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

Will Commission heed COCIR’s Comprehensive And Sometimes Radical Solutions To MDR Delays?

 
• By Amanda Maxwell

Industry’s timely compliance with the EU’s new medtech regulations is under threat. Will the European Commission consider potential solutions from COCIR as a persuasive factor for change?

Business Keyhole
Has COCIR Found the Elusive Solution to the MDR bottleneck problem?

It is the traditional summer break in Europe. But the volume of concerns being expressed by medtech players around the Medical Device Regulation’s 26 May 2024 compliance deadline is increasing.

The Hard Deadline

Manufacturers of medical devices and of many IVDs, including of new and legacy products, have a hard deadline of 26 May 2024 to comply with under the new EU Medical Device and IVD Regulations. Many are leaving compliance efforts so late that the size of the notified body bottlenecks will mean some will fail to be certified in time. Those that miss the cut-off will need to be removed from the market until they are declared compliant. That will be the case unless actions are taken by the commission to address this predicted scenario for many products.

Stakeholders are fearful that many products will remain uncertified under the new regulation’s still-tight timelines, often due to system failures...

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

UK’s Dementia Trials Accelerator Works To Fast-Track Trial Recruitment

 
• By Anabel Costa-Ferreira

A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.

Inaccurate Carbon Dioxide Readings Prompt Class I Recall Of Draeger Ventilation Filters

 
• By Brian Bossetta

Draeger Medical has recalled certain SafeStar and TwinStar ventilation filters after reports of serious injuries caused by misleading carbon dioxide readings.

UK MHRA Ready To Evolve Approach To In-House Manufactured Medtech

 
• By Ashley Yeo

The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.

FDA Changes Fail To Diminish US Appeal To European Medtech Industry

 
• By Amanda Maxwell

Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.

More from Geography

Inaccurate Carbon Dioxide Readings Prompt Class I Recall Of Draeger Ventilation Filters

 
• By Brian Bossetta

Draeger Medical has recalled certain SafeStar and TwinStar ventilation filters after reports of serious injuries caused by misleading carbon dioxide readings.

UK MHRA Ready To Evolve Approach To In-House Manufactured Medtech

 
• By Ashley Yeo

The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.

FDA Panel Supports Dermal Fillers For Décolletage Use

 
• By Elizabeth Orr

An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.