Dharti Shah
Dharti Shah is Regulatory Affairs Specialist, HCL Technologies ERS, Mumbai.
JournalEU MDR implementation – what is changing for the medical device industry?
This article focuses on the impact of the Medical Device Regulation (MDR) transition extension period and provides guidance for medical device manufacturers on the new Regulation (EU) 2023/607. MDR (EU) 2017/745 came into force in May 2017 and became applicable in May 2020. After multiple amendments to the MDR, the ...
FocusPractical insights into the recent EU MDR framework
This article focuses on the impact of the new guidance document on drug-device combination (DDC) products, in Article 117 of the European Medical Device Regulation (MDR) for pharmaceutical marketing authorisation holders (MAHs). It explores the new role of the notified body (NB) versus the MAH pertaining to the device part of the DDC, some of the pitfalls encountered by pharmaceutical MAHs and potential solutions to efficiently navigate the new framework. It also provides practical insights into key technical requirements for the product-specific quality aspects of a medical device, which are within the quality dossier of a successful EU application. The article also explores efficient global implementation within fast evolving and at times divergent, regional regulations.