1. Medtech Insight
  2. >>Geography

Premarket Innovators And SMEs (Part 1): How Many Will Survive EU MDR?

How delays in EU MDR compliance now threaten the lifeblood of the medtech industry

 
• By Amanda Maxwell

The EU Medical Device Regulation threatens the viability of many premarket innovators and SMEs in the UK, and across Europe. Eithne Lee, of ISO Life Sciences global consultancy, explains how the new requirements come as a shock for many small companies, how many are ill-prepared and how the cost of compliance relative to turnover may be too high. This is part one of a two-part article.

Tightrope

The EU Medical Device Regulation (MDR) has a disproportionate impact on premarket innovators and SMEs, because while they need to meet the full requirements of the MDR, they have fewer resources to do so. And many are still not sufficiently aware of the urgency of meeting these requirements and what this involves, even at this very late stage, Eithne Lee, director at London-based ISO Life Sciences global consultancy, warned during a recent interview with Medtech Insight.

This is in contrast to the multinationals who are innovating and who have the in-house resources to project-plan their work in the context of the new regulation.

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

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
• By Amanda Maxwell

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By Ashley Yeo

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.

More from Geography

Guardant Health Launches Germline Hereditary Cancer Test

 
• By Natasha Barrow

Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.

Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 
• By Natasha Barrow

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.