What role does a Notified Body have when applying the CE mark?
MG: A Notified Body (NB) is a private company that is accredited by the European Commission to carry out assessments for medical devices higher than Class I. The NB 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 NB 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 NB?
MG: The classification of your medical device determines whether you require a Notified Body. Only Class I medical devices do not require a NB, meaning that Class I sterile, Class I with a measuring function, 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 NB?
MG: When choosing a NB, 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 NB. 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 NB.
Secondly, consider your compatibility with a Notified Body. The best known NBs 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 NB over a larger, more renowned NB. Before choosing a NB, 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 NB means thinking ahead to the cases in which you might need a NB 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 NB to assess the technical documentation of your new products, it is beneficial to use the same NB. Thinking strategically can save you time and money in the certification process.
What is often overlooked by manufacturers when choosing an NB?
MG: Medical devices range from band-aids to pacemakers, and there is a big difference between the assessment procedures for different MD’s. Often, Notified Bodies are accredited for specific types of medical devices. For example, some NBs are only accredited for electrical medical devices. This means that not all NB’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 NB’s, as well as which medical devices they are accredited for.
Why will the number of NBs decrease with the enforcement of the new MDR?
MG: 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 NBs 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 NB change with the new MDR?
MG: The process of choosing a NB will not change much for manufacturers since you still have the freedom to choose any NB (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.
Martin de Graaf is a medical device expert with more than 5 years of certification experience. Do you have questions about choosing a Notified Body, the new MDR or the classification of your MD? Take up contact with our CE Medical experts today.