EU
With EU MDR/IVDR review proposals out, UK MHRA progress on a premarket regulation and, up ahead, a prospective consultation on accepting the CE marking indefinitely, now is a good time to assess EU-UK regulatory positions for the benefit of UK industry, says ABHI director Steve Lee.
Cardiovascular disease is moving to the top of the EU’s health agenda with the release of the Safe Hearts Plan, European Parliament scrutiny of which is expected at the end of Q1. Medical device companies applaud the initiative but will seek more input as the plan evolves.
Cardiovascular disease is moving to the top of the EU’s health agenda with the release of the Safe Hearts Plan, European Parliament scrutiny of which is expected at the end of Q1. Medical device companies applaud the initiative but will seek more input as the plan evolves.
The US pharmaceutical market is critical for European pharma companies, but new policies introduced by the Trump administration are creating an increasingly complex and uncertain environment for them.
An India-EU trade deal sets ground for a free trade agreement to lower tariffs on pharma, though an investment protection agreement – likely influencing data exclusivity – will be concluded later. Will the US now reconsider its India tariffs?
The European Medicines Agency is set to adopt opinions on whether marketing approval should be granted to five new products, including therapies for a serious liver disease and an ultra‑rare genetic mitochondrial disorder.
Two major EU trade agreements are on hold, with ramifications for the pharmaceutical market.
New compliance measures for big pharma under the amended EU sustainability reporting and due diligence directives could lead to new contractual requirements for smaller partners.
The UK MHRA will soon consult on allowing CE-marked devices indefinite access to the Great Britain market. Meanwhile, the EU has at last moved to make the MDR/IVDR more user friendly. Taylor Wessing partner Alison Dennis reflects on how these events could influence evolving UK medtech legislation.
As 2025 turns to 2026, Swiss medtechs are anxiously looking to the future on three major fronts, according to Daniel Delfosse, head of regulation and innovation at the national industry association, Swiss Medtech.
The version of the Critical Medicines Act adopted by a key committee of the European Parliament could mean uncertainty for the manufacturers of orphan drugs, warns industry.
The European Medicines Agency scheduled oral explanation meetings for Sanofi’s MS drug and two other products nearing the end of their EU regulatory review cycle. These meetings typically give companies a final chance to convince the agency their drugs merit approval.