EU MDR Delay is (nearly) Official
- Robert Bilkovski, MD
- Apr 17, 2020
- 2 min read
Ever since COVID-19 was declared by the WHO a global pandemic, medical device and in vitro diagnostics manufacturers were scrambling regarding MDR and IVDR readiness. COVID-19 has introduced significant impacts that affect product development timelines, including clinical trial execution and interactions with notified bodies.
The number of certified notified bodies has grown at a snails pace, that further challenges MDR (and IVDR) implementation. On March 25, 2020 the European Commission announced its intention to delay MDR implementation by one year. Moving the go-live date from May 2020 to May 2021. Today, MDR delay cleared a major hurdle in securing European Parliament approval. The Parliament vote of 693-1 (2 abstain) was compelling and now moves forward to securing approval by the member states. This news will provide relief to device manufacturers, given this time of uncertainty and afford an opportunity to refine and complete their MDR readiness activities.
Unfortunately, no further clarity has been rendered regarding delay of IVDR implementation, although many believe a one year delay is probable. Similar for IVD manufacturers, who are focusing their attention on providing solutions to address the COVID-19 pandemic, their attention for IVDR readiness may expose them to regulatory risk if IVDR regulation delay is not authorized. Therefore, it is essential to maintain focus on ensuring the technical file for each IVD will meet the General Safety and Performance Requirements (GSPR).
Central to meeting GSPR is to verify the scientific validity, analytical performance and clinical performance associated with each diagnostic test. IVD manufacturers should already be conducting performance gap assessments; if gaps are present, evidence plans should be designed and executed in the near future. Closure of the performance gap assessment culminates in the preparation of a performance evaluation report (PER) which includes the design of a post market performance follow-up (PMPF) plan.
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