Medtech Insight has already focused on six of the key changes in the parliament’s proposal to the European Commission. This article looks in further depth and breadth at the changes which, if taken up, are designed to ease the regulatory burden in the EU, support SMEs and innovation. and result in fewer products being removed from the market.
The scale of the changes in the European Parliament’s proposal for an amending legislation to the Medical Device Regulation to the European Commission is impressive and the result of large-scale, in-depth work.
The proposal, which reflects many of the points that have been raised over the last year by stakeholders, including industry...
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There is still no clarity on how life sciences will be treated in the final agreement.
NICE’s three-pronged lifecycle approach to healthtech evaluations includes late-stage assessments (LSA), which will be the focus of a short consultation in August.
In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.
Steve Bates, head of the UK BioIndustry Association, has been appointed executive chair of the government’s Office for Life Sciences as the UK restructures its life sciences approach and drives health outcomes with a new NHS Long-Term Care plan.
The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.
In his first 100 days as FDA commissioner, Martin Makary has gone from vocal critic to vocal supporter of the agency’s staff, calling them “phenomenal” and praising their dedication—even as morale remains shaken by recent layoffs and restructuring.
In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.
