The European Commission is working on a proposal to delay enforcement of the EU Medical Device Regulation by one year, a spokesperson said Wednesday.
Policymakers are aiming to submit the proposal in early April, and are imploring the European Parliament and Council to quickly adopt the postponement ahead of the May 26 go-live date for the regulatory overhaul. “This will relieve pressure from national authorities and industry and it will allow them to focus fully on urgent priorities related to the coronavirus crisis,” EC spokesperson Stefan de Keersmaecker read in a statement.
The announcement was preceded by numerous calls to push back MDR’s previously unshakeable start date in light of challenges introduced by the ongoing COVID-19 pandemic, including from trade association MedTech Europe and from Socialists and Democrats (S&D) in Parliament.
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