Why The European Pharmaceutical Strategy Matters So Much For The Devices Sector
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.
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The EU could be on the point of serious disruption to the regulation of products that combine devices and drugs. The extent of EMA involvement is creating nervousness in the devices industry. In what direction are EU rules headed?
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.
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.