By Robert Kerwin
Next Tuesday, May 26, 2020, was to be the effective date on which the new European Commission Medical Device Regulations (MDR) were to come into effect.
European medical device manufacturers, sellers and servicers were particularly interested in the implementation of the MDR pertaining to periodic safety reports and postmarket surveillance, as well as the new database of medical devices known as EUDAMED. Understandably, the pandemic has created a huge pause in everything, including MDR implementation. In recognition of the priorities related to the coronavirus crisis, the European Commission has postponed application of most of the MDR for one year.
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While the European Commission postponement, indeed, takes the immediate pressure to interpret and comply off of the national competent authorities, notified bodies, and manufacturers, all stakeholders are well advised to familiarize themselves with those sections of the MDR
that will impact their work.
Additionally, the Joint Implementation Plan released by the Medical Device Coordination Group (MDCG) in March 2020, prior to MDR postponement, will shed some further light
on some of the questions raised by the MDR.
MDCG was established to provide advice to the European Commission and to assist in ensuring, if possible, a harmonized implementation of the MDRs. The MDCG is chaired by a representative of the European Commission, and is composed of representatives of each of the member states, with industry stakeholders as observers. Though the Joint Plan is not, at this time, a European Commission officially approved document, where it was prepared by the MDCG with input from the national authorities, notified bodies, and industry observers, it does provide some of the road map of how MDR is likely to be implemented, and the challenges.
Periodic safety reports and postmarket surveillance reports
A short primer on the regulations requiring periodic safety reports and surveillance reports is appropriate. EU 2017/745 requires the manufacturers of medical devices to prepare
medical device periodic safety update reports (PSUR) and postmarket surveillance reports (PMSR) for medical devices. The new data required is likely to include existing baseline safety and performance information and the length of the marketing history or clinical experience with healthcare. PSURs have been a requirement in the pharma world. Depending upon the risk classification of the medical device, reports must be updated "when necessary", "every year", or "every two years".