Denotification or termination of notified body activities
A manufacturer or European Authorised Representative (AR) may sometimes be confronted by the termination of a notified body designation. In other words, the notified body is no longer performing its tasks. This has consequences for the validity of certificates issued by the notified body. There is a difference between certificates issued under the MDR and IVDR and old certificates. The old certificates are still valid based on the transitional arrangement.
A notified body may stop performing its tasks for a variety of reasons. This can be voluntary if the notified body decides to terminate its activities voluntary. It is also possible that the member state in which the notified body is located has withdrawn the notified body designation. The notified body is then denotified by order of the Ministry of Health and removed from the NANDO database.
Denotification or termination has impact on the validity of already issued certificates. This is different for certificates under the old and new legislation.
MDR and IVDR certificates
The MDR and IVDR contain special provisions for the term of validity of these certificates. Certificates from notified bodies that have stopped performing their tasks are still valid for a maximum period of 9 months.
This is only possible if a written declaration has been issued by a new notified body which has taken over the tasks from the original notified body. This new notified body must carry out a full assessment within 9 months. A new certificate can only be issued if that condition is fulfilled.
Old certificates under the transitional provisions of Article 120 MDR & Article 110 IVDR
During the transitional period as defined in Article 120 of the MDR and Article 110 of the IVDR, certificates already issued under the MDD, AIMDD and IVDD will remain valid until the end of the period indicated on the certificate. The transitional provisions set out that the original notified body will remain responsible for the continued compliance with the requirements of the MDD, AIMDD and IVDD. The MDR and IVDR do not include any legal provisions in the event that the original notified body ceases its activities.
As regards the validity of these certificates in the event that the 'original' notified body ceases its activities, the following procedure applies as existed under the old legislation. This procedure is also applicable to IVDD certificates.
In the above-mentioned situation a Dutch manufacturer or AR can continue the marketing of medical devices and in vitro diagnostics for a limited period subject to certain conditions. This is only possible if these devices had a valid certificate at the time of the notified body denotification, or at the time at which the notified body in question terminated its tasks. When this period has ended a new notified body must have taken over the tasks in question and have certified the products.
As a manufacturer or AR you must fulfil the following conditions:
Inform the IGJ as soon as you know - or no later than within 4 weeks after the date of denotification/cessation of the activities of the notified body - via firstname.lastname@example.org how, in general terms, this affects you. When doing so you will provide an overview of all the certified medical devices/IVDs involved, as well as copies of the letter from the notified body in question which accompanied the most recent certificates and information about sales figures during the past 36 months, specified per member state.
The IGJ will register your notification and you will receive a confirmation of receipt and a reference number. After that you must submit the following documents within 4 weeks:
- A document in which you declare that the certified quality management system set up by you and by the notified body is being maintained until another notified body recertifies it.
- An overview of the measures which you have taken to switch to another notified body. This overview will contain, in any event, information about which notified body is going to take over the certification. You should add proof that the certification process has been started, including a prognosis of the lead time of this procedure and when the first audit is expected to take place.
- Documents describing the current post-market surveillance (PMS) procedure, the PMS plan of the medical devices involved, the most recent PMS report and management review, specifically the part relating to vigilance and PMS.
- An overview of all incidents involving the medical devices in question during the past 36 months (specified globally according to country and number of products sold).
- An overview of all initiated, ongoing or completed Corrective And Preventive Actions (CAPAs) as a result of incidents during the past 36 months (reason, possible fundamental causes, conclusions and solutions).
The documentation and information you submit must demonstrate that the safety of the medical devices and/or in vitro diagnostics in question is, and will remain, guaranteed during the notification process via another, new notified body. The IGJ will assess whether this is the case.
A maximum of 12 months
If the above-mentioned conditions are fulfilled, the manufacturer/AR can continue to market the medical devices and in vitro diagnostics for a maximum of 12 months, but never longer than the certificate's original period of validity.
If the conditions are not fulfilled, the IGJ will take measures and action against the marketing of the products involved.
The IGJ will terminate the temporary supervision after receiving a positive audit report and new certificates from a new notified body.
No new or changed products
The IGJ emphasises that it is not its task as a competent authority to take over the work and responsibilities of an notified body on the grounds of the MDR 2017/745 regulation, the 98/79/EC Directive and the IVDR 2017/246 which is coming into force in 2022. This means, for example, that manufacturers cannot start marketing any new products, or make changes to a product which require the assessment of a notified body.