EU Parliament Urges Revision of MDR and IVDR

The European Parliament has published the adopted text of a resolution entitled ‘Urgent need to revise the medical devices regulation.’ This resolution pertains to MDR Regulation (EU) 2017/745 and IVDR Regulation (EU) 2017/746. The EU Parliament calls on the Commission to propose solutions by Q1 2025, within 100 days of the next Commission mandate. 

While the MDR and IVDR were introduced to strengthen regulatory requirements for medical devices, delays have occurred in the certification and approval processes for the EU market. This resolution acknowledges evolving medical needs and emphasizes the importance of encouraging innovation in medical devices while ensuring patient safety.

Main Takeaways from the Resolution

The resolution requests the following: 

• • Creation of transparent and binding timelines for regulatory reviews 

• • Clarification of the regulations to reduce interpretation, which will help eliminate unnecessary administrative burden 

• • Increased transparency in Notified Bodies fees 

• • Support for SMEs facing challenges in implementing MDR/IVDR 

• • Prioritization and fast-tracking of breakthrough devices addressing unmet medical needs 

• • Elimination of unnecessary re-certification of products 

• • Establishment of a clear definition for ‘orphan device’ and the introduction of adapted rules for orphan and pediatric medical devices 

• • Protection of user health and user data collected by e-health applications 

• • Urgent full implementation of EUDAMED 

Response from EU Member States

Several EU countries, including Ireland, Germany, Slovenia, Portugal, France, Spain, Finland, Sweden, Belgium, Denmark, and the Netherlands, have responded. The Competent Authorities in these countries have expressed openness to new proposals. However, they note that the timeline may not allow sufficient time to carefully consider expedited policy and legislation. 

To read the full article, click here. 

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