EMA Released MDR Guidance which Addresses Transitional Provisions

09 October 2019

GMP News

The European Commission’s Medical Device Coordination Group (MDCG) released guidance to further explain Article 120(2) of the EU Medical Devices Regulation (MDR), which says that certificates issued in accordance with the previous device directives will remain valid until 27 May 2024.

The MDCG notes that Article 120(3) of MDR establishes that the notified body that issued a device certificate continues to be responsible for the appropriate device surveillance activities.

“It has to be noted that, as reported in FAQ n.17 of the MDR transitional provision document published by the CAMD Transition Sub Group, the contract between the manufacturer and the notified body who issued the certificate under the relevant Directive shall include provisions allowing the appropriate performance of such surveillance activities,”

the guidance says.

In order to allow manufacturers to take advantage of Art. 120(2) and Art. 120(3) of MDR, it needs to be ensured that national authorities responsible for notified bodies “have the right to and do monitor those notified body’s activities to the extent appropriate and necessary,” the guidance says.

But the guidance notes that whether a notified body has applied or not to be designated under MDR does not matter under these circumstances.

“For this purpose, Article 120(3) and Article 122(1) of the MDR provide the necessary legal basis for the Member States to establish the necessary legal empowerments by means of National law to carry out the needed monitoring activities in relation to Notified Bodies,” - the guidance says.

The Medical Device Coordination Group also notes that any notified body notification published in NANDO in accordance with the directives will be voided beginning 26 May 2020, when Medical Devices Regulation takes effect.

“Therefore, NANDO will only be used in relation to the Directives for information purposes after 25 May 2020. NANDO will, therefore, list those notified bodies that have been designated under the Directives with a clear message that they are not able to issue new certificates but only allowed to carry out surveillance activities for valid certificates in the transitional period, as established in Article 120 of the MDR,” - the MDCG says.

Source

Print

Shareholders

Read more

Pipeline

Read more

Media Center

Read more