EU to Propose 1-year MDR Delay due to Coronavirus
Update Posted: 3rd April 2020
Medical device companies have been working to meet the implementation of the new MDR, scheduled for May 26, 2020. The European Commission is putting together a plan calling on the European Parliament and the Council in early April 2020 to postpone implementation of the current Medical Device Regulation (EU MDR) by one year considering the coronavirus pandemic. This measure is to reduce the burdens on the healthcare systems.
A one-year delay in the implementation of MDR will mark a significant shift in the EU strategy. This will ease the pressure from notified body authorities and the medical device industry and allow them to fully concentrate on urgent priorities related to the coronavirus crisis.
Despite the probable delay in MDR and IVDR implementations, most medical device manufacturers still have a lot to do in order to be ready when the transition does happen. The delay of date of application effects manufacturers of medical devices, notified bodies designated under current directives & old directives. Depending on where you are at with MDR remediation, our team can help you keep the momentum going. Celegence can provide gap analysis and cost-effective resourcing to ensure that you and your business are compliant with all of the EU MDR requirements.
Download the EU MDR checklist and let the spreadsheet identify gaps in your processes that need to be addressed to achieve MDR certification.