EU HTA Regulation: ‘Another Layer Of Bureaucracy For Medtech To Overcome’
MedTech Europe is “highly skeptical” about the added value of the forthcoming EU Regulation on Health Technology Assessment for health systems and citizens and explained to Medtech Insight how it currently fails medtech.
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The EU is on the cusp of a new era for HTA with a new regulation and new structures falling into place. The medtech industry’s concerns have not been addressed, but it hopes for changes ahead.
The regulation of medicines and medical devices have long worked along parallel, but very different, lines. Now there is increasing pressure for them to also be jointly improved to support innovation.
After three and a half years of negotiations, the EU is on the point of formalizing its agreement on closer collaboration between member states on health technology assessment.