European Medicines Agency, Oct. 2019 / Update
1. Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)
2. Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) - tracked changes. This update of the questions and answers focuses on aspects relating to the implementation and applicability of the requirements of Regulation (EU) 2017/745 to medicinal products with an integral or co-packaged medical device.
This Question and Answer (Q&A) document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations. This document has been produced to provide guidance to Applicants as regards aspects falling within the scope of the Agency’s activities and should be read in conjunction with the new medical devices Regulation (EU) 2017/745, and the new in vitro diagnostic medical devices Regulation (EU) 2017/746.
The Regulations entered into force on 25 May 2017; however, they will have a transition period to allow manufacturers, notified bodies and authorities to comply with the changes and will come into full application on 26 May 2020 (postponed at 26 May 2021 from Regulation (EU) 2020/561) for medical devices and 26 May 2022 for in vitro diagnostics.
These regulations lay down roles and responsibilities for EMA and National Competent Authorities (NCA) for medicinal products, as follows:
This is a living document and the questions and answers are being updated continuously, and will be marked by “NEW” or “Rev.” with the relevant date upon publication.
Table of contents
1. Medicinal product medical device combinations (‘combination products’)
1.1. What regulatory framework does a product incorporating both medicinal product and medical device fall under? New Oct 2019
1.2. How do I choose a notified body for my co-packaged /integral device? New Oct 2019
2. Medicinal product with an integral medical device (integral DDC)
2.1. When is my medicinal product considered to form an integral product with the administration device?
2.2. What is Article 117 and what does it mean for medicinal products? Rev. Oct 2019
2.3. How will the medical devices Regulation and in particular Article 117 impact new marketing authorisation applications? Rev. Oct 2019
2.4. When is it required to provide the notified body opinion/ EU certificate / declaration of conformity with my Marketing Authorisation Application (MAA)? Rev. Oct 2019
2.5. At what stage do I need to submit the notified body opinion?
2.6. How does Article 117 of the medical devices regulation impact currently authorised integral DDCs? Rev. Oct 2019
2.7. 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?
2.8. What is the impact of the MDR on medicinal products including an integral medical device for a Mutual Recognition Procedure submitted on or after the 26 May 2020? New Oct 2019.
2.9. Are the requirements for UDI (unique device identifier) applicable to integral DDCs? New Oct 2019
3. Medicinal product with a co-packaged device
3.1. How will the implementation of the Medical Device Regulation affect the device? New Oct 2019