EU Gives Final Thumbs Up To Altering Transition Deadlines For MDR Legacy Products

EU institutions have unanimously agreed to amendments to support the implementation of the Medical Device Regulation. The speed at which this has been done reflects the urgency of new measures to address the EU’s crisis.

closeup portrait of business people giving thumbs up - Image

The European Parliament has voted in favor of extending the transitional provisions for legacy products under the EU’s Medical Device Regulation, bringing the European Commission’s MDR amendment proposal one step closer to applying in EU law.

It has agreed to the text of the commission proposal for a Regulation which will not only extend deadlines for legacy products under the Medical Device Regulation, but also...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

More from Geography

India-UK Free Trade Agreement Sets Stage For Medtech Growth, But Industry Demands Safeguards

 
• By 

Announced after three years of negotiation, the FTA eliminates tariffs on 99% of Indian product types, covering nearly all trade value, and reduces tariffs on 90% of UK products. Although not yet formally signed, the deal is being positioned by the Indian government as “transformative,” with an estimated economic impact of $6.4bn for the UK alone by 2040.

Pathogen Sharing System Part Of Global Pandemic Agreement

 

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By 

The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.