On 14 November 2016, the French National Agency for Medicines and Health Products Safety (“ANSM”) issued the English version of an information bulletin and a Q&A document concerning the consequences of de-notification or termination of notified bodies’ (“NB”) activities, dated 24 October 2016.
The ANSM notes that in recent months, several notified bodies have ceased their operations, either voluntarily or following a de-notification decision made by their European Union (“EU”) Member State’s competent authority. The de-notification of a notified body occurs either, when a competent authority suspends or withdraws the notified body’s authorization or, when the notified body decides not to renew its authorization.
Medical devices may only be placed on the market in the EU with a valid CE Certificate of Conformity and under regular monitoring by notified bodies. Related activities are the result of contractual relations between notified bodies and medical device manufacturers that are governed by private law.
As a result, neither EU nor French regulatory provisions specifically address the actions that must be taken with regards to CE Certificates of Conformity in the event that a designated notified body is de-notified or stops operating in this role.
The issue of the de-notification of notified bodies was raised at a meeting of the competent authorities of the EU Member States on 19 October 2016. At this meeting, competent authorities agreed on guidelines for managing such situations.
In the information bulletin the ANSM announced that, in line with these guidelines, it had established procedures for medical device manufacturers affected by the de-notification of a notified body and established in France.
The ANSM Procedures
The ANSM procedure provides that, under certain conditions, affected manufacturers may continue to market their medical devices in the European Union. The aim is to allow manufacturers some time to request and obtain new CE Certificates of Conformity from other valid notified bodies.
Manufacturers may apply to the ANSM for an extension of the marketing of their medical devices (“MD”) and in-vitro medical devices (“IVD”) on two conditions. Applicants must hold CE Certificates of Conformity the validity of which has not expired at the time of the application. The period of validity must in addition go beyond the date of the de-notification or end of operations of the notified body.
If the manufacturer’s CE Certificate of Conformity expires at a date prior to the de-notification or end of operations of the notified body, the manufacturer will not be allowed to benefit from this procedure.
The procedure provides that manufacturers must introduce an application as soon as possible and preferably within one month of the de-notification or end of operations of the notified body.
Manufacturers must submit several documents to demonstrate the continued safety of the concerned products:
- A list of the references for all MD/IVDs affected by the de-notification decision or the end of operations. The list should also specify the sales volume and the EU Member States in which they are being marketed and/or distributed;
- A copy of the most current version of the CE Certificates of Conformity identifying the MD/IVDs covered by these Certificates;
- A statement issued by the manufacturer certifying that its products continue to comply with fundamental requirements;
- Identification of the new notified body, evidence that the certification process has been initiated, and the anticipated date that it will be finalized.
During the evaluation of the application by the ANSM, manufacturers will be able to temporarily continue to market their MD/IVDs. The application will be approved only if the ANSM finds that, on the basis of the submitted documents, the products may continue to be placed on the market without risks concerning the safety of their use.
The extension is granted for a period of maximum 12 months following the notified body’s de-notification or effective end of activities. In the event that the CE Certificates of Conformity expire prior to the end of the 12 months period, the extension for marketing the products shall be allowed only for the remaining period of the Certificates’ validity.
Manufacturers must send the ANSM the audit report and the new CE Certificate of Conformity for the concerned MD/IVDs as soon as they are issued by the new notified body.
The ANSM will evaluate applications on a case-by-case basis for those CE Certificates of Conformity that relate to a medical device or in-vitro medical device that is essential or that has no existing alternative. The manufacturer is responsible for providing evidence of the essential nature of its MD/IVD.
For further information visit: http://ansm.sante.fr/var/ansm_site/storage/original/application/7fad82da57fe0f9df182fc5955b73d60.pdf and http://ansm.sante.fr/var/ansm_site/storage/original/application/206542f785ffaa12a6c1545b915fea3f.pdf