Expert Insights: All you need to know about Notified Bodies

What role does a Notified Body have when applying the CE mark?

A Notified Body (NoBo) is a private company that is accredited by the European Commission to carry out assessments for medical devices higher than Class I. The NoBo will perform a conformity assessment to indicate whether the legal requirements for a particular product have been met. After assessing both the technical documentation and the quality management system, the NoBo can issue a certificate to indicate that the device is compliant with European legislation. The manufacturer can then use this certificate as a basis for their Declaration of Conformity, apply the CE mark, and bring the product onto the market.

How does one know whether they need a NoBo?

The classification of your medical device determines whether you require a Notified Body. Only Class I medical devices do not require a NoBo, meaning that Class I sterile (Is), Class reusable low risk non-invasive surgical medical devices (Ir), Class I with a measuring function (Im), Class IIa, Class IIb and Class III medical devices all require a Conformity Assessment Procedure by a Notified Body.

What are the most important things to consider when choosing a NoBo?

When choosing a NoBo, you should keep in mind three things: communication, compatibility and strategy. Effective communication with the contact person that you are appointed is crucial, so consider your preferred language when choosing a NoBo. Notified Bodies are established in different countries of the European Union, and while they generally operate in English, the country they are based in indicates what other languages they might offer services in. For example, if your company primarily communicates in German, it is best to choose a German NoBo.

Secondly, consider your compatibility with a Notified Body. The best known NoBo’s are the biggest companies, but that does not necessarily mean that they are the best choice for you. In fact, some manufacturers prefer a smaller NoBo over a larger, more renowned NoBo. Before choosing a NoBo, ask yourself some questions: how do you feel communication will go? Does their size and work method match your company’s workflow?

Being strategic when choosing a NoBo means thinking ahead to the cases in which you might need a NoBo and planning accordingly. For example, if your company has already contracted a Notified Body for the certification of your quality management system and you know you will need a NoBo to assess the technical documentation of your new products, it is beneficial to use the same NoBo. Thinking strategically can save you time and money in the certification process.

What is often overlooked by manufacturers when choosing an NoBo?

Medical devices range from band-aids to pacemakers, and there is a big difference between the assessment procedures for different medical devises. Often, Notified Bodies are accredited for specific types of medical devices. For example, some NoBo’s are only accredited for electrical medical devices. This means that not all NoBo’s may be eligible to carry out the conformity assessment for your device. Check out the European Commission’s NANDO list for a comprehensive list of all NoBo’s, as well as which medical devices they are accredited for.

Why will the number of NoBo’s decrease with the enforcement of the new MDR?

The Medical Device Regulation 2017/745 raises the standards for medical devices to meet EU requirements, meaning that the responsibilities for manufacturers and Notified Bodies change. Smaller Notified Bodies might not comply with all new requirements, which leads to their accreditation for medical devices being (temporarily) revoked. At the moment there are 11 Notified Bodies accredited within the European Union under the MDR. This number is due to increase as NoBo’s adjust to meet the requirements under the new regulation, but it is still a big change from the 70 that were accredited before the implementation of the MDR.

How will choosing a NoB ochange with the new MDR?

The process of choosing a NoBo will not change much for manufacturers since you still have the freedom to choose any NoBo (as long as they are accredited for your specific product). However, a new article in the MDR, Article 50, indicates that Notified Bodies are to make their standard fees available to the public. Increased transparency of fees can affect the decision-making processes for manufacturers.

Annemieke van Kerkwijk a medical device expert with years of MDD, MDR, QMS experience. Do you have questions about choosing a Notified Body, the new MDR or the classification of your Medical Device? Take up contact with our CE Medical experts today.