IMed White Paper - THE PERFECT TIME TO PERFECT PMS
posted 6th March 2023
Deadlines for Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) implementation have been pushed once again, but many new or enhanced requirements under MDR are already enforceable, specifically those relating to improving patient safety such as PMS, PSUR, PMCF and the appointment of a PRRC -unless only selling legacy devices. To help medical device manufacturers make the best of the extra time, IMed Consultancy has identified and outlined best-practice concerning five critical activities:
- Engaging with patients and users
- Reviewing current publications in literature and trade channels
- Monitoring social media
- Monitoring competitor product safety performance
- Continually reassessing risk management data
Download your copy of the full report by clicking the image opposite.
Come and talk to us on stand 86 at Medical Technology UK 2023.