Expert Analysis: EU Commission's Proposed Regulation On Health Technology Assessment

An HTA proposal from the European Commission represents a new step toward harmonized market access for health technologies in the EU. Simmons & Simmons lawyers Annabelle Bruyndonckx and Vladimir Murovec provide an expert view on the proposal, its impact on the medtech sector and how it relates to the EU Medical Device and IVD Regulations.

Concept of national healthcare system - EU - European Union
About The Authors

Annabelle Bruyndonckx is a counsel with Simmons & Simmons LLP, focusing on all parts of medicinal product and medical device lifecycles, from R&D and qualification, to marketing authorization/CE-marking, to pricing & reimbursement, manufacture and distribution, compliance, and more.

Vladimir Murovec is an associate with Simmons & Simmons LLP, advising on a wide range of regulatory issues relating to medicines, medical technologies and digital health solutions, including product qualification, (early) market access procedures, marketing, distribution, advertising, and monitoring of products.

On Jan. 31, the EU Commission published a proposal for a regulation (the "Draft Regulation") on health technology assessments (HTA; SWD[2018] 42 final) and amending a 2011 Cross-Border Healthcare Directive (CBD; 2011/24/EU). Also see "Revolutionary EU HTA Cooperation Proposal Will Use MDR/IVDR Platforms" - Medtech Insight, 1 February, 2018.

This draft HTA regulation builds on the collaboration and methodology pursued for more than 10 years by the

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 Regulation

Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.

HHS Suggests Drastic Reductions To Skin Substitute Payments

 
• By 

The US Department of Health and Human Services has proposed cutting Medicare reimbursement for skin substitutes used in chronic wound care by up to 90%. The change aims to address rising costs but could harm patient access and treatment quality, prompting concerns from industry stakeholders.

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

 
• By 

The 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

 

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.

More from Policy & Regulation

Injuries And Deaths Linked To Baxter Infusion Pump

 

The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.

Bates To Energize UK Office For Life Sciences

 
• By 

Steve Bates, head of the UK BioIndustry Association, has been appointed executive chair of the government’s Office for Life Sciences as the UK restructures its life sciences approach and drives health outcomes with a new NHS Long-Term Care plan.

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

 
• By 

The 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.