Denotification or termination of notified body activities
The situation may occur that a notified body (NB) is denotified (i.e a competent authority has suspended or withdrawn the NB’s authorization) or stops operation. The validity of previously issued CE certificates may be affected.
There are no specific provisions in both Dutch and European regulations regarding the future of CE certificates in case a notified body is denotified or stops operating. However the Dutch Healthcare and Youth Inspectorate (HYCI) is implementing a procedure for manufacturers/authorized representatives (AR’s) headquartered in The Netherlands. Guidelines for managing situations like this were agreed upon at the European Meeting of Competent Authorities (CAMD).
A Dutch manufacturer or AR may continue to market its medical devices (MD) and/or in vitro diagnostics (IVD) under certain conditions as long as they are covered by a valid CE certificate at the time of the application.
A formal application should be sent to email@example.com as soon as possible but within a month. The application should include:
- A list of references for all MD and / or IVD affected by the denotification. A copy of all current versions of the certificates and a specification of distribution and sales volume per member state in the last 36 months.
- A statement issued by the manufacturer certifying that its product continues to comply with fundamental requirements of a certified Quality Management System.
- Identification of the new notified body, evidence that the certification process has been initiated and the anticipated date that it will be finalized.
- A copy of the Post Marked Surveillance procedure (PMS), the most current PMS plan regarding all affected MD/IVD, a current version of the PMS report and the current version of the management review, specifically the parts that relate to vigilance and PMS.
- An overview of all incidents regarding the affected MD/IVD in the last 36 months, specified by countries worldwide.
- An overview of all initiated, ongoing or completed CAPA’s in response to incidents during the last 36 months (reason for initiating, possible root causes, conclusions and solutions).
The Inspectorate assesses whether the documentation and information provided by the manufacturer /AR demonstrates that the safety of the concerning MD/IVD is guaranteed and remains so during the notification process with another, new notified body.
Maximum of 12 months
MD/IVD with a valid certificate may continue to be marketed under curtain terms and conditions as mentioned here above and in all instances up to a maximum of 12 months. But never longer than the initial period of validity
Non compliance with the terms and conditions is subject to administrative measures by the Inspectorate.
Finally a positive audit report drafted by the new notified body should be sent to the Inspectorate as well as the new certificate. This will end the temporary supervision of the Inspectorate.
No new or modified products
The Inspectorate reiterates that it is not up to the competent authorities to replace notified bodies (NB) and take on their activities by virtue of amended directives 90/385/EEC, 93/42/EEG, 98/79/EG and the new MDR 2017/745 and IVDR 2017/246. This means that manufactures/AR’s are not allowed to purchase new or modified products.