EU MDR finally goes into effect

The E.U.’s Medical Device Regulation (MDR) takes effect tomorrow, changing the process to gain entry to the continental market.

EU MDR replaces the EU Medical Device Directive (MDD) with more stringent requirements on the companies that perform the audits for each device, also known as notified bodies. The change affects not only devices that are new to the EU market but those that entered the market under MDD and must be re-certified under MDR to remain available for sale — a costly and time-consuming process.

The effects of the COVID-19 pandemic convinced the European Parliament to vote in April 2020 to postpone the original EU MDR deadline by one year. But the parliament held fast to the May 26, 2025, final transition date to the new system

Major medtech companies that produce numerous devices will continue to work through their product portfolios to determine which devices make financial sense to transition to MDR by the 2025 deadline. Manufacturers of in vitro diagnostics still have one more year to prepare for the EU’s in vitro device regulation (IVDR).

Here’s a look back at some of the EU MDR issues we’ve covered:

• EU issues MDR factsheet for Class I medical device manufacturers

• EU allows remote audits for medical devices during pandemic

• How major medtech companies are responding to the looming EU MDR

• CE Mark approvals soared pre-EU MDR deadline

• European Commission to ask for EU MDR enforcement delay

• How EU MDR will affect labeling on small medical devices

• Getting the most out of your lab partnership ahead of the EU’s MDR

• European Commission publishes guidance on responsible person requirements under MDR, IVDR

• What you need to know about reusable devices and Europe’s MDR