Regulatory
Above and beyond
Similarly, transition to full IVDR compliance has been rescheduled according to the classification of the device, with Class A and new devices requiring full compliance from May 2022, and a gradual deadline for devices already on the market that are Class D (May 2025), Class C (May 2026), Class B and Class A Sterile (May 2027).
E 14
xtensions under MDR are to the end of 2027 for high-risk devices and to the end of 2028 for medium and certain lower risk devices.
compliance
As 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 back once more, manufacturers are increasingly feeling inclined to procrastinate on a number of MDR compliance activities. Leeanne Baker, managing director and quality and regulatory consultant at IMed Consultancy, explains why medical device manufacturers need to be proactive, and how doing so could benefit their core business outside of meeting regulatory requirements.
A number of new or enhanced requirements under MDR are, however, already enforceable. Among these are the following, which are closely related to patient safety: Post Market Surveillance (PMS); Periodic Safety Update Report (PSUR); Post-Market Clinical Follow-up (PMCF); and Person Responsible for Regulatory Compliance (PRRC). For PRRC, it should be noted that the requirements do not apply for those only selling legacy devices – those already on the market with a valid certificate from the Medical
Medical Device Developments /
www.nsmedicaldevices.com
Panchenko Vladimir/
Shutterstock.com
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