Notified Bodies

What is a Notified Body (NB)?

A notified body (NB) is an organisation designated by a European Union (EU) member state (or other countries by specific agreements) to assess the conformity of certain products, including medical devices, before they are placed on the market.

Notified bodies provide an independent third-party review that helps maintain public trust in medical devices and ensures compliance with stringent regulatory standards.

Roles and responsibilities of notified bodies

A notified body assumes many responsibilities that a National Regulatory Authority (NRA) would generally oversee.

• Conformity Assessment: NBs conduct conformity assessments based on EU regulations, such as the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). They assess whether a medical device meets the required safety and performance standards before it can be marketed in the European Union.
• Certification: Upon successful assessment, NBs issue CE certificates. These certificates allow manufacturers to affix the CE marking to their products, indicating conformity with EU standards.
• Inspection and Audits: NBs conduct audits of the manufacturer’s quality management systems (QMS) to ensure ongoing compliance with regulations. Inspections may include reviewing technical documentation, processes, records and clinical evaluations.
• Post-Market Surveillance: NBs contribute to post-market surveillance by monitoring adverse events and device performance after the product has been placed on the market. They ensure that manufacturers comply with regulations and take corrective actions if necessary.

Designation and oversight

Notified bodies are designated by the national authorities of an EU member state (or another country under specific agreements). The designation process ensures that the notified body has the necessary expertise, resources, and impartiality to perform its duties. The designating authorities regularly assess notified bodies to ensure they maintain high standards and impartiality.

The European Commission publishes a list of notified bodies in the NANDO information system.

Selecting a notified body

Selecting a notified body is critical for medical device manufacturers aiming to place their products on the European market. It can be difficult to choose an NB, especially when there is high demand for their services (as is the case at the time of writing this post). MedDev Central has compiled a list of factors to consider when researching a potential NB partner.

Scope of Designation

The first step is to ensure the NB is designated for the specific medical device being developed and manufactured. Not all NBs cover all categories of medical devices. It is also important to check whether the NB has expertise in the relevant regulations. At present, 45 notified bodies have been designated. 33 NBs are designated under the MDR only, 10 NBs are designated under both the MDR and IVDR, and 2 NBs are designated under the IVDR only.

Experience and Competence

Assess the NB’s experience with similar products, including their history of certifications and any publicly available performance metrics. Verify the assessors’ technical expertise and familiarity with the device’s specific technologies and clinical applications. For example, some NBs lack the technical capacity to assess digital health technologies and would be unsuitable for a digital health tool manufacturer.

Capacity and Availability

Ensure the NB has sufficient resources to handle the project within the required timelines. Consider the NB’s lead times for initial assessments, audits, and reviews. Some NBs may have longer wait times due to high demand. This is particularly true at the present time, when some NBs are not accepting any new clients.

Geographic Location

While not always critical, having a notified body nearby can facilitate easier communication and potentially quicker on-site audits. Check whether the NB can provide services in all the geographies the company requires. Choose an NB that can operate in the preferred language and understands local regulatory nuances. If the business is multinational, it may be important to assess whether the notified body is recognised in all the locations that are important to the company. Verify any additional accreditations or certifications that may be relevant to your device and markets.

Cost

Evaluate the cost structure for the NB services. This includes initial assessment fees, annual audit fees, and any additional costs for specific tests or evaluations. Compare the costs with the services and expertise offered to ensure they offer value for money. NBs are expected to provide transparency on service pricing. However, this is not always the case and it can take some time to request quotes from each NB.

Reputation and Reliability

Research the NB’s reputation in the industry. Industry forums, peer recommendations, and customer testimonials. Ensure the NB is in good standing with its designating authority and has no significant regulatory or compliance issues. Conferences are a good place to research NBs. Ask other manufacturers about their experiences. Some regulatory consulting companies also track NB performance and make that data available through their newsletters or websites.

Service and Support

Assess the quality of customer service, including responsiveness, clarity of communication, and support during the certification process. Consider the level of support provided after certification, including assistance with post-market surveillance and ongoing compliance. A very common complaint of NBs is the lack of responsiveness. This has real-world implications as tardy communications can delay product approvals and certifications.

Audit and Inspection Approach

Understand the NB’s approach to audits and inspections, ensuring they are thorough but not unnecessarily burdensome. Check if the NB can accommodate specific needs, such as the timing of audits and handling non-conformities.

Conflict of Interest

Ensure the NB maintains impartiality and has no conflicts of interest that could compromise the assessment. The medical device world is a small one.

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