Before a manufacturer can place a medical device on the European Economic Area (“EEA”) market or put the medical device into service, a conformity assessment must be performed with a positive result. Depending on the applicable conformity assessment procedure, a designated Notified Body must be involved in this procedure. Please note that putting medical devices on markets outside the EEA requires compliance with local medical device laws which are not subject to this Q&A.
List of Notified Bodies
In the Nando database of Notified Bodies on the website of the European Commission, one can find a list of certified Notified Bodies in the EU. In the Netherlands there are three Notified Bodies: DEKRA Certification, Kiwa Dare and BSI Group The Netherlands. However, please note that, even if you are located in the Netherlands, you can contact a Notified Body in another Member State without this having effect on the validity or scope of the declaration of conformity you hope to receive. That being said, not all Notified Bodies are accredited for all types of medical devices.
When to contact a Notified Body?
It is advisable not to wait too long before contacting a Notified Body. The waiting times for Notified Body services is, since the introduction of the MDR, notoriously long, partially because Notified Bodies themselves had to recertify under the MDR. Even though a Notified Body is not allowed to provide you with advise on your conformity assessment, it is very helpful to discuss your planning with them as soon as possible so you can make sure the Notified Body has sufficient recourses at the time you need their services.
How to contact a Notified Body?
A Notified Body can usually be contacted as you would contact any service provider, though their website, by e-mail or by phone. If you have hired a consultant to help you with the conformity assessment procedure, they may have contacts within a Notified Body already. However, please note that having contacts within a Notified Body does not mean you will be helped earlier. In addition, even though your consultant could have established contacts within a Notified Body already, another Notified Body might be a better fit for your company.
What does the process with a Notified Body typically look like?
Generally, the process looks as follows:
- Getting a spot on the Notified Body’s waiting list.
- Formal application to Notified Body: Submitting your product certification requirements and a part of your technical file.
- Receive Notified Body’s proposal: This proposal will form the basis of the contractual agreement with the Notified Body.
- Get a team and timeslot assigned after acceptance of the proposal.
- Assessment of technical documentation and QMS: During the review, the Notified Body will inspect the manufacturing site and audit the Quality Management System.
- Certification decision: Once the review of the technical documentation has been completed, all questions raised by the Notified Body reviewers have been answered, the factory inspection has been completed and the Quality Management System has been reviewed, the Notified body will, if positive, issue a certificate of conformity.
For the exact conformity process, you can ask for information to the Notified Body in question.