Digital Health In The EU: What Are The New Rules And Reimbursement Challenges?
Executive Summary
Digital health products are struggling gain traction in the EU in part due to an undefined regulatory situation and lack of funding structures. Now the scene is complicated by new EU regulations in medtech. Digital health products are struggling gain traction in the EU in part due to an undefined regulatory situation and lack of funding structures. Now the scene is complicated by new EU regulations in medtech. What should companies do? Paris-based attorney Alexandre Regniault discusses the situation with Medtech Insight.
You may also be interested in...
EU Regulatory Roundup, March 2024: Busy Agenda In Broad Range Of Key Areas
March was an important month for EU medtech regulation with an interesting spread of news relating to the Medical Device and IVD Regulations, the Batteries Regulation, the Artificial Intelligence Act and more.
EU’s Revised Phthalates Guideline Features New Annexes Focused On Alternatives
The effects of phthalates, plasticizers used in many medical devices, on the human endocrine system, have long been debated. But how safe are the alternatives? Updated guidelines give more insight.
Non-Medical Brain Stimulation Devices: Could They Be Down-Classified Again In the EU?
Six types of products that do not have an intended medical purpose fall under the scope of the Medical Device Regulation. Understanding their risks is complex and subject to regular re-examination by the European Commission.