1. Medtech Insight
  2. >>Geography
  3. >>Europe

EU Needs Feedback On Draft Requirements For Seven High-Risk IVD Test Categories

 
• By Amanda Maxwell

Two years after the EU adopted the original common specifications for certain products under the IVD Regulation, the commission has added new products and updated its requirements.

Zika Mosquito
Tests For Zika Virus Are Among Those Listed For Tighter Requirements

September 16 is the deadline for feedback on the European Commission’s text amending the 2022 implementing regulation that lays down common specifications (CS) for certain class D IVDs (the highest risk products) in the context of the IVD Regulation.

The updated proposed text outlines new detailed CS for detection of:

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
Start Free Trial

Already a subscriber?

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