IVDR/MDR implementation – notified body publications

Posted on 01.12.2017

November has brought several publications of interest for the notified bodies launching the application process for designation under IVD or medical devices Regulation.

With the first implementing act envisaged under the Regulations published on 24 November in the Official Journal of the European Union, the Commission has drawn up the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of IVDs and medical devices. Notified bodies seeking designation under the new Regulations can submit their applications by filling in the forms that have been published recently on the website of the Notified Body Operations Group (NBOG).

The NBOG has also made available an updated version of its Best Practice Guide on designation and notification of conformity assessment bodies, providing more explicit information about how the designation will work in practice. It seems that the estimated time needed for a notified body designation is an average of 18 months, which puts into doubt the readily availability of the sufficient number of notified bodies to enable industry to meet the requirements of the new Regulations by the date of application. In addition, the Commission has also published an information note on joint assessments under the new Regulations, indicating its awareness of the challenges posed by the new regulatory regime and seeking to address some of the concerns regarding the Commission and the Member States capacity to deal with the new Regulations.

For more information please contact Oliver Bisazza, Director Regulations & Industrial Policy of MedTech Europe.

European Value-Based Procurement Conference

Join us for the 4th edition of the European Value-Based Procurement Conference which will be held on 15 December 2022.