Updated: 23rd September 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder and CEO)
What Is the Role of a Notified Body?
A Notified Body is an independent conformity assessment organisation designated to assess whether certain medical devices and in vitro diagnostic medical devices meet the requirements of the EU Medical Device Regulation (MDR 2017/745) or EU In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746).
Its role is to provide independent regulatory assessment where third-party involvement is required before a manufacturer can place a device on the European market.
Depending on the device and applicable conformity assessment route, the Notified Body may assess areas including:
- the manufacturer’s Quality Management System;
- Technical Documentation;
- risk management;
- clinical or performance evidence;
- verification and validation;
- manufacturing and supplier controls;
- labelling and Instructions for Use; and
- post-market surveillance and PMCF or PMPF arrangements.
The Notified Body does not develop the device or prepare the manufacturer’s regulatory documentation. Its purpose is to independently determine whether the manufacturer has demonstrated conformity with the applicable regulatory requirements.
Where the assessment is successfully completed, the Notified Body can issue the relevant certificate required to support the manufacturer’s EU Declaration of Conformity and CE marking.
Its involvement also continues after initial certification. Through surveillance audits and other conformity assessment activities, the Notified Body helps verify that the manufacturer continues to meet the applicable requirements throughout the certification lifecycle.
Notified Bodies Are Independent Assessors
An important distinction is that a Notified Body is not a regulatory consultant.
It must maintain independence and impartiality when carrying out conformity assessment. Manufacturers therefore remain responsible for establishing their regulatory strategy, maintaining their QMS, preparing Technical Documentation and generating sufficient evidence to demonstrate the safety and performance of their devices.
This independence is fundamental to the European conformity assessment system: the manufacturer demonstrates conformity, while the Notified Body independently assesses the evidence supporting that conformity.
Looking for a Complete Guide to Notified Bodies?
This article explains the role of Notified Bodies in medical device certification. If you're looking for a comprehensive guide covering Notified Body designation, conformity assessment routes, audits, certification, CE marking, MDR and IVDR requirements, read our Complete Guide to Notified Bodies.
When Does a Notified Body Become Involved?
Not every medical device requires assessment by a Notified Body. Whether one is required depends primarily on the device classification and applicable conformity assessment route.
Under the EU MDR, manufacturers of most Class I medical devices can complete conformity assessment without a Notified Body. However, Notified Body involvement is required for specific aspects of:
- Class Is devices supplied in a sterile condition;
- Class Im devices with a measuring function; and
- Class Ir reusable surgical instruments.
For Class IIa, Class IIb and Class III medical devices, Notified Body involvement is generally required before the device can be CE marked and placed on the EU market.
What About IVDs?
The IVDR significantly increased the role of Notified Bodies in the conformity assessment of in vitro diagnostic medical devices.
Under the IVDR:
- Class A IVDs are generally self-declared by the manufacturer;
- Class A sterile devices require limited Notified Body involvement relating to sterility; and
- Class B, Class C and Class D IVDs generally require Notified Body conformity assessment.
The higher the regulatory risk associated with the device, the greater the level of independent assessment that may be required.
The Notified Body Must Have the Correct Scope
Manufacturers cannot simply select any organisation operating as a Notified Body.
The chosen body must be designated under the applicable MDR or IVDR and its designation must cover the relevant device types and conformity assessment activities.
This is particularly important for manufacturers developing specialist technologies such as software, implantable devices, combination products or particular types of IVD.
The European Commission’s NANDO database provides the official information on Notified Body designation and scope.
What Does a Notified Body Assess During Certification?
The purpose of Notified Body assessment is to determine whether the manufacturer has provided sufficient evidence to demonstrate that the device and its supporting quality system meet the applicable requirements of the MDR or IVDR.
The exact scope of assessment depends on the device, its classification and the conformity assessment route. However, several areas commonly form part of the review.
Quality Management System
Where the conformity assessment route includes assessment of the manufacturer’s Quality Management System, the Notified Body will evaluate whether appropriate processes have been established, implemented and maintained.
This may include:
- design and development controls;
- document and record control;
- supplier and subcontractor management;
- production and process controls;
- competence and training;
- risk management;
- complaint handling and vigilance;
- CAPA and nonconformity management;
- post-market surveillance; and
- change control.
ISO 13485 is widely used as the framework for medical device quality management systems, but certification to ISO 13485 alone does not demonstrate conformity with all applicable MDR or IVDR requirements.
Need to Understand ISO 13485?
ISO 13485 is the internationally recognised quality management system standard for medical device manufacturers and is widely used to support regulatory compliance under the EU MDR and IVDR. Learn about its requirements, structure and role in medical device certification in our Complete Guide to ISO 13485.
Technical Documentation
The Notified Body may review the manufacturer’s Technical Documentation to determine whether the device has been adequately described and whether sufficient evidence supports its safety and performance.
The assessment can consider areas such as:
- device description and intended purpose;
- classification;
- design and manufacturing information;
- General Safety and Performance Requirements;
- risk management;
- verification and validation;
- labelling and Instructions for Use; and
- post-market documentation.
The documentation should tell a consistent regulatory story. Claims made in the intended purpose and labelling should be supported by the risk management, clinical or performance evidence and verification and validation activities.
Preparing Your Medical Device Technical File?
Technical Documentation provides the evidence a Notified Body needs to assess whether a medical device meets the applicable regulatory requirements. Learn how to organise device information, risk management, clinical evidence, verification and validation, labelling and post-market documentation in our Guide to Structuring a Medical Device Technical File.
Clinical or Performance Evidence
For medical devices, the Notified Body may assess the manufacturer’s Clinical Evaluation and the clinical evidence supporting the device’s intended purpose, safety, performance and claimed clinical benefits.
For IVDs, assessment may include the Performance Evaluation, including scientific validity, analytical performance and clinical performance.
The depth of assessment will depend on the device and applicable regulatory requirements.
Preparing an IVDR Performance Evaluation?
Performance evaluation is central to demonstrating the safety and performance of an IVD under the EU IVDR. Learn how scientific validity, analytical performance and clinical performance are evaluated and documented within the Performance Evaluation Plan and Report in our Complete Guide to IVDR Performance Evaluation.
Preparing a 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.
Risk Management and Verification & Validation
Risk management should demonstrate that risks associated with the device have been systematically identified, evaluated and controlled throughout its lifecycle.
The Notified Body may examine whether identified risk controls are supported by appropriate verification and validation evidence.
Depending on the device, this could include evidence relating to areas such as:
- electrical safety and electromagnetic compatibility;
- software verification and validation;
- cybersecurity;
- usability;
- biological safety;
- sterilisation;
- cleaning and disinfection;
- packaging;
- shelf life; and
- functional or performance testing.
Need to Strengthen Your Medical Device Risk Management?
Risk management is a fundamental part of demonstrating medical device safety and must remain aligned with design controls, verification and validation, clinical evidence and post-market information. Learn how ISO 14971 supports the identification, evaluation, control and ongoing monitoring of medical device risks in our Complete Guide to ISO 14971 Medical Device Risk Management.
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 regulatory expectations and key validation areas including software, usability, electrical safety, cleaning, sterilisation and packaging in our Complete Guide to Medical Device Validation.
Post-Market Arrangements
Notified Body assessment is not limited to evidence generated before market entry.
Manufacturers must also demonstrate that appropriate systems exist to monitor the device once it is placed on the market. This can include Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF), Post-Market Performance Follow-up (PMPF), vigilance and trend reporting, where applicable.
These activities provide ongoing evidence about device performance and can identify new or changing risks that need to feed back into the manufacturer’s risk management, clinical or performance evaluation and Technical Documentation.
Preparing Your Post-Market Surveillance System?
Post-market surveillance is a continuous regulatory obligation that helps manufacturers monitor the safety and performance of medical devices throughout their lifecycle. Learn about PMS plans, reports, post-market data, vigilance, trend reporting and how PMS feeds back into risk management and clinical evaluation in our Complete Guide to Medical Device Post-Market Surveillance.
The Notified Body’s Role During the Certification Process
Once a manufacturer has selected an appropriately designated Notified Body and is ready to begin conformity assessment, the Notified Body moves from being a potential assessment organisation to an active independent reviewer of the manufacturer and its regulatory evidence.
Although the exact process varies according to the device and conformity assessment route, the Notified Body’s role typically progresses through several stages.
1. Application and Initial Review
The manufacturer submits an application to the Notified Body covering the devices and conformity assessment activities required.
The Notified Body will establish whether the application falls within its designated scope and whether it has the necessary expertise and resources to undertake the assessment.
Manufacturers should therefore engage with potential Notified Bodies early rather than waiting until immediately before their intended market launch.
2. Quality Management System Assessment
Where QMS assessment forms part of the applicable conformity assessment route, the Notified Body will assess whether the manufacturer has established and implemented an appropriate quality management system.
This normally involves reviewing documented procedures and conducting an audit of the manufacturer.
The assessment is not limited to whether suitable procedures exist. Auditors may examine records and objective evidence to determine whether those procedures are being consistently implemented in practice.
3. Technical Documentation Assessment
The Notified Body may then review the Technical Documentation for the relevant device or representative devices, depending on the applicable conformity assessment requirements.
The assessor may examine whether the documentation demonstrates conformity with the MDR or IVDR and whether the manufacturer’s regulatory claims are supported by appropriate evidence.
This can involve specialist reviewers examining areas such as clinical evidence, biological safety, software, sterilisation, electrical safety or IVD performance.
4. Questions and Findings
Notified Body assessment is often an iterative process.
Assessors may request clarification, additional evidence or corrections where the submitted documentation does not sufficiently demonstrate conformity.
Where nonconformities or deficiencies are identified, the manufacturer may need to:
- investigate the underlying issue;
- provide additional evidence;
- revise Technical Documentation;
- update QMS processes;
- implement corrective actions; or
- demonstrate that identified actions have been effectively completed.
Clear, structured responses are important. Correcting one document without considering its impact elsewhere can create further inconsistencies across the regulatory documentation.
5. Certification Decision
Once the required assessments have been completed and outstanding issues have been satisfactorily addressed, the Notified Body can make its certification decision.
Where conformity has been successfully demonstrated, the appropriate certificate or certificates may be issued.
The manufacturer can then complete the remaining regulatory steps necessary for placing the device on the EU market, including preparation of the EU Declaration of Conformity and application of the CE marking, subject to the applicable requirements.
Where a Notified Body has been involved in the conformity assessment procedure, its four-digit identification number accompanies the CE marking as required by the MDR or IVDR.
Certification Does Not Transfer Responsibility
Notified Body certification does not transfer regulatory responsibility for the device from the manufacturer to the Notified Body.
The manufacturer remains responsible for ensuring that the device continues to conform with the applicable requirements and that its QMS, Technical Documentation, risk management, clinical or performance evidence and post-market activities remain appropriate and up to date.
This distinction becomes particularly important after certification, because the Notified Body’s role continues through ongoing surveillance.
The Notified Body’s Role After Certification
Notified Body involvement does not end when a certificate is issued. Certification establishes that conformity has been demonstrated at a particular point in time, but manufacturers must continue to meet the applicable MDR or IVDR requirements throughout the device lifecycle.
The Notified Body therefore has an ongoing role in monitoring whether the manufacturer continues to operate its Quality Management System effectively and maintain the conditions under which certification was granted.
Ongoing Surveillance Audits
Following certification, the Notified Body will carry out surveillance activities in accordance with the applicable conformity assessment procedure.
Surveillance audits may examine areas such as:
- continued implementation of the Quality Management System;
- internal audits and management reviews;
- CAPA and nonconformity management;
- supplier controls;
- complaints and vigilance;
- post-market surveillance;
- PMCF or PMPF activities;
- design and manufacturing changes;
- risk management; and
- maintenance of Technical Documentation.
The purpose is to verify that regulatory compliance is being maintained in practice, rather than simply confirming that appropriate documentation existed at the time of initial certification.
Review of Post-Market Information
Information generated after a device enters the market can affect the evidence supporting its continued conformity.
The Notified Body may therefore review relevant post-market information as part of its surveillance activities, including complaints, vigilance information, trends, PMS outputs and PMCF or PMPF results.
Manufacturers should ensure that significant post-market findings feed back into relevant regulatory documentation, including:
PMS → Risk Management → Clinical or Performance Evaluation → Technical Documentation → CAPA
This lifecycle approach helps ensure that new information about the device is appropriately assessed and acted upon.
Changes to the Device or Quality Management System
Certification does not mean that a manufacturer can make unrestricted changes to the device, manufacturing processes or Quality Management System.
Changes should be evaluated through the manufacturer’s change-control process to determine their potential regulatory impact.
Depending on the nature and significance of the change and the applicable certification arrangements, the manufacturer may need to notify the Notified Body and obtain further assessment or approval before implementing it.
Changes potentially affecting areas such as the following require particularly careful consideration:
- intended purpose or indications;
- device design;
- materials;
- software;
- manufacturing processes;
- critical suppliers;
- sterilisation;
- performance characteristics; and
- Quality Management System processes.
The manufacturer should also consider whether a change affects risk management, clinical or performance evidence, verification and validation, labelling or post-market activities.
Unannounced Audits
Notified Bodies may also conduct unannounced audits as part of their surveillance responsibilities.
These provide an additional means of verifying that manufacturers continue to comply with regulatory requirements during normal operations rather than only when a scheduled audit is approaching.
This is another reason why manufacturers should maintain continuous audit readiness rather than treating regulatory compliance as an activity undertaken immediately before an external assessment.
Recertification
Certificates are not indefinite.
Before the applicable certificate expires, the manufacturer will need to complete the necessary recertification activities if it intends to continue relying on that certification.
Manufacturers should plan for recertification well in advance, ensuring that their QMS, Technical Documentation, clinical or performance evidence, risk management and post-market documentation remain current.
Certification Is an Ongoing Relationship
The relationship between the manufacturer and Notified Body should therefore be viewed as an ongoing regulatory relationship rather than a one-time certification exercise.
The manufacturer remains responsible for maintaining conformity, while the Notified Body provides independent ongoing oversight through surveillance, assessment of relevant changes and recertification activities.
This continuing oversight helps ensure that the evidence supporting CE marking remains appropriate throughout the certified device’s lifecycle.
What a Notified Body Does Not Do
Understanding the limits of a Notified Body’s role is just as important as understanding its responsibilities.
A Notified Body provides independent conformity assessment. It does not act as the manufacturer’s regulatory consultant, prepare the manufacturer’s evidence or take responsibility for achieving compliance.
A Notified Body Does Not Prepare Your Technical Documentation
The manufacturer is responsible for preparing and maintaining Technical Documentation that demonstrates conformity with the applicable MDR or IVDR requirements.
A Notified Body may identify deficiencies, request clarification or require additional evidence during its assessment, but it should not write or develop the documentation it is subsequently responsible for independently assessing.
Manufacturers should therefore ensure that their Technical Documentation is sufficiently mature before entering formal conformity assessment.
A Notified Body Does Not Build Your Quality Management System
The Notified Body assesses whether the manufacturer’s Quality Management System meets the applicable requirements and is effectively implemented.
It does not establish the QMS on the manufacturer’s behalf.
The manufacturer remains responsible for developing, implementing and maintaining appropriate processes for areas such as:
- document and record control;
- design and development;
- supplier management;
- production controls;
- risk management;
- complaints and vigilance;
- CAPA;
- internal audits;
- management review; and
- post-market surveillance.
A Notified Body Does Not Generate Your Clinical or Performance Evidence
Manufacturers must establish the clinical or performance evidence necessary to support their devices.
For medical devices, this includes maintaining an appropriate Clinical Evaluation. For IVDs, manufacturers must establish the required Performance Evaluation.
The Notified Body assesses whether that evidence is sufficient to support conformity. It does not generate the evidence for the manufacturer.
A Notified Body Does Not Decide Your Regulatory Strategy for You
Manufacturers need to establish their regulatory strategy before approaching a Notified Body.
This includes determining the device’s:
- intended purpose;
- classification;
- applicable regulatory requirements;
- conformity assessment route;
- applicable standards and specifications; and
- evidence requirements.
A Notified Body may determine during assessment that a manufacturer’s proposed approach is not adequately justified, but this should not be confused with acting as the manufacturer’s regulatory adviser.
A Notified Body Does Not Guarantee Certification
Submitting an application to a Notified Body does not mean that certification will automatically be granted.
The manufacturer must demonstrate conformity through its QMS, Technical Documentation and supporting evidence. Deficiencies may result in questions, nonconformities, additional assessment or further evidence being required before a certification decision can be made.
Where conformity cannot be adequately demonstrated, certification may not be issued.
The Manufacturer Remains Responsible for Compliance
Ultimately, regulatory responsibility remains with the manufacturer.
The manufacturer is responsible for the safety and performance of the device, maintaining regulatory documentation, operating the QMS, monitoring post-market performance and continuing to demonstrate conformity throughout the device lifecycle.
The distinction can be summarised simply:
The manufacturer builds and maintains the evidence of conformity. The Notified Body independently assesses that evidence.
This is also why manufacturers often use independent regulatory specialists to help prepare for conformity assessment: the consultant can support the development and review of the regulatory evidence, while the Notified Body remains independent and assesses it.
How to Prepare for Notified Body Assessment
Preparation for Notified Body assessment should begin well before the formal application or audit. Manufacturers that enter conformity assessment with an incomplete QMS or fragmented Technical Documentation are more likely to face additional questions, findings and delays.
The objective should be to present a complete, consistent and evidence-based demonstration of conformity.
Confirm the Regulatory Strategy
Before submitting documentation, manufacturers should confirm the fundamental regulatory position for the device, including:
- intended purpose and indications;
- device classification;
- applicable MDR or IVDR requirements;
- conformity assessment route;
- applicable standards and Common Specifications, where relevant; and
- the scope of Notified Body involvement required.
These decisions influence almost every subsequent part of the regulatory documentation.
Review the Technical Documentation as a Complete Package
Technical Documentation should not be reviewed as a collection of isolated reports.
The Notified Body will consider how the different elements relate to one another. Manufacturers should therefore check that information is consistent across the:
- device description;
- intended purpose;
- labelling and Instructions for Use;
- risk management documentation;
- Clinical Evaluation or Performance Evaluation;
- verification and validation;
- biological evaluation, where applicable;
- usability documentation;
- PMS and PMCF/PMPF documentation; and
- General Safety and Performance Requirements.
For example, a performance claim appearing in the IFU should be supported by appropriate verification or clinical evidence and considered within the risk management documentation.
Ensure the QMS Is Implemented
Having a set of approved procedures is not sufficient if those procedures are not being followed.
Before assessment, manufacturers should confirm that their QMS is supported by appropriate records demonstrating implementation.
This may include evidence of:
- internal audits;
- management reviews;
- training;
- supplier evaluations;
- design reviews;
- CAPA;
- change controls;
- complaint handling;
- PMS activities; and
- document and record control.
Staff should also understand their responsibilities and be able to explain how the relevant processes operate in practice.
Check That Evidence Supports the Device Claims
The claims made for the device should be supported by appropriate evidence.
Manufacturers should review whether their clinical or performance evidence, risk management and verification and validation activities adequately support the device’s intended purpose and claimed benefits and performance.
Unsupported or inconsistently documented claims can result in additional questions during assessment.
Conduct an Internal Readiness Review
A structured readiness review before formal assessment can help identify gaps while the manufacturer still has time to address them.
This may involve:
QMS review → Technical Documentation review → Evidence review → Cross-document consistency check → Gap remediation → Notified Body submission
An internal audit or independent regulatory gap assessment can also provide useful insight into areas that may attract attention during formal assessment.
Prepare for Questions and Findings
Manufacturers should expect interaction with the Notified Body during conformity assessment.
If questions or findings are raised, responses should address the underlying issue rather than simply changing the individual document identified by the assessor.
A finding in one area may have implications elsewhere. For example, new clinical information could require updates to the Clinical Evaluation, risk management, benefit-risk assessment, labelling and PMS activities.
Maintaining strong document control and clear traceability between regulatory evidence can make this process considerably easier.
Aim for Continuous Readiness
Notified Body preparation should not become a last-minute exercise immediately before an audit.
A mature regulatory system keeps the QMS, Technical Documentation and supporting evidence current throughout the product lifecycle.
This approach not only supports the initial certification assessment but also prepares the manufacturer for surveillance audits, assessment of changes and eventual recertification.
How Patient Guard Can Help with Notified Body Preparation
Preparing for Notified Body assessment requires more than assembling documents shortly before submission. The Quality Management System, Technical Documentation and supporting evidence need to work together to provide a clear and consistent demonstration of conformity.
Patient Guard can support medical device and IVD manufacturers throughout their preparation for MDR and IVDR conformity assessment.
Technical Documentation Support
We can help manufacturers prepare, review and update Technical Documentation in line with the applicable MDR or IVDR requirements.
Depending on the device and scope of the project, support can include:
- Technical Documentation gap assessments;
- device descriptions and regulatory strategy;
- classification rationale;
- General Safety and Performance Requirements;
- risk management documentation;
- verification and validation documentation;
- labelling and Instructions for Use;
- Clinical Evaluation;
- Biological Evaluation;
- IVDR Performance Evaluation;
- PMS, PMCF and PMPF documentation; and
- review of existing documentation for consistency and completeness.
Quality Management System Support
Patient Guard can support manufacturers with the development, implementation and maintenance of medical device Quality Management Systems, including systems based on ISO 13485.
This can include procedure development, internal audits, management review, CAPA, supplier controls, design and development processes, document control and preparation for external assessment.
Notified Body Readiness and Gap Assessments
Before formal assessment, we can conduct a structured review of the manufacturer’s existing QMS and regulatory documentation to identify potential gaps.
This provides an opportunity to address weaknesses before they become formal Notified Body findings.
A readiness review can also examine the consistency between different elements of the regulatory evidence, helping ensure that the intended purpose, claims, risk management, clinical or performance evidence, verification and validation and post-market activities remain aligned.
Support with Notified Body Findings
Where a manufacturer receives questions or findings during assessment, Patient Guard can help review the issues raised and determine what documentation or evidence may need to be strengthened.
This may involve updating individual documents or considering whether the finding has wider implications across the Technical Documentation or QMS.
The manufacturer remains responsible for demonstrating conformity and responding to its Notified Body, while Patient Guard can provide the regulatory and technical support needed to prepare an appropriate response.
Supporting Manufacturers Through the Certification Journey
Whether a manufacturer is preparing for its first Notified Body assessment, transitioning to the MDR or IVDR, addressing assessment findings or preparing for surveillance and recertification, early preparation can reduce avoidable regulatory delays.
Patient Guard’s medical device regulatory and quality specialists can support manufacturers with the QMS, Technical Documentation and regulatory evidence required to approach Notified Body assessment with greater confidence.
Frequently Asked Questions About Notified Bodies
A Notified Body is an independent conformity assessment organisation designated to assess whether certain medical devices and IVDs meet the applicable requirements of the EU MDR or IVDR. Depending on the conformity assessment route, this may include assessment of the manufacturer’s Quality Management System, Technical Documentation and supporting regulatory evidence.
No. Most Class I medical devices can be self-declared under the MDR, although Notified Body involvement is required for specific aspects of Class Is, Im and Ir devices. Class IIa, IIb and III devices generally require Notified Body involvement.
Under the IVDR, Class A IVDs are generally self-declared, except where supplied sterile, while Classes B, C and D generally require Notified Body conformity assessment.
No. The manufacturer affixes the CE marking after completing the applicable conformity assessment procedure and drawing up the EU Declaration of Conformity. Where a Notified Body is involved in the conformity assessment, its four-digit identification number accompanies the CE marking as required.
Depending on the device and conformity assessment route, a Notified Body may assess the manufacturer’s Quality Management System, Technical Documentation, risk management, clinical or performance evidence, verification and validation, labelling and post-market arrangements.
No. The manufacturer is responsible for preparing and maintaining its Technical Documentation and demonstrating conformity with the MDR or IVDR. The Notified Body independently assesses the evidence and may identify deficiencies or request additional information.
No. ISO 13485 provides an internationally recognised framework for medical device quality management systems, but ISO 13485 certification alone does not demonstrate conformity with all MDR or IVDR requirements or provide the regulatory certification required for CE marking where Notified Body involvement is necessary.
No. The organisation must be designated under the applicable MDR or IVDR and its designation must cover the relevant conformity assessment activities and device types. Manufacturers should verify the current designation and scope through the European Commission’s NANDO database.
The Notified Body may raise questions or findings requiring the manufacturer to provide clarification, additional evidence or corrective action. Depending on the issue, this could require updates to the Technical Documentation, QMS or supporting regulatory evidence before the assessment can be successfully completed.
No. Notified Bodies have an ongoing role following certification, which can include surveillance audits, assessment of relevant changes, review of regulatory and post-market information and recertification activities.
The manufacturer must therefore continue maintaining its QMS and regulatory documentation throughout the device lifecycle.
A Notified Body must maintain the independence and impartiality required for conformity assessment. Its role is to assess whether conformity has been demonstrated rather than to develop the manufacturer’s regulatory strategy or prepare the documentation it will subsequently assess.
Manufacturers should ensure that their regulatory strategy is established, their QMS is implemented, their Technical Documentation is complete and their supporting evidence is consistent.
An internal audit or independent readiness assessment before formal submission can help identify deficiencies before they become findings during Notified Body assessment.
Yes. Patient Guard can support manufacturers with MDR and IVDR Technical Documentation, ISO 13485 Quality Management Systems, Clinical Evaluation, Biological Evaluation, Performance Evaluation, risk management, PMS, PMCF/PMPF and regulatory gap assessments.
Patient Guard can also support manufacturers in reviewing and addressing questions or findings raised during Notified Body assessment, while the Notified Body remains responsible for the independent conformity assessment and certification decision.
References
This article is based on the requirements of the EU Medical Device Regulation (MDR), In Vitro Diagnostic Medical Device Regulation (IVDR), European Commission information and Medical Device Coordination Group (MDCG) guidance relating to Notified Bodies, conformity assessment, certification and ongoing surveillance.
| Organisation | Reference | Why it's relevant |
|---|---|---|
| European Union | Regulation (EU) 2017/745 on Medical Devices (MDR) | Establishes the regulatory framework for medical devices in the EU, including device classification, conformity assessment, Notified Body involvement, Technical Documentation, Quality Management Systems, CE marking and post-market obligations. |
| European Union | Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) | Establishes the EU regulatory framework for IVDs, including classification, performance evaluation, conformity assessment, Notified Body involvement, certification and post-market requirements. |
| European Commission | Notified Bodies – Medical Devices | Provides European Commission information on Notified Bodies and their role within the MDR and IVDR regulatory framework, including designation and conformity assessment responsibilities. |
| European Commission | NANDO – Notified Bodies | Provides the official European Commission resource for identifying designated Notified Bodies and reviewing the legislation and conformity assessment activities for which they have been notified. |
| European Union | MDR Annex VII – Requirements to Be Met by Notified Bodies | Defines requirements applying to Notified Bodies, including organisational structure, independence, impartiality, personnel competence, assessment activities and other responsibilities under the MDR. |
| European Union | MDR Annex IX – Conformity Assessment Based on a Quality Management System and Technical Documentation | Sets out a principal MDR conformity assessment route involving assessment of the manufacturer's Quality Management System and Technical Documentation, together with surveillance following certification. |
| Medical Device Coordination Group | MDCG 2019-6 Rev.5 – Questions and Answers: Requirements Relating to Notified Bodies | Provides detailed MDCG guidance and clarification on requirements applying to Notified Bodies under the MDR and IVDR, including independence, organisational requirements, personnel, assessment activities and other aspects of Notified Body operation. |
| Medical Device Coordination Group | MDCG Endorsed Documents and Other Guidance | Provides the European Commission's current collection of MDCG guidance supporting the implementation of the MDR and IVDR, including guidance specifically relating to Notified Bodies and conformity assessment. |
Manufacturers should always confirm the current designation and scope of a Notified Body before entering conformity assessment. Notified Body designation and scope can change, and the organisation must be appropriately designated for the applicable legislation and conformity assessment activities.
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