On 27 February 2019, the EMA published a question and answer document for the practical implementation of Regulation (EU) 2017/745 for medical devices (MDR) and Regulation (EU) 2017/746 for in vitro diagnostic medical devices (IVDR).
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.
Regulation (EU) 2017/745
Regulation (EU) 2017/746
Q&A-Dokument zur MDR und IVDR