Open AccessEU MDR 2017/745 will reduce the Risk of Medical Devices. Does MDCG got it Right?
Author(s) -
Vidya Sagar,
Piyush M. Patel,
Avni Rana,
Bhavin Trivedi,
Deepak Patel,
Anil Kumar A
Publication year - 2021
Publication title -
international journal of drug regulatory affairs
Language(s) - English
Resource type - Journals
eISSN - 2321-7162
pISSN - 2321-6794
DOI - 10.22270/ijdra.v9i4.497
Subject(s) - obligation , european union , business , possession (linguistics) , risk management , member states , european market , medical device , operations management , medical emergency , medicine , political science , engineering , law , finance , economic policy , international trade , linguistics , philosophy , biomedical engineering
Under the new European Union Medical Device Regulation (EU MDR), framed by Medical Device Coordination Group (MDCG), for each device manufacturers must have a documented risk management plan, identify and analyse the known and foreseeable hazards, estimate and evaluate the associated risks and eliminate or control those risks. In contrast with the MDD, the new EU MDR contains an explicit obligation in the new Article 10 (2), that manufacturers establish, document, implement and maintain a system for risk management. The detailed requirements of which are listed in the new Annex I Chapter I.
Compared to MDD there is more emphasis on Post Market Surveillance (PMS) activities with the inclusion of European Databank or European Database for Medical Devices (EUDAMED) and mandatory submission of Periodic Safety Update Report (PSUR) to all the actors in the possession with the medical devices.
A poll conducted by Aegis Lifesciences Pvt. Ltd, Ahmedabad, India concludes that the relevant annexures and sections in MDR 2017/745 have more emphasis on PMS, Vigilance, PSUR, EUDAMED, tracking, Implantation card etc. that are directed in regard to the safety of the Medical Device.