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European Parliament Calls For Risk-Related Extensions Under MDR And IVDR

 
• By Amanda Maxwell

With the EU’s Employment, Social Policy and Consumer Affairs Council due to discuss solutions to the MDR crisis on 9 December, the European Parliament is calling for risk-related deferrals.  

stopping the Dominio effect
European Parliament Calls On Commission To Make Final Postponements To Medtech Regulations

The European Parliament’s committee on the environment, public health and food safety (ENVI) has told the European Commission to get on with adopting proposals to address problems with the implementation of the Medical Device Regulation (MDR) speedily - "given that a deferral is inevitable.”

Any delays proposed by the commission should be “linked to the risk class of devices in order not to endanger...

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More from Europe

International Reliance Gets UK MHRA OK In Drive For Agile Pre-Market Regulation – CE Marking Next

 
• By Ashley Yeo

UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.

Expert Panels Remain Tough On Manufacturers And Their Notified Bodies

 
• By Amanda Maxwell

The EU’s extra layer of checks on clinical evidence is proving a difficult, and sometimes humiliating process, for many device companies whose products have come under the spotlight.

Rising Oncology Start-ups Recognized For Breakthrough Cancer Research

 
• By Natasha Barrow

The Cancer Research Horizons Innovation Awards took place on July 10. Medtech Insight spoke to nominees for the women’s entrepreneur of the year award: Mireia Crispin-Ortuzar, CEO of 52 North Health; Anita Grigoriadis, CEO of PharosAI; and Maria Giovanna Lizio, Founder of WILD-Imaging Technology.

A Passport To Streamlined Medtech Access Under UK Life Sciences Plan

 
• By Ashley Yeo

An “NHS Innovator Passport” that allows quicker uptake of proven technologies across the national healthcare provider is one of the wins the UK government is looking to score from its new Life Sciences Sector plan. The plan majors on prevention. The medtech industry has given it a cautious welcome.

More from Geography

Abbott Lowers Outlook But Headwinds Are Temporary

 
• By Natasha Barrow

Despite headwinds, executives remain optimistic about growth in Abbott’s medical devices and diabetes divisions and plan several product rollouts, including the Volt PFA catheter for electrophysiology and the dual glucose-ketone sensor CGM.

A Passport To Streamlined Medtech Access Under UK Life Sciences Plan

 
• By Ashley Yeo

An “NHS Innovator Passport” that allows quicker uptake of proven technologies across the national healthcare provider is one of the wins the UK government is looking to score from its new Life Sciences Sector plan. The plan majors on prevention. The medtech industry has given it a cautious welcome.

Device Sterilization Plants Get Extra 2 Years To Comply On EtO Phase-Out

 
• By Elizabeth Orr

The exemption, which President Donald Trump announced on July 17, is intended to cut the risk of critical device shortages. Stakeholders say the technology needed to cut emissions to required levels is not yet widely available.