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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

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