Surveillance by the notified bodies is a condition that needs to be satisfied in order to make the manufacturer eligible for the extension in the transitional periods. Usually, the surveillance activities would be undertaken by the notified body that issued the CE certificate under the previous directives, as stated in Article 120 (3) the MDR. In cases where the manufacturer chooses to make use of the same notified body for conformity assessment under MDR, this would not raise any issues with regard to surveillance.
That being said, certain issues concerning surveillance arise when the manufacturer chooses to change notified bodies for MDR conformity assessment. The obvious question being, who will take over the responsibility of the surveillance? Would it be the outgoing notified body that issued the certificate, or the incoming notified body? Although the MDR states that it should be the outgoing notified body that issued the certificate, in certain cases, the manufacturer may opt to appoint the incoming notified body to be responsible for the surveillance activities.
In such cases, as stated in the Q&A issued by the commission, this transfer of responsibility should be detailed in a tri-partite agreement between the incoming and outgoing notified bodies and the manufacturer. Due to this, Team Notified Body has issued a position paper in which they detail the specific terms of the transfer of the appropriate surveillance activities according to Article 120 (3e) of the MDR.
The document can be accessed using the following link
