Europe – European Commission updates on MDR, IVDR implementation timeline

The European Commission this week updated its “rolling plan” for adopting implementing acts and other measures ahead of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
 
The update follows the move to delay the implementation of MDR by one year due to the coronavirus disease (COVID-19) pandemic and the decision to delay Eudamed’s rollout by two years last December. (RELATED: MDR delay official as industry calls to push back IVDRRegulatory Focus 24 April 2020; Eudamed’s 2-year delay: CAMD executive group calls for interim solutionsRegulatory Focus 2 December 2019).
 
Implementing acts and other activities
 
The rolling plan lists several upcoming implementing acts concerning the reprocessing of single-use devices; specifications for devices without a medical purpose; the designation of expert laboratories; designations and rules pertaining to EU reference laboratories for in vitro diagnostics (IVDs); Eudamed support and maintenance; and common specifications for high risk (Class D) diagnostics…