275 Grove St., Suite 101C, Newton, MA 02466
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© 2000-2022. Parexel International Corporation.
275 Grove St., Suite 101C, Newton, MA 02466
+1 617 454 9300
2520 Meridian Parkway, Research Triangle Park, Suite 200, Durham, NC 27713
+1 919 544 3170
© 2000-2022. Parexel International Corporation.
BY Stephan Buttron, Principal Regulatory Affairs Consultant, Parexel - 11.13.19 -
With a three (3) year transition period, the European Medical Device Regulation (MDR) replaces the current Medical Device Directives from May 26, 2020 on. Article 120, however, allows legal device manufacturers continued market access of legacy devices with a valid Directives based CE-Mark certificate latest until May 26, 2024; but only within the regulatory framework of the new MDR Post-Market Surveillance (PMS) requirements becoming effective as of May 26, 2020.
Figure 1: MDR Transition Timelines for Medical Devices (Source BSI UK)
The main objective is to confirm continued patient safety, intended clinical performance and patient benefit(s) of the device throughout its expected lifetime.
The implementation of the PMS plan can result into two (2) different type of post-market reports based as outlined in Table 1:
[1] A National Competent Authority or Notified Body may request PMSR at any time.
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