It comprises seven questions relating to the implementation of Article 117 of the new Medical Devices Ordinance. The following questions, for example, are addressed:

• What is Article 117 and what does it mean for medicinal products?
• When is my medicinal product considered to form an integral product with the administration device?
• How will the medical devices Regulation and in particular Article 117 impact new marketing authorisation applications?
• Will I need to provide a (new or updated) EU certificate / declaration of conformity / notified body opinion if there are changes to the device submitted through a variation / extension?

The EU directives have been in force since 25 May 2017 and replace - after a transitional period - the three directives 93/42/EEC, 98/79/EC and 90/385/EEC. The MDR will be fully operational in May 2020, while there is still time until May 2022 to fully implement the IVDR.

Further accompanying documents are planned and the Q&A document will also be continuously supplemented.

Sources:

Regulation (EU) 2017/745

Regulation (EU) 2017/746

EMA-News

Q&A-Dokument zur MDR und IVDR