One year experience on EU Medical Devices Regulation (MDR) 2017/745 for single integral drug-device combination products

AdobeStock_278890190

Source: Adobe Stock

 Since 26 May 2021, Article 117 of the MDR asks for a notified body opinion (NBOp) to be included in the marketing authorisation applications (MAAs) for medicinal products that are a single integral drug-device combination…

 

How to read this journal article 

Thank you for visiting Regulatory Rapporteur. Journal articles are restricted to TOPRA members and registered users.

If you are a TOPRA member, or have already registered for limited free access, log in now (Option 1 below).

Not yet a member? You can either join TOPRA (Option 2 below) or register to view limited content for free (Option 3 below).

1. LOGIN

Already a TOPRA member?

Log in now using your MyTOPRA credentials, for unlimited access to all Regulatory Rapporteur journal articles, the online archive and latest industry news and podcasts.

Already registered for free content?

If you are not a TOPRA member but have already created an account to access limited free content, log in here using your registered user email and password.

Login

2. JOIN TOPRA

Interested in TOPRA membership?

Become a TOPRA member and join our global regulatory affairs community.

  • Great savings on our events and training.
  • Be part of our dynamic international community.
  • Contribute to the profession.
  • Grow your skills and knowledge.
  • Take your career to the next level.

Become a member

3. REGISTER FOR FREE

Want free access to selected content?

Register now to continue to access industry news, editorials and podcasts plus one member-only journal article each month.

  • Create your own library to save your favourite content.
Create a free account