The European Medicines Agency (EMA) has released its first set of Q&A Guidance Notes regarding the implementation of the Medical Devices Regulation (EU) 2017/745 (MDR), and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).
These regulations come into force on 26th May 2020 and 26th May 2022 respectively and, despite MedTech Europe’s concerns about the slow implementation of these Regulations, the EMA have not yet acceded to requests for extensions to the transition periods.
The first set of Q&A Guidance Notes concentrate upon the implementation of Article 117 MDR, which introduces a new requirement for notified body involvement in a medicinal product with an integral medical device. The document discusses:
- When is my medicinal product considered to form an integral product with the administration device?
- How will the MDR and in particular Article 177 impact new Marketing Authorisation Applications (MAA)?
- When is it required to provide the notified body opinion / EU certificate / declaration of conformity with my Marketing Authorisation Application (MAA)?
- At what stage do I need to submit the notified body opinion?
- How does Article 177 MDR impact currently authorised medicinal products with an integral medical device?
- 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?