EU MDR 2017/745 will reduce the Risk of Medical Devices. Does MDCG got it Right?

  • Vidya Sagar
  • Piyush Patel
  • Avni Rana
  • Bhavin Trivedi
  • Deepak Patel
  • Anil Kumar A

Abstract

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.

Keywords: EU MDR, PMS, European Database for Medical Devices (EUDAMED), Medical Device Directives (MDD), Post Market Surveillance (PMS), Risk Management

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References

1. The European Union Medical Device Regulation, 2017 [Internet]. 2017 [cited 2021 Oct 23]. Available from:
https://eumdr.com/risk-management-compared
2. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, (Text with EEA relevance). [Internet]. 2017 Apr 05 [cited 2021 Oct 22]. Available from:
https://eur-lex.europa.eu/eli/reg/2017/745/2017-05-05
3. Hans P. Zenner and Mijo Bozic. Clinical Evaluation of Medical Devices in Europe, Personalized Medicine in Healthcare Systems, Europeanization and Globalization 5. Switzerland: Springer Nature AG; 2019. https://doi.org/10.1007/978-3-030-16465-2_221
4. Josep Pane, Reynold D.C. Francisca, Katia M.C. Verhamme, Marcia Orozco, Hilde Viroux, Irene Rebollo, Miriam C.J.M. Sturkenboom. EU post market surveillance plans for medical devices. Pharmacoepidemiol Drug Saf. 2019; 28:1155-1165.
5. THE COMPLETE GUIDE TO EU-MDR TRANSITION, The FDA group, 2018 [Internet]. 2018 [cited 2021 Oct 23]. Available from:
https://www.thefdagroup.com/
6. ISO 14971:2019 Medical devices - Application of risk management to medical devices [Internet]. 2019 [cited 2021 Oct 26]. Available from:
https://www.iso.org/en/ics/11.040.01
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How to Cite
Sagar, V., P. Patel, A. Rana, B. Trivedi, D. Patel, and A. Kumar A. “EU MDR 2017/745 Will Reduce the Risk of Medical Devices. Does MDCG Got It Right?”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 4, Dec. 2021, pp. 33-36, doi:10.22270/ijdra.v9i4.497.