EU
The European Medicines Agency is set to adopt opinions on whether marketing approval should be granted to five new products, including three orphans. A decision is also due on a previously-rejected Alzheimer’s drug that was under re-examination.
“Four or five major acquisitions over the last few years repositioned it, a 140-year-old company, from being a B-to-B company to B-to B-to-C company. That is a major enterprise strategy shift,” says CEO Patrick Lockwood-Taylor.
Two lawyers within EU legal chamber Axon Lawyers created a Green Team to cope with the rise in EU Green Deal and related environmental sustainability and compliance needs for medtechs. One of them, Jilles van der Hoek, explains why manufacturers should be getting a jump on future requirements.
In an effort to streamline AI rules for high-risk systems and improve competitiveness, two European Parliament committees agreed amendments to the EU AI Act that will allow medtech companies to avoid double certification with notified bodies. A plenary vote takes place in late March.
The EU remains a major global player in biopharma but needs to act quickly or risk falling further behind its rivals, according to EFPIA.
The EU remains a major global player in biopharma but needs to act quickly or risk falling further behind its rivals, according to EFPIA.
Certain short-term EU market improvement measures are expected to be in place this month, said the European Commission, which has challenged device industry stakeholders for input and advice as the EU’s late-2025 bundle of device regulatory improvements begins to take shape.
US Trade Representative is taking two swings under Section 301(b) of the 1974 Trade Act. Customs and Border Protection has March 19 to provide US Court of International Trade with next update on its progress on providing refunds for IEEPA tariffs.
The public consultation on the European Commission’s proposed revision of the MDR and IVDR has been extended to accommodate late delivery of translated texts. EU notified bodies’ group TEAM-NB says the proposals need more balance to ensure the resulting regulations do not do more harm than good.
Regulatory uncertainty has affected business planning and funding opportunities for UK medtech companies, says Gerard Hanratty, head of health and life sciences at UK and Ireland law firm Browne Jacobson. On the other hand, the UK industry should not squander the opportunities it uniquely faces.
Petra Zoellner, regulatory affairs director at MedTech Europe, provides an update on the pace and direction of travel of recent European Commission proposals and actions for the EU medtech sector, while emphasizing the need for speed.
Legal procedures brought by Poland and Ireland could still force a rethink of controversial measures in the updated Urban Wastewater Treatment Directive, despite a recent legal setback for the pharmaceutical industry.