Notified Bodies for Medical Devices: What You Need to Know
For medical device manufacturers planning to sell products in the European Union, understanding Notified Bodies for medical devices is an important part of the CE marking process. A Notified Body is an organization designated by an EU Member State to perform specific conformity assessment activities under applicable European legislation.
Depending on the device classification, intended purpose, and conformity assessment route, a manufacturer may need a Notified Body to review its quality management system, technical documentation, clinical evidence, or other regulatory requirements before the device can be placed on the EU market.
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What Is a Notified Body for Medical Devices?
A Notified Body for medical devices is an organization designated by an EU Member State and notified to the European Commission to perform conformity assessment activities under regulations such as the EU Medical Device Regulation (EU MDR) 2017/745.
Notified Bodies assess whether applicable medical devices and manufacturers meet the requirements of the EU MDR. Their activities can include:
- Auditing the manufacturer’s quality management system
- Reviewing technical documentation
- Assessing clinical evidence and related documentation
- Evaluating conformity with applicable MDR requirements
- Conducting surveillance audits
- Issuing applicable certificates following successful conformity assessment
It is important to understand that a Notified Body does not simply “approve” every medical device. Its role depends on the conformity assessment procedure applicable to the device.
Do All Medical Devices Need a Notified Body?
No. Whether a Notified Body is required depends largely on the device classification and the applicable conformity assessment procedure.
Under the EU MDR, medical devices are generally classified as Class I, Class IIa, Class IIb, or Class III. Class I devices may qualify for manufacturer self-declaration when they are not sterile, do not have a measuring function, and are not reusable surgical instruments.
However, certain Class I devices, such as:
- Class Is – sterile devices
- Class Im – measuring devices
- Class Ir – reusable surgical instruments
require Notified Body involvement for the applicable aspects of conformity assessment.
Class IIa, Class IIb, and Class III medical devices generally require Notified Body involvement before CE marking can be completed.
Manufacturers should therefore determine the correct classification before selecting a conformity assessment route.
For a deeper understanding of classification, see our guide on medical device classification under EU MDR.
What Does a Notified Body Do?
The exact activities depend on the device and conformity assessment procedure. Common responsibilities include:
1. Quality Management System Assessment
A Notified Body may audit the manufacturer’s QMS to determine whether it meets applicable regulatory requirements. For many manufacturers, ISO 13485 certification is an important part of establishing an effective medical device quality system.
Operon Strategist supports manufacturers with ISO 13485 Quality Management System implementation, documentation, gap assessment, and regulatory compliance.
2. Technical Documentation Review
Manufacturers must prepare technical documentation demonstrating that their device meets applicable EU MDR requirements.
Depending on the device, documentation can include:
- Device description and specifications
- Intended purpose
- Design and manufacturing information
- Risk management documentation
- Clinical evaluation
- Verification and validation data
- Labeling and instructions for use
- Post-market surveillance documentation
Our guide on what Notified Bodies look for in EU MDR technical documentation provides additional guidance.
3. Clinical and Regulatory Evidence Assessment
Notified Bodies may assess whether the manufacturer’s clinical evaluation and supporting evidence adequately demonstrate the safety and performance of the device.
Manufacturers should ensure that clinical, technical, and risk management documentation is consistent and supports the device’s intended purpose and claims.
4. Surveillance and Ongoing Compliance
Conformity assessment does not necessarily end once certification is obtained. Depending on the applicable route, Notified Bodies may conduct surveillance activities to verify continued compliance.
Manufacturers must also maintain their QMS, update technical documentation when necessary, monitor device performance, and fulfill applicable post-market surveillance and vigilance obligations.
Learn more about post-market surveillance for medical devices.
How to Choose the Right Notified Body
Selecting the appropriate Notified Body is an important strategic decision. Manufacturers should consider:
1. MDR designation and scope:
Verify that the organization is designated under EU MDR 2017/745 and covers the relevant device categories and conformity assessment activities.
2. Technical expertise:
Consider whether the Notified Body has experience with your device technology, classification, and intended purpose.
3. Capacity and availability:
Notified Body capacity can affect project timelines. Manufacturers should discuss expected review and audit schedules early.
4. Conformity assessment route:
Understand which assessment activities will apply to your device and whether the Notified Body can support the required route.
5. Communication and planning:
Clear communication about documentation, audits, timelines, and regulatory expectations can help reduce avoidable delays.
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Common Challenges With Notified Bodies
Medical device manufacturers may face several challenges during the conformity assessment process, including:
- Selecting a Notified Body with the appropriate scope
- Preparing complete technical documentation
- Identifying gaps before the formal assessment
- Addressing non-conformities
- Maintaining consistency between clinical, technical, risk, and QMS documentation
- Managing regulatory changes and post-market obligations
Early preparation can reduce the risk of repeated reviews and project delays.
How Operon Strategist Can Help
Choosing and working with a Notified Body is only one part of achieving EU market access. Manufacturers also need a clear regulatory strategy, appropriate classification, compliant technical documentation, an effective QMS, and evidence supporting safety and performance.
Operon Strategist provides medical device regulatory consulting and compliance support for manufacturers entering global markets. Our EU regulatory services include:
- CE Marking under EU MDR and IVDR
- ISO 13485 Quality Management System support
- EU MDR regulatory strategy
- Technical documentation and regulatory documentation support
- Medical device classification
- Regulatory gap assessment
- Notified Body selection and coordination
- Post-market regulatory support
We help medical device manufacturers plan their regulatory pathway, prepare documentation, identify compliance gaps, and coordinate key regulatory activities.
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FAQ's
What is a Notified Body for medical devices?
A Notified Body is an organization designated by an EU Member State to perform specified conformity assessment activities for products regulated under legislation such as the EU MDR.
Is a Notified Body required for Class I medical devices?
Not always. Certain Class I devices can use self-declaration, while Class Is, Class Im, and Class Ir devices require Notified Body involvement for the applicable conformity assessment requirements.
Do Class II and Class III medical devices need a Notified Body?
Generally, yes. Class IIa, Class IIb, and Class III devices require an applicable conformity assessment involving a Notified Body before CE marking.
How do I select a Notified Body?
Manufacturers should check the Notified Body’s MDR designation, scope, technical competence, conformity assessment capabilities, availability, and experience with similar devices.