Digital Health Technologies: Where The Shift Is Needed In The EU To Increase Uptake
The market for the reimbursement of digital health technologies is being held back because of the current fragmentation in reimbursement and funding. MedTech Europe is calling for change.
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France Latest Country To Introduce Digital Medtech Reimbursement Fast-Track
France has introduced a fast-track market access pathway for certain digital health products, adding to similar schemes in neighboring EU countries Germany and Belgium. But how does the new reimbursement program work, and which products are eligible for coverage?
How And Where Tougher Clinical Evaluation Measures Under EU MDR Cause Challenges
A first of its kind study examines how large compared with medium companies are coping with the EU’s strict clinical evidence requirements. The results show how it is the more stringent demands for high-risk devices that are leading to device removals as well as market launch outside the EU.
Annex XVI Products Set To Have More Time To Comply With MDR
Devices without a clinical purpose that fall under the scope of the EU’s Medical Device Regulation need to be tightly regulated. Now it looks as though manufacturers will have more time to comply if they need it.