Updated: 1st July 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder and CEO)
Understanding the Role of Notified Bodies
Obtaining CE marking under the EU Medical Device Regulation (EU MDR 2017/745) or In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746) is one of the most significant milestones for any medical device manufacturer. For many devices, this process cannot be completed without the involvement of a Notified Body.
Notified Bodies are independent organisations designated by European Union Member States to assess whether medical devices and in vitro diagnostic medical devices comply with the applicable regulatory requirements before they are placed on the European market. They provide an impartial conformity assessment, reviewing everything from a manufacturer’s Quality Management System (QMS) and Technical Documentation to clinical evidence, post-market surveillance activities and regulatory processes.
Under the MDR and IVDR, the responsibilities of Notified Bodies have expanded significantly compared with the previous Medical Device Directives. They are now expected to perform far more detailed assessments of Technical Documentation, Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), Risk Management Files, Post-Market Clinical Follow-up (PMCF) activities and manufacturers’ Quality Management Systems.
Selecting the right Notified Body, preparing robust regulatory documentation and understanding the conformity assessment process are therefore essential for achieving CE marking efficiently and maintaining long-term regulatory compliance.
In this guide, we explain what Notified Bodies do, when they are required, how the conformity assessment process works, what manufacturers should expect during audits and how to prepare for successful certification under the MDR and IVDR.
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.
Notified Bodies in the EU
Regulatory Framework
In the EU, medical devices must comply with Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic devices. These rules are stricter than the previous Directives, making the role of Notified Bodies more demanding.
Designation and Scope
EU Member States designate Notified Bodies, which are listed in the European Commission’s NANDO database. Each Notified Body has specific scopes, such as:
General medical devices (Class I, IIa, IIb, III).
In vitro diagnostic devices (IVDs).
Specialized areas like software or implantable devices.
Manufacturers must choose a Notified Body that matches their product’s classification.
Key Tips for Manufacturers
Plan Ahead: Notified Body capacity is limited, so engage early.
Focus on Clinical Evidence: High-risk devices require robust clinical data.
Prepare for Audits: Ongoing surveillance audits are part of compliance.
How Notified Bodies Fit into the EU MDR Certification Process
Notified Bodies play a central role in the conformity assessment process required for many medical devices and in vitro diagnostic medical devices marketed within the European Union. Their involvement provides independent assurance that manufacturers have demonstrated compliance with the applicable regulatory requirements before a device can bear the CE mark.
For most Class IIa, Class IIb and Class III medical devices, together with the majority of IVDs regulated under the IVDR, manufacturers cannot self-certify compliance. Instead, they must work with a designated Notified Body to review both their Quality Management System and the evidence supporting the safety and performance of their devices.
The certification process typically begins long before a formal application is submitted. Manufacturers should first determine the classification of their device, identify the appropriate conformity assessment route and select a Notified Body with the correct scope of designation for their technology.
Following submission of an application, the Notified Body will assess documentation including the manufacturer’s ISO 13485 Quality Management System, Technical Documentation, Risk Management File, Clinical Evaluation Report, Post-Market Surveillance documentation and any applicable Post-Market Clinical Follow-up activities.
Depending on the conformity assessment route, the Notified Body may also perform detailed technical documentation sampling, product testing reviews and on-site audits of manufacturing facilities.
Where compliance is demonstrated, the Notified Body issues the relevant certificates, allowing the manufacturer to prepare the EU Declaration of Conformity and apply the CE mark before placing the device on the European market.
Certification does not end once a certificate has been issued. Notified Bodies continue to monitor manufacturers through surveillance audits, technical documentation reviews and periodic reassessments to ensure continued compliance throughout the lifecycle of the device. Significant changes to the device, manufacturing process or Quality Management System may also require review and approval before implementation.
Understanding how Notified Bodies fit within the broader regulatory framework allows manufacturers to prepare more effectively, avoid unnecessary delays and build stronger long-term relationships with their certification partner.
Understanding the EU MDR Conformity Assessment Routes
One of the most important responsibilities of a Notified Body is performing the conformity assessment required before many medical devices and IVDs can be awarded CE marking. The conformity assessment route determines how a manufacturer demonstrates compliance with the EU MDR or IVDR and how extensively the Notified Body will review the device and the manufacturer’s Quality Management System.
The appropriate conformity assessment route depends primarily on the classification of the device, its intended purpose and the level of risk it presents to patients and users.
For medical devices regulated under the EU MDR, the most common conformity assessment procedures are described within Annex IX, Annex X and Annex XI.
Annex IX – Quality Management System and Technical Documentation Assessment
Annex IX is the conformity assessment route used by most manufacturers of Class IIa, Class IIb and Class III medical devices.
Under this route, the Notified Body assesses both the manufacturer’s Quality Management System and Technical Documentation for the devices within scope..
Typical activities include:
- Auditing the manufacturer’s ISO 13485 Quality Management System.
- Reviewing Technical Documentation.
- Assessing Clinical Evaluation Reports.
- Reviewing Risk Management documentation.
- Evaluating Post-Market Surveillance procedures.
- Conducting surveillance audits throughout the certification period.
This route provides ongoing oversight and is the most widely used conformity assessment pathway under the MDR.
Annex X – EU Type Examination
Annex X focuses on the assessment of a representative sample of a device, often referred to as a “type examination.”
The Notified Body evaluates whether the representative device complies with the applicable General Safety and Performance Requirements before issuing an EU Type Examination Certificate.
Manufacturers using Annex X are normally required to combine this route with additional conformity assessment procedures, such as production quality assurance under Annex XI.
Annex XI – Product Conformity Verification
Annex XI focuses on verifying that manufactured devices remain consistent with the approved design.
Depending on the route selected, the Notified Body may perform:
- Product verification.
- Batch verification.
- Production quality assurance assessments.
- Inspection and testing activities.
Manufacturers choosing Annex XI must demonstrate that production processes consistently produce devices that conform to the approved Technical Documentation and any applicable Type Examination Certificate.
Selecting the Appropriate Route
The conformity assessment route is determined by several factors, including:
- Device classification.
- Whether the device is sterile or has a measuring function.
- Whether it is implantable.
- The technology involved.
- The manufacturer’s Quality Management System.
- The applicable provisions of the MDR or IVDR.
Selecting the correct route at an early stage can significantly reduce certification delays and ensure manufacturers prepare the correct evidence before engaging with a Notified Body.
Although Annex IX is the most common pathway, manufacturers should always confirm the appropriate conformity assessment procedure with their chosen Notified Body before beginning the certification process.
Preparing for a Notified Body Audit
Preparing for a Notified Body audit should begin long before the audit team arrives on site. Successful manufacturers treat regulatory compliance as an ongoing process rather than a one-off exercise before certification.
A well-prepared organisation will have a mature Quality Management System, complete Technical Documentation and documented processes that demonstrate compliance with the EU MDR or IVDR. Auditors are not only assessing documentation—they are also evaluating whether quality processes are effectively implemented throughout the organisation.
Although every audit differs depending on the device classification and conformity assessment route, most Notified Body audits follow a similar structure.
Opening Meeting
The audit normally begins with an opening meeting where the audit team introduces the audit objectives, confirms the scope of the assessment and explains the audit schedule.
Manufacturers should ensure that key personnel are available throughout the audit, including representatives from Regulatory Affairs, Quality Assurance, Clinical Affairs, Manufacturing and Senior Management where appropriate.
Documentation Review
A significant proportion of the audit focuses on documentation.
Typical documentation reviewed includes:
- Quality Manual
- ISO 13485 procedures
- Technical Documentation
- Clinical Evaluation Reports
- Risk Management Files
- Biological Evaluation documentation
- Post-Market Surveillance procedures
- Complaint handling records
- CAPA records
- Internal audit reports
- Management Review records
- Supplier qualification records
- Design and development documentation
- Validation records
Auditors will assess not only whether documentation exists, but whether it remains current, internally consistent and fully supports the manufacturer’s regulatory claims.
Interviews with Personnel
Notified Bodies routinely interview employees responsible for implementing the Quality Management System.
Personnel should understand:
- Their responsibilities.
- Applicable procedures.
- Regulatory requirements.
- How nonconformities are managed.
- Document control processes.
- Risk management activities.
- Complaint handling procedures.
An effective Quality Management System should be understood throughout the organisation rather than existing solely within the Quality department.
Facility Inspection
Where applicable, auditors will inspect manufacturing and warehouse facilities.
Typical areas assessed include:
- Production controls.
- Environmental controls.
- Cleanroom operations.
- Equipment calibration.
- Incoming inspection.
- Product identification.
- Traceability.
- Storage conditions.
- Final release procedures.
The objective is to verify that manufacturing activities match the documented Quality Management System.
Nonconformities
If deficiencies are identified, the Notified Body may raise Nonconformities (NCs).
These are typically classified according to their significance and may require:
- Immediate correction.
- Root cause analysis.
- Corrective Action Plans.
- Objective evidence demonstrating implementation.
Manufacturers should respond promptly and provide clear evidence that corrective actions have been implemented effectively.
Surveillance Audits
Certification is not the end of the process.
Following initial certification, manufacturers should expect regular surveillance audits throughout the certification cycle. These audits confirm that the Quality Management System continues to operate effectively and that Technical Documentation, Clinical Evaluation and Post-Market Surveillance activities remain compliant.
Maintaining continual compliance is considerably easier than attempting to prepare for each audit from scratch.
Common Reasons for Notified Body Certification Delays
One of the most common misconceptions is that certification delays are caused solely by limited Notified Body capacity. While capacity constraints continue to affect review timelines, many delays originate from incomplete or inadequate submissions made by manufacturers.
A well-prepared Technical Documentation package supported by robust clinical evidence and a mature Quality Management System can significantly reduce the likelihood of prolonged review cycles.
Common causes of certification delays include:
Incomplete Technical Documentation
Technical Documentation that lacks sufficient design information, verification and validation evidence, or appropriate cross-referencing often results in multiple rounds of questions from the Notified Body.
Manufacturers should ensure documentation is complete, well organised and fully aligned with Annex II and Annex III of the EU MDR.
Weak Clinical Evidence
Clinical Evaluation Reports remain one of the most frequently challenged areas during MDR certification.
Manufacturers should ensure that clinical evidence adequately supports the intended purpose, claims and safety profile of the device and that Post-Market Clinical Follow-up activities are proportionate to the associated risks.
Inadequate Risk Management
Risk Management Files should demonstrate compliance with ISO 14971 throughout the entire product lifecycle.
Common findings include incomplete hazard identification, weak benefit-risk justifications and poor linkage between risk controls and verification activities.
Quality Management System Findings
Quality Management Systems that have not been fully implemented frequently generate audit findings.
Examples include:
- Incomplete CAPA records.
- Poor supplier controls.
- Missing training records.
- Ineffective document control.
- Weak complaint handling procedures.
Slow Responses to Nonconformities
Even after an audit has been completed, certification can be delayed if manufacturers take too long to respond to audit findings or provide insufficient objective evidence supporting corrective actions.
Maintaining dedicated regulatory resources throughout the certification process helps minimise unnecessary delays.
Manufacturers that invest time in preparing comprehensive documentation before submission typically experience a smoother certification process and reduce the number of clarification requests issued by their Notified Body.
How to Overcome Challenges
Working with Notified Bodies or Approved Bodies can be challenging. Common issues include:
Limited Availability: There are not enough designated bodies, leading to delays.
High Documentation Standards: Technical files must be thorough and precise.
Regulatory Updates: Staying informed about regulatory changes is critical.
How Patient Guard Supports Manufacturers Through the Notified Body Process
Preparing for Notified Body certification requires far more than simply producing technical documentation. Successful certification depends upon demonstrating that your Quality Management System, regulatory documentation and post-market processes operate together as an integrated system.
Patient Guard supports manufacturers throughout every stage of the conformity assessment process, including:
- Notified Body readiness assessments.
- Technical Documentation preparation and review.
- Clinical Evaluation Reports (CERs).
- Performance Evaluation Reports (PERs).
- Risk Management documentation (ISO 14971).
- Biological Evaluation Reports.
- General Safety and Performance Requirements (GSPR) checklists.
- ISO 13485 Quality Management System implementation and auditing.
- Internal audit programmes.
- Post-Market Surveillance and PMCF planning.
- Regulatory strategy and submission planning.
- Management of communications with Notified Bodies during conformity assessment.
Our consultants have extensive experience supporting manufacturers across a wide range of medical devices and in vitro diagnostic devices. We work collaboratively with your team to identify gaps before submission, reduce certification delays and improve the likelihood of a successful first review.
Whether you are preparing a completely new device for CE marking or transitioning an existing product under the MDR or IVDR, Patient Guard can provide practical regulatory support throughout the certification journey.
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 1st July 2026
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