Under this route, the Notified Body assesses whether the manufacturer’s QMS is capable of ensuring that devices consistently comply with the applicable regulatory requirements.
The assessment can include areas such as:
- regulatory strategy and compliance procedures;
- design and development controls;
- risk management;
- manufacturing and supplier controls;
- clinical or performance evaluation;
- verification and validation;
- post-market surveillance;
- vigilance;
- PMCF or PMPF; and
- processes for maintaining regulatory compliance throughout the device lifecycle.
The Notified Body also assesses technical documentation in accordance with the requirements applicable to the device and its classification.
For many manufacturers, Annex IX provides an integrated approach covering both the quality system and device documentation.
Annex X – EU Type Examination
Annex X provides a conformity assessment procedure based on EU type examination.
Under this route, the Notified Body examines the technical documentation and supporting evidence for a representative device or product type to verify that it meets the applicable requirements of the MDR or IVDR.
Where conformity is demonstrated, the Notified Body can issue an EU Type-Examination Certificate.
However, type examination alone does not complete the conformity assessment. It must be combined with an appropriate procedure for demonstrating that devices subsequently manufactured conform to the approved type.
Annex XI – Product Conformity Verification
Annex XI focuses on demonstrating that manufactured devices conform to the type for which an EU Type-Examination Certificate has been issued, where that combination of procedures is used.
Depending on the applicable route, this can involve either:
Production Quality Assurance – where the Notified Body assesses and monitors the manufacturer’s quality system relating to production and final inspection; or
Product Verification – where conformity of manufactured devices is verified through examination and testing in accordance with the applicable regulatory requirements.
Annex XI is therefore generally used alongside Annex X EU type examination, rather than as a standalone alternative covering the complete conformity assessment process.
Which Conformity Assessment Route Should a Manufacturer Use?
There is no single conformity assessment route that applies to every medical device or IVD.
The routes available depend on factors including the device classification, device characteristics and applicable provisions of the MDR or IVDR.
Manufacturers should determine their intended conformity assessment strategy early, because the selected route can influence the structure of the QMS, interaction with the Notified Body and evidence required for certification.
What Does a Notified Body Review?
A Notified Body assessment is not limited to checking whether the correct documents exist. The assessment considers whether the manufacturer has provided sufficient objective evidence to demonstrate conformity with the applicable requirements of the MDR or IVDR.
The exact depth and scope of assessment depend on the device, its classification and the conformity assessment route, but several areas commonly form part of the review.
Quality Management System
Where applicable, the Notified Body assesses the manufacturer’s Quality Management System (QMS) and its implementation.
This can include processes covering:
- regulatory compliance;
- design and development;
- document and record control;
- supplier and purchasing controls;
- production and process controls;
- verification and validation;
- risk management;
- complaint handling;
- vigilance;
- post-market surveillance;
- corrective and preventive action (CAPA); and
- change control.
The assessment is not simply an ISO 13485 certification exercise. The manufacturer must also demonstrate that the QMS incorporates the applicable requirements of the MDR or IVDR.
Technical Documentation
The Notified Body may review the manufacturer’s Technical Documentation to determine whether the device has been adequately documented and whether the evidence supports conformity with the applicable General Safety and Performance Requirements (GSPRs).
The review can cover the device description, intended purpose, classification, design and manufacturing information, labelling, verification and validation evidence and supporting regulatory documentation.
Importantly, the different elements of the Technical Documentation should be consistent with one another. For example, the intended purpose, risk management documentation, clinical evidence, labelling and post-market strategy should describe and support the same device and claims.
Risk Management
Manufacturers must establish and maintain a systematic risk management process throughout the device lifecycle.
Notified Body assessment can therefore consider whether hazards have been appropriately identified, risks estimated and evaluated, suitable risk controls implemented and residual risks assessed.
The risk management documentation should also align with other evidence within the Technical Documentation, including verification and validation, clinical evaluation, usability, biological safety and post-market information.
Clinical Evaluation and Performance Evaluation
For medical devices, the Notified Body may assess the manufacturer’s Clinical Evaluation to determine whether sufficient clinical evidence supports the device’s intended purpose, safety, performance and claimed clinical benefits.
For IVDs, the corresponding Performance Evaluation considers scientific validity, analytical performance and clinical performance, as applicable.
The level of evidence required depends on the device and its regulatory characteristics. Higher-risk, novel or clinically significant technologies can require particularly robust evidence.
Preparing Your Medical Device Clinical Evaluation?
Clinical evaluation is a core part of demonstrating the safety, performance and clinical benefit of a medical device under the EU MDR. Learn about Clinical Evaluation Plans, clinical data, literature reviews, equivalence, Clinical Evaluation Reports and ongoing updates in our Complete Guide to Medical Device Clinical Evaluation.
Preparing an IVDR Performance Evaluation?
Performance evaluation is central to demonstrating that an IVD is safe and performs as intended under the EU IVDR. Learn how scientific validity, analytical performance and clinical performance come together within the Performance Evaluation Plan and Report in our Complete Guide to IVDR Performance Evaluation.
Verification and Validation
The Notified Body can assess whether the manufacturer has adequately demonstrated that the device meets its design requirements and performs as intended.
Depending on the device, this may include evidence relating to:
- electrical safety and electromagnetic compatibility;
- software verification and validation;
- cybersecurity;
- usability engineering;
- sterilisation;
- cleaning and disinfection;
- packaging;
- shelf life and stability;
- mechanical or functional performance; and
- other device-specific testing.
Testing should be appropriately planned, justified and linked to the risks and performance requirements of the device.
Planning Medical Device Verification and Validation?
Verification and validation provide essential evidence that a medical device meets its specified requirements and performs safely as intended. Explore testing strategies, regulatory expectations and key areas including software, usability, cleaning, sterilisation and packaging in our Complete Guide to Medical Device Validation.
Biological Evaluation
For devices involving direct or indirect contact with the human body, the Notified Body may review the manufacturer’s biological evaluation and supporting biocompatibility evidence.
The biological evaluation should consider the nature and duration of contact, materials, manufacturing processes, available information and identified biological risks.
Testing should not simply be performed as a standard checklist. The overall evaluation should provide a scientifically justified assessment of biological safety based on the characteristics and risks of the particular device.
Preparing a Biological Evaluation for Your Medical Device?
Biological evaluation is an important part of demonstrating the safety of medical devices that have direct or indirect contact with the human body. Learn how ISO 10993-1, biological risk assessment, material characterisation, toxicological evaluation and biocompatibility testing fit together in our Complete Guide to Biological Evaluation of Medical Devices.
Post-Market Surveillance and PMCF/PMPF
Manufacturers must demonstrate how they will continue to monitor the safety and performance of their devices once they are placed on the market.
The Notified Body may therefore review documentation relating to:
- Post-Market Surveillance (PMS);
- Post-Market Clinical Follow-up (PMCF);
- Post-Market Performance Follow-up (PMPF) for IVDs;
- vigilance and incident reporting;
- trend reporting;
- Periodic Safety Update Reports (PSURs), where applicable; and
- processes for feeding post-market information back into risk management, clinical or performance evaluation and other regulatory documentation.
This lifecycle approach is important because conformity must be maintained after certification, rather than demonstrated only at the point the device first receives its CE marking.
What Happens During a Notified Body Audit?
Where the conformity assessment route includes assessment of the manufacturer’s quality management system, the Notified Body will audit the organisation to determine whether its documented processes are appropriately implemented, maintained and effective in practice.
The audit is therefore more than a review of procedures. Manufacturers should be prepared to demonstrate how their QMS operates using objective evidence such as records, completed forms, design documentation, supplier evaluations, training records, CAPAs and post-market data.
Preparing for the Audit
Before the audit, the manufacturer should ensure that its QMS and regulatory documentation are sufficiently mature and that personnel understand their responsibilities.
Preparation should include reviewing:
- the scope of certification;
- QMS procedures and records;
- organisational responsibilities;
- device Technical Documentation;
- design and development records;
- risk management documentation;
- supplier controls;
- production and process controls;
- verification and validation evidence;
- clinical or performance evaluation;
- complaint and vigilance processes;
- PMS and PMCF/PMPF activities;
- CAPA records; and
- previous audit findings, where applicable.
Documentation should also be internally consistent and readily accessible during the assessment.
During the Audit
During an audit, the Notified Body’s audit team may interview personnel, review procedures and records, examine evidence of implementation and follow processes through different areas of the organisation.
Rather than assessing individual procedures in isolation, auditors may follow an audit trail across connected processes.
For example, an auditor could select a design change and examine how it was:
requested → risk assessed → reviewed → verified or validated → approved → documented → reflected in the Technical Documentation → considered for regulatory impact.
This makes effective document control, traceability and change management particularly important.
Notified Body Nonconformities
Where the auditor identifies that regulatory or QMS requirements have not been adequately fulfilled, a nonconformity may be raised.
The manufacturer will normally need to investigate the issue, determine its cause and establish appropriate corrections and corrective actions.
Depending on the nature of the finding, the response may need to include:
- correction of the immediate issue;
- root cause analysis;
- corrective action;
- assessment of whether similar issues exist elsewhere;
- supporting implementation evidence; and
- verification that the corrective action is effective.
The Notified Body will assess the manufacturer’s response before determining whether the finding can be closed.
Surveillance and Recertification Audits
Notified Body audits continue after initial certification.
Manufacturers can expect periodic surveillance activities to confirm that the approved QMS continues to operate effectively and that regulatory requirements remain fulfilled.
The Notified Body may also perform unannounced audits, where applicable, and certification must undergo reassessment before the relevant certificate expires.
Manufacturers should therefore maintain a state of ongoing regulatory readiness rather than treating the Notified Body audit as a one-off certification exercise.
Want to Understand the Notified Body’s Role in Certification?
Notified Bodies play an important role throughout medical device conformity assessment and ongoing certification. Explore how they assess manufacturers, review regulatory evidence and support the CE marking process in our Guide to the Role of Notified Bodies in Medical Device Certification.
Common Notified Body Findings and How to Avoid Them
Notified Body findings can arise when the evidence presented by a manufacturer is incomplete, inconsistent or does not adequately demonstrate conformity with the MDR or IVDR.
Although findings will depend on the device and assessment, several areas commonly require particular attention.
Inconsistencies Across Technical Documentation
One of the most avoidable problems is inconsistency between different parts of the Technical Documentation.
The intended purpose, indications, contraindications, claims, device description and patient population should be consistently reflected across documents such as:
- labelling and Instructions for Use;
- risk management documentation;
- Clinical Evaluation or Performance Evaluation;
- verification and validation;
- usability documentation;
- PMS and PMCF/PMPF documentation; and
- the Declaration of Conformity.
Changes made to one document should therefore be assessed for their impact on the wider Technical Documentation.
Weak or Incomplete Clinical Evidence
Clinical evidence must be sufficient to support the device’s intended purpose, safety, performance and clinical benefits.
Potential weaknesses can include inadequate literature searches, unsupported claims, insufficient appraisal of clinical data, poorly justified equivalence or failure to demonstrate how clinical evidence relates to identified risks and claimed benefits.
The Clinical Evaluation should also remain a living process, incorporating relevant information generated through post-market activities.
Risk Management Not Linked to Other Evidence
Risk management should not exist as a standalone document.
Identified risks and risk control measures should be traceable to relevant evidence, including design requirements, verification and validation, usability engineering, biological evaluation, clinical evidence, labelling and post-market surveillance.
Where a risk control depends upon a warning, design feature or particular test, the manufacturer should be able to demonstrate that connection.
Inadequate Verification and Validation
Manufacturers should ensure that testing is appropriate to the device and supports the relevant design requirements and regulatory claims.
Common weaknesses can include incomplete test coverage, inappropriate test methods, insufficient justification for sample sizes, missing acceptance criteria or inadequate justification where testing has not been performed.
Where recognised standards are used, manufacturers should also ensure that the applicable versions and relevant requirements have been correctly considered.
Weak Post-Market Surveillance
PMS documentation should explain how information will be actively and systematically collected, analysed and used.
A PMS plan that merely states that complaints will be reviewed is unlikely to demonstrate a comprehensive post-market system.
Manufacturers should consider appropriate sources of information and clearly establish how findings feed back into areas such as risk management, clinical evaluation, benefit-risk assessment and corrective action.
Poor QMS Implementation
Having well-written procedures is not sufficient if there is little evidence that they are being followed.
During an audit, a Notified Body may look for objective evidence that procedures have actually been implemented, including:
- training records;
- supplier evaluations;
- design reviews;
- CAPA records;
- internal audits;
- management reviews;
- complaint investigations;
- change controls; and
- completed PMS activities.
Manufacturers should therefore focus on both documenting their processes and demonstrating their effective implementation.
Insufficient Change Control
Changes to a device, its intended purpose, manufacturing processes, suppliers, software, materials, labelling or QMS can have wider regulatory consequences.
An effective change-control process should consider whether a proposed change affects:
risk management → verification and validation → clinical evidence → Technical Documentation → labelling → post-market activities → regulatory approvals or certification.
Where required under the applicable conformity assessment arrangements, manufacturers should determine whether the change needs to be notified to or approved by their Notified Body before implementation.
Preparing for Notified Body Assessment
The most effective approach is to identify potential deficiencies before formal assessment begins.
Internal audits, Technical Documentation reviews and regulatory gap assessments can help manufacturers identify missing evidence, inconsistencies and weaknesses while there is still time to address them.
A well-prepared submission should tell a consistent regulatory story: the intended purpose drives classification and applicable requirements; risks drive appropriate controls; verification and validation demonstrate those controls are effective; clinical or performance evidence supports safety and performance; and post-market activities confirm that this evidence continues to remain valid throughout the device lifecycle.
Could Your Technical Documentation Withstand Notified Body Review?
Technical Documentation deficiencies can lead to additional questions, corrective actions and delays during conformity assessment. Learn about common MDR documentation weaknesses and how manufacturers can prepare more robust submissions in our Guide to Common MDR Technical Documentation Deficiencies.
How Long Does Notified Body Certification Take?
There is no single fixed timeframe for completing Notified Body conformity assessment under the MDR or IVDR. The duration depends on the device, the manufacturer, the quality of the submission and the capacity of the selected Notified Body.
Manufacturers should therefore build sufficient time into their regulatory strategy and avoid treating Notified Body assessment as a predictable administrative step immediately before product launch.
What Can Affect the Certification Timeline?
Several factors can influence how long conformity assessment takes, including:
- device classification and complexity;
- whether assessment is under the MDR or IVDR;
- the applicable conformity assessment route;
- the Notified Body’s designation scope and capacity;
- maturity of the manufacturer’s QMS;
- completeness and quality of the Technical Documentation;
- complexity of the clinical or performance evidence;
- whether specialist expertise is required;
- number and significance of findings raised during assessment; and
- how quickly the manufacturer responds to requests for additional information.
Higher-risk or novel devices may require more extensive assessment and potentially additional regulatory procedures.
Notified Body Availability
Manufacturers should engage with potential Notified Bodies early in the regulatory process.
Availability can vary between organisations and device scopes. A Notified Body may be appropriately designated for a device but may not have immediate capacity to accept a new application or begin assessment.
Early engagement allows the manufacturer to establish whether the organisation can assess the device and understand its application process, expected documentation and indicative availability.
Documentation Quality Can Affect the Timeline
Incomplete or inconsistent documentation can significantly extend conformity assessment.
If the Notified Body identifies deficiencies, it may issue questions, requests for additional information or nonconformities that the manufacturer must address before assessment can progress.
A well-prepared submission should therefore aim to ensure that the QMS, Technical Documentation, risk management, clinical or performance evidence, verification and validation and post-market documentation are complete and mutually consistent before formal assessment.
Plan Backwards From the Intended Market Date
Manufacturers should avoid assuming that submitting an application to a Notified Body means certification is imminent.
A regulatory project plan should allow time for:
Notified Body selection → application → contract and scheduling → QMS assessment → Technical Documentation assessment → questions and findings → manufacturer responses → closure of findings → certification → final CE marking activities.
Adequate contingency should also be included for unexpected findings or additional evidence requirements.
For manufacturers developing a new device, Notified Body planning should begin well before the intended commercial launch, rather than after product development and testing have already been completed.
What Happens After Notified Body Certification?
Receiving a Notified Body certificate is an important milestone, but it does not mark the end of the manufacturer’s regulatory responsibilities. Certification must be maintained throughout the device lifecycle, and the manufacturer must continue to demonstrate conformity with the MDR or IVDR.
The Notified Body will continue to perform oversight activities for as long as the relevant certification remains in place.
Ongoing Surveillance
Notified Bodies carry out surveillance activities to confirm that the manufacturer continues to comply with the approved quality management system and applicable regulatory requirements.
Depending on the certification and conformity assessment route, this may include:
- periodic surveillance audits;
- review of QMS records and implementation;
- technical documentation assessment or sampling, where applicable;
- review of relevant post-market information;
- follow-up of previous findings and corrective actions; and
- unannounced audits where applicable.
Manufacturers should therefore maintain their QMS and Technical Documentation in a state of continuous regulatory readiness.
Maintaining Technical Documentation
Technical Documentation should be maintained and updated throughout the lifecycle of the device.
Updates may be necessary following:
- design or manufacturing changes;
- changes to suppliers or materials;
- new verification or validation evidence;
- changes to standards or regulatory requirements;
- new clinical or performance information;
- complaints or vigilance data;
- PMS and PMCF/PMPF findings; or
- changes to labelling, intended purpose or device claims.
These updates should be appropriately controlled and assessed for their regulatory impact.
Changes to the Device or Quality Management System
Manufacturers should have an effective process for assessing proposed changes before implementation.
Depending on the nature of the change and the applicable certification arrangements, certain changes to the approved QMS or device covered by the certification may need to be reported to the Notified Body and assessed before they are implemented.
The manufacturer should therefore consider whether a proposed change affects areas such as:
intended purpose → design → risk management → clinical or performance evidence → verification and validation → manufacturing → labelling → post-market activities → certification.
Change-control procedures should also define how the need for Notified Body involvement is identified and documented.
Post-Market Evidence Feeds Back Into Certification
Information generated after the device reaches the market should be actively incorporated into the manufacturer’s regulatory system.
PMS, PMCF/PMPF, complaints, vigilance, trend data and other relevant information may result in updates to:
- risk management;
- Clinical Evaluation or Performance Evaluation;
- benefit-risk conclusions;
- Technical Documentation;
- labelling and Instructions for Use;
- CAPA activities; and
- product or process controls.
This creates a continuous lifecycle between pre-market evidence, certification and real-world post-market experience.
Certificate Renewal and Recertification
Notified Body certificates have a defined period of validity and cannot simply be assumed to continue indefinitely.
Before expiry, the manufacturer will need to complete the applicable recertification or renewal activities to demonstrate continued conformity.
Manufacturers should plan for this sufficiently early, ensuring that their QMS, Technical Documentation and post-market evidence remain current and that outstanding regulatory issues have been addressed.
Maintaining Compliance Is a Continuous Process
CE marking should therefore be viewed as the beginning of the commercial phase of regulatory compliance rather than the end of the regulatory project.
Successful manufacturers maintain systems that continuously connect:
QMS → Risk Management → Technical Documentation → Clinical/Performance Evidence → PMS → CAPA → Change Control → Continued Certification.
This lifecycle approach helps ensure that the device continues to meet the applicable requirements throughout its time on the European market.
Changing or Transferring to a Different Notified Body
A manufacturer may decide, or in some circumstances need, to change its Notified Body. This can occur for commercial or operational reasons, because of changes in designation scope or availability, or because the existing Notified Body can no longer provide the required conformity assessment activities.
Changing Notified Body requires careful regulatory planning. Manufacturers should not treat it as simply replacing one certification provider with another.
Why Might a Manufacturer Change Notified Body?
Reasons can include:
- changes to the Notified Body’s designation or scope;
- capacity or scheduling constraints;
- changes to the manufacturer’s device portfolio;
- commercial or contractual considerations;
- organisational restructuring;
- the need for different technical expertise; or
- withdrawal, suspension or cessation of relevant Notified Body activities.
Whatever the reason, continuity of valid certification and regulatory oversight must be carefully managed.
Transferring Certification
Where a manufacturer voluntarily changes Notified Body, Article 58 of the MDR and Article 53 of the IVDR establish requirements concerning the voluntary change of Notified Body.
A clearly defined agreement is required between the manufacturer, the incoming Notified Body and, where practicable, the outgoing Notified Body.
The agreement should address matters including:
- the date on which the outgoing Notified Body’s certificates become invalid;
- the date until which the outgoing Notified Body’s identification number may continue to appear on relevant information supplied by the manufacturer;
- transfer of relevant documentation;
- completion of outstanding assessment activities; and
- the date from which the incoming Notified Body assumes responsibility for conformity assessment activities.
Certificates and Notified Body Identification Numbers
Where Notified Body involvement is required, the CE marking is accompanied by the identification number of the Notified Body responsible for the applicable conformity assessment activities.
A change of Notified Body can therefore have implications for labelling, packaging and other information identifying the Notified Body.
Manufacturers should establish an appropriate transition plan and ensure that use of the outgoing and incoming Notified Body identification numbers follows the agreed regulatory arrangements.
Plan the Transition Carefully
Before initiating a transfer, manufacturers should consider the status of:
- existing certificates;
- upcoming surveillance or recertification activities;
- open nonconformities;
- Technical Documentation reviews;
- outstanding corrective actions;
- device and QMS changes;
- current production and inventory;
- labelling and packaging; and
- planned market introductions.
The incoming Notified Body may also need to review existing certification information and determine what additional assessment is necessary before assuming responsibility.
What if the Notified Body Ceases Its Activities?
A different situation arises where a Notified Body ceases its conformity assessment activities or loses the ability to perform them.
The MDR and IVDR contain provisions addressing changes to notification and the consequences for certificates. Depending on the circumstances, involvement from the responsible authorities and another appropriately designated Notified Body may be necessary.
Manufacturers should respond promptly to any notification concerning their Notified Body’s designation or ability to continue certification activities and establish how continuity of conformity assessment and market access will be maintained.
EU Notified Bodies vs UK Approved Bodies
Although EU Notified Bodies and UK Approved Bodies both perform independent conformity assessment activities, they operate under different regulatory frameworks and should not be treated as interchangeable.
Following the UK’s departure from the European Union, separate conformity assessment systems apply for the EU market and Great Britain.
EU Notified Bodies
For devices requiring third-party conformity assessment under the EU MDR or IVDR, manufacturers must use an appropriately designated EU Notified Body.
An EU Notified Body can assess conformity under the relevant EU legislation and, where the applicable requirements are satisfied, issue the certification required to support CE marking.
EU Notified Bodies and their designation scopes can be checked through the European Commission’s NANDO database.
UK Approved Bodies
For the Great Britain market, the MHRA designates UK Approved Bodies to undertake conformity assessment against the applicable requirements of the UK Medical Devices Regulations 2002.
Where third-party conformity assessment is required for the UKCA route, an appropriately designated UK Approved Body can assess the manufacturer and device and issue the relevant certification supporting application of the UKCA marking.
The current list and designation scopes of UK Approved Bodies are maintained by the MHRA.
Can a UK Approved Body Issue an EU CE Certificate?
No. A UK Approved Body acting in its Great Britain capacity cannot issue the EU MDR or IVDR certification required for CE marking.
For mandatory third-party conformity assessment supporting an EU CE mark, manufacturers need an EU-recognised Notified Body with the appropriate designation.
Similarly, UKCA marking is not recognised as a route to placing a device on the EU market.
What About CE Marked Devices in Great Britain?
This distinction is particularly important because CE marked medical devices continue to be accepted in Great Britain under transitional arrangements.
As of September 2026, EU MDR-compliant general medical devices and EU IVDR-compliant IVDs can currently be placed on the Great Britain market until 30 June 2030. Different transitional deadlines apply to certain devices relying on the former EU Directives.
The UK Government has also consulted on proposals concerning longer-term recognition of CE-marked medical devices, so manufacturers should check the current MHRA requirements when planning future UK market access.
What About Northern Ireland?
Northern Ireland has different arrangements from Great Britain.
A CE mark continues to be relevant for devices placed on the Northern Ireland market. Where a UK conformity assessment body is used under the applicable Northern Ireland arrangements, the UKNI marking is used alongside the CE marking.
A device carrying CE + UKNI cannot subsequently be placed on the EU market on the basis of that conformity assessment.
Choosing the Correct Conformity Assessment Body
Manufacturers should therefore first determine which market they intend to access:
European Union → EU MDR/IVDR → EU Notified Body → CE marking
Great Britain → UK MDR 2002 → UK Approved Body where required → UKCA marking
The regulatory strategy becomes more complex where manufacturers intend to supply devices across both the EU and UK, particularly while Great Britain continues to recognise qualifying CE-marked devices under its transitional arrangements.
Planning to Place a Medical Device on the UK Market?
The regulatory framework for medical devices in Great Britain differs from the EU MDR and IVDR. Learn about UKCA marking, UK Approved Bodies, MHRA registration, UK Responsible Persons and the requirements of the UK Medical Devices Regulations in our Complete Guide to UK Medical Device Regulations.
How Patient Guard Can Help with Notified Body Preparation
Preparing for Notified Body assessment can be one of the most demanding stages of bringing a medical device or IVD to the European market.
Patient Guard supports manufacturers in preparing their quality management systems, Technical Documentation and supporting regulatory evidence for MDR and IVDR conformity assessment.
Our role is not to act as the Notified Body or guarantee certification. Instead, we help manufacturers identify and address regulatory gaps before and during the conformity assessment process.
Regulatory Strategy and Gap Assessment
Before approaching a Notified Body, we can review the manufacturer’s existing regulatory position and identify areas requiring further work.
This can include reviewing:
- device classification and regulatory pathway;
- conformity assessment strategy;
- Technical Documentation structure;
- QMS readiness;
- applicable standards and regulatory requirements;
- clinical or performance evidence;
- risk management;
- verification and validation; and
- PMS and PMCF/PMPF requirements.
This provides manufacturers with a clearer understanding of what needs to be completed before formal assessment.
Technical Documentation Preparation and Review
Patient Guard can support the preparation, review and remediation of MDR and IVDR Technical Documentation.
Depending on the device and project scope, this can include support with:
- device descriptions and intended purpose;
- classification rationale;
- General Safety and Performance Requirements;
- risk management;
- Clinical Evaluation;
- IVDR Performance Evaluation;
- Biological Evaluation;
- verification and validation documentation;
- labelling and Instructions for Use;
- PMS and PMCF/PMPF documentation; and
- declarations and supporting regulatory documentation.
We can also perform gap assessments of existing Technical Documentation to identify inconsistencies or missing evidence before submission.
ISO 13485 and QMS Readiness
Patient Guard supports manufacturers with the development and implementation of ISO 13485 quality management systems aligned with their regulatory activities.
Support can include QMS implementation, procedure development, internal audits, management review preparation, CAPA, supplier controls and preparation for external certification or regulatory audits.
Clinical, Biological and Performance Evidence
Notified Body questions frequently extend beyond the structure of the Technical Documentation into the quality of the underlying scientific and clinical evidence.
Patient Guard’s regulatory specialists can support manufacturers with Clinical Evaluation, Biological Evaluation, IVDR Performance Evaluation, PMCF and PMPF, helping ensure these activities are integrated with risk management and the wider regulatory strategy.
Notified Body Readiness Reviews
Before formal assessment, Patient Guard can conduct a structured readiness review to identify potential deficiencies that could otherwise result in questions or findings during Notified Body assessment.
This can help manufacturers enter conformity assessment with a more mature and internally consistent regulatory submission.
Support During Notified Body Assessment
Where questions or findings are raised during assessment, Patient Guard can support manufacturers in reviewing the Notified Body’s comments, identifying the underlying regulatory issue and preparing appropriate documentation or remediation activities.
Responsibility for demonstrating conformity remains with the manufacturer, but having experienced regulatory support can help ensure that responses are structured, evidence-based and appropriately integrated across the Technical Documentation and QMS.
Frequently Asked Questions About Notified Bodies
A Notified Body is an independent organisation designated by an EU Member State to assess whether certain medical devices and in vitro diagnostic medical devices comply with the requirements of the EU Medical Device Regulation (EU MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR). Where required, a Notified Body conducts conformity assessments, audits Quality Management Systems, reviews Technical Documentation and issues CE certificates that allow manufacturers to place compliant devices on the European market.
Most Class IIa, Class IIb and Class III medical devices require assessment by a Notified Body before they can be CE marked under the EU MDR. Certain Class I devices, including sterile devices, devices with a measuring function and reusable surgical instruments, also require limited Notified Body involvement. Under the IVDR, the majority of in vitro diagnostic medical devices also require Notified Body certification due to the increased regulatory requirements introduced by Regulation (EU) 2017/746.
A Notified Body is an independent conformity assessment organisation designated to evaluate medical devices against the requirements of the MDR or IVDR. A Competent Authority is the national regulatory authority responsible for enforcing medical device legislation within its country. For example, the MHRA acts as the Competent Authority in the United Kingdom, while authorities such as BfArM in Germany oversee regulatory enforcement within their respective Member States.
Manufacturers should select a Notified Body that has the appropriate scope of designation for their type of medical device or IVD. Other important considerations include experience with similar technologies, available certification capacity, audit timelines, communication, geographical location and overall reputation. Engaging with a Notified Body early in the product development process can help reduce delays and improve certification planning.
During a Notified Body audit, auditors review the manufacturer’s Quality Management System, Technical Documentation and regulatory processes to verify compliance with the applicable regulations. The audit typically includes document reviews, interviews with key personnel, inspection of manufacturing facilities where applicable and assessment of supporting evidence such as Clinical Evaluation Reports, Risk Management Files, Post-Market Surveillance activities and CAPA records. Any identified nonconformities must be addressed before certification can proceed.
The time required for MDR certification varies depending on factors such as device classification, the complexity of the technology, the completeness of the Technical Documentation and the availability of the chosen Notified Body. For many manufacturers, the complete certification process can take several months or longer. Early preparation and submission of high-quality documentation can significantly reduce unnecessary delays.
Annex IX, Annex X and Annex XI of the EU MDR define the conformity assessment procedures that manufacturers may use to demonstrate compliance. Annex IX covers Quality Management System assessment and Technical Documentation review, Annex X relates to EU Type Examination, and Annex XI focuses on Product Conformity Verification and Production Quality Assurance. The appropriate route depends on the classification and characteristics of the medical device.
Yes. Manufacturers can transfer from one Notified Body to another when appropriate, although the process requires careful planning to ensure certification continuity. The new Notified Body will normally review existing certification, Technical Documentation and Quality Management System information before issuing new certificates. Manufacturers should avoid allowing certification to lapse during any transfer process.
If a Notified Body loses its designation, manufacturers may need to transfer their certification to another designated Notified Body to maintain compliance and continue placing devices on the European market. The exact process depends on the circumstances and transitional arrangements that apply at the time. Manufacturers should begin discussions with an alternative Notified Body as early as possible to minimise disruption.
Yes. Patient Guard supports manufacturers throughout the entire Notified Body certification process. Our services include Technical Documentation preparation, Clinical Evaluation Reports, Biological Evaluation Reports, Risk Management documentation, ISO 13485 Quality Management Systems, General Safety and Performance Requirements (GSPR) checklists, Post-Market Surveillance planning, mock audits and regulatory strategy. We work closely with manufacturers to identify compliance gaps, strengthen regulatory evidence and improve readiness before engaging with a Notified Body.
List of EU Notified Bodies
| Notified Body Name | Country | Identification Number | MDR | IVDR |
|---|---|---|---|---|
| BSI Group The Netherlands B.V. | Netherlands | 2797 | Yes | Yes |
| DEKRA Certification GmbH | Germany | 0124 | Yes | Yes |
| DEKRA Certification B.V. | Netherlands | 0344 | Yes | Yes |
| DNV Product Assurance AS | Norway | 2460 | Yes | Yes |
| Eurofins Product Testing Italy S.r.l. | Italy | 0477 | Yes | Yes |
| GMED SAS | France | 0459 | Yes | Yes |
| IMQ S.p.A. | Italy | 0051 | Yes | Yes |
| Intertek Medical Notified Body AB | Sweden | 2862 | Yes | Yes |
| NSAI (National Standards Authority of Ireland) | Ireland | 0050 | Yes | Yes |
| SGS Fimko Oy | Finland | 0598 | Yes | Yes |
| TÜV Rheinland LGA Products GmbH | Germany | 0197 | Yes | Yes |
| TÜV SÜD Product Service GmbH | Germany | 0123 | Yes | Yes |
Correct as of 22nd September 2026
References
This guide is based on the EU Medical Device Regulation (MDR), EU In Vitro Diagnostic Medical Device Regulation (IVDR), European Commission guidance and official information relating to the designation, responsibilities, conformity assessment activities and oversight of Notified Bodies for medical devices and IVDs.
| Organisation | Reference | Why it's relevant |
|---|---|---|
| European Union | Regulation (EU) 2017/745 – Medical Device Regulation (MDR) | Establishes the regulatory framework for medical devices in the European Union, including device classification, conformity assessment, Notified Body designation and oversight, Technical Documentation, clinical evaluation, CE marking and post-market requirements. Chapters IV and V and Annexes VII, IX, X and XI are particularly relevant to Notified Body activities. |
| European Union | Regulation (EU) 2017/746 – In Vitro Diagnostic Medical Device Regulation (IVDR) | Establishes the regulatory framework for in vitro diagnostic medical devices, including IVD classification, conformity assessment, Performance Evaluation, Notified Body involvement and ongoing regulatory obligations. It significantly expanded the number of IVDs requiring independent Notified Body assessment. |
| European Commission | Notified Bodies for Medical Devices | Provides the European Commission's official overview of the role and designation of Notified Bodies under the MDR and IVDR, including information on designation, monitoring, standard fees and the Notified Body Coordination Group. |
| European Commission | NANDO – New Approach Notified and Designated Organisations | Provides the official European Commission database of designated Notified Bodies. Manufacturers can use NANDO to confirm whether a Notified Body is designated under the MDR or IVDR and review the scope of conformity assessment activities and device types covered by its designation. |
| European Commission | EUDAMED – Notified Bodies and Certificates Module | Explains the EUDAMED module used for information relating to Notified Bodies and certificates, including certificates issued, amended, supplemented, suspended, reinstated, withdrawn or refused. Use of this module became mandatory from 28 May 2026. |
| European Commission / MDCG | MDCG Guidance Documents – Notified Bodies | Provides Medical Device Coordination Group guidance relating to Notified Body designation, notification, assessment and other MDR and IVDR conformity assessment matters. The collection is updated as new MDCG guidance is issued. |
| European Commission / MDCG | MDCG 2022-13 Rev.1 – Designation, Re-assessment and Notification of Conformity Assessment Bodies and Notified Bodies | Provides detailed guidance on the designation, re-assessment and notification process for conformity assessment bodies seeking designation as Notified Bodies under the MDR and IVDR, including notification through NANDO. |
| European Commission | Notified Bodies – European Commission Single Market | Provides broader European Commission guidance on the role, responsibilities and oversight of Notified Bodies, including requirements relating to competence, independence, confidentiality and the use of the NANDO database. |
Notified Body designation and scope can change over time. Manufacturers should always verify the current designation and authorised scope of a prospective Notified Body using the European Commission's NANDO database before entering into a conformity assessment agreement.
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