February 28, 2023

EU MDR PMCF Plan is Needed for Legacy Devices

In order for an EU MDR Article 120 “legacy” device (as defined in MDCG 2021-25) MDD certificate to remain valid, certain conditions upon which issuance of that legacy MDD certificate was based shall be maintained regardless of whether devices have yet been placed on the market.  For example, even if the legacy device was never before placed on the market, Annex III still requires a PMS Plan and, where not eligible for the EU MDR’s general PMCF waiver opportunity, a PMCF Plan, as a condition for maintenance of the validity of the legacy MDD certificate.  In other words, said PMCF Plan (and overarching PMS Plan) is generally required to be drawn up and ready for execution as a condition of maintaining the validity of the legacy MDD certificate.  Again this remains the case even if the legacy device hasn’t yet been placed on the market.

Note also that it is my understanding that, as a general rule, the planned/required PSUR shall also be drawn up at the required time.  If, at such time, no devices were yet placed on the market, then the PSUR simply states in the corresponding sections that there are yet no PMS / PMCF data collected for the marketing of the subject device because no subject devices have yet been placed on the market.

However, be aware that part of the PMS plan upon which the legacy MDD certificate is contingent requires collection and analysis of PMS data not just on the marketing of the subject device.  Specifically, the PMS plan also requires collection and analysis of data from specialist or technical literature, databases and/or registers, and publicly available information about similar medical devices.  Accordingly, be sure you have suitably addressed those required PMS aspects even if you haven’t yet marketed the subject device.