EURLs Go Live: A New Era For High-Risk IVDs

There is to be more rigorous testing from now on for high-risk IVDs. Measures are also in place to prevent device shortages during the transition to new rules.

Tube with red liquid labelled 'HBV', hepatitis B blood test concept.
Hepatitis Tests Are Among Those Now Subject To More Stringent EU Oversight

As of 1 October, EU reference laboratories (EURLs) must now conduct performance verification of high-risk IVDs as part of pre-market assessment and be involved in their batch release for four categories of Class D IVDs: hepatitis and retroviruses, herpes viruses, bacterial agents, and respiratory viruses that cause life-threatening diseases.

Five EURLs were designated last December to test these product categories with a start date of 1 October

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

More from Europe

Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector

 

While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.

Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

 
• By 

Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 

Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.

More from Geography

Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

 
• By 

Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.

FDA And Boston Scientific Face Legal Action Over Spinal Device Safety

 
• By 

A patient, Dena Lawler, is suing Boston Scientific and the US FDA over alleged harm from a spinal stimulator device. Lawler claims inadequate regulatory review allowed dangerous modifications to the device, which then caused her pain and other health issues. She is calling for reconsideration of the device approvals.

Tariff Pressures Creep Into Dexcom’s Margin Outlook Despite Domestic Manufacturing Shield

 
• By 

Dexcom’s relatively strong position amid tariff-related uncertainty is rooted in its long-standing investments in domestic manufacturing, but raw material inflation is driving cost concerns even in the face of operational efficiencies.