For medtechs facing the EU's original MDR May 2020 go-live date, a one-year delay announced in April to account for COVID-19’s burdens was mostly a blessing, but it didn't eliminate challenges of the regulation's complex implementation.
More proactive manufacturers in the lead-up to that deadline may have lost some competitive advantage to those that already lagged behind schedule.
But even with the last-minute delay, companies may be using the additional 12 months as some wiggle room to procrastinate. Faced with the impacts of COVID-19 and the subsequent European Commission decision to delay, some device companies “shifted into low gear for their MDR activities," said Paula Gray, an associate director in the life sciences practice at consulting firm Guidehouse.
Likewise, some companies used the newfound opportunity to get devices onto the market under the outgoing Medical Devices Directive. "I was actually very surprised at the number of people who were opting to get recertified under the
MDD in order to buy themselves some additional time to transition over to the MDR," Gray said.
Now that many medtechs' initial coronavirus efforts have progressed — getting a diagnostic test on the market, for example — Gray said more companies are re-engaging with their MDR projects. Those activities may include talking strategy, refining internal systems and processes, or just gaining a clearer understanding of certain postmarket surveillance requirements, unique device identification, clinical investigation and evaluation and what qualifies as a significant change.
Rather than scrambling to set up temporary infrastructure, "they now actually have the time to really sit down and think through the mechanics of the way the process should work the first time."