European Regulatory Roundup, March 2022: Unprecedented Hiatus In Implementation Announcements

Unprecedented silence from the EU when it comes to news relating to the implementation of the Medical Device and IVD Regulations is disconcerting as compliance pressures mount.

Top Stories EU

The biggest news for March when it comes to the implementation of the Medical Device and IVD regulations is, in fact, the ongoing lack of news, prompting questions about whether this means the European Commission may be planning to take some decisive action that could result in an extension of timelines, for example, particularly for the MDR.

The French and German industry associations issued a position paper in mid-March calling for the grace period for MDR...

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

Innovative Wants Injunction Against J&J Subsidiary After $442M Antitrust Verdict

 
• By 

Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.

Liquid Biopsy Startup Mursla Bio Launches AI Precision Medicine Platform

 

The new AI Precision Medicine platform supports the company’s flagship product, EvoLiver, which received US FDA breakthrough device designation in April.

Prix Galien Spotlights Mental Health ‘Renaissance’ But Systemic Hurdles Persist

 

Experts at the Prix Galien UK Forum discussed the future of mental health innovation, emphasizing the important roles of digital solutions, diagnostic biomarkers and community involvement.