Multi-stakeholder webinar to support implementation of the Medical Devices Regulation on drug-device combinations

This multi-stakeholder workshop is held in preparation for the changes introduced by Article 117 of Regulation (EU) 2017/745 on medical devices (MDR) for integral drug-device combinations (products falling under the second sub-paragraph of Article 1(8) and Article 1(9) of the Regulation.) These require notified bodies to be involved in the assessment of certain drug-device combinations from 26 May 2021.

For more information on the changes on drug-device combinations, see Medical devices: Medicinal products that include a medical device (‘combination products’).

The workshop will facilitate a discussion and an exchange of views and experience based on practical examples between European Union regulators, the European Commission, notified bodies, the pharmaceutical industry and medical-device manufacturers.

It will address, in particular:

• lessons learned from notified body opinion process thus far;
• lifecycle management, including ‘substantial design changes’.

There is limited capacity for verbal contributions during the webinar. EMA encourages interested participants to send questions ahead of the webinar.

EMA will address any unanswered questions in a forthcoming update of the  question and answers on implementation of MDR Article 117 .