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EU Regulatory Roundup, July 2023: Weighing Up The Impact Of The MDR Amending Regulation

 
• By Amanda Maxwell and Ashley Yeo

July was a busy month for industry as the repercussions of the publication and enforcement on 20 March of the EU’s amending regulation to the Medical Device Regulation start to be really understood. 

Top Stories EU

Now, just over four months after the publication of the amending regulation to the MDR, which brought extended compliance timelines for legacy products, the real benefits and outstanding issues are really beginning to be understood.

Notably, during July, the European Commission published a survey showing the number of certificates granted by and applications made to...

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• By Natasha Barrow

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• By Ashley Yeo

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Ceryx Medical Amasses £11M To Develop Adaptive Cardiac Pacing Technology

 
• By Natasha Barrow

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European Medtechs Reiterate Opposition To Reciprocal Tariffs On US Imports

 
• By Ashley Yeo

EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.

Ceryx Medical Amasses £11M To Develop Adaptive Cardiac Pacing Technology

 
• By Natasha Barrow

The Development Bank of Wales and London-based Parkwalk Advisors led an investment round of £5m, almost doubling Ceryx Medical's total investment to date.

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

 
• By Elizabeth Orr

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.