Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Europe

Set Alert for Policy and Regulation - Europe

Medtech Biggest Casualty In Swiss/EU Uncertainty As Worst-Case Scenario Looms

Eighteen years of free trade threatens to come to a sudden stop, as a result of the stalemate in the market access agreement between Switzerland and the EU. Industry association Swiss Medtech is advising local medtech manufacturers to find notified bodies and authorized representatives based in the EU. However, local company SQS remains confident of its ongoing notified body role.

EU Switzerland Europe

Latest From Policy, Regulation & Europe

Device Week, 20 February 2020 – Industry Concerns Grow As Clock Is Running Out On EU MDR

With less than one hundred days left before the European Union Medical Device Regulations kick in, Medtech Insight’s executive editor Ashley Yeo and managing editor Amanda Maxwell discuss growing concerns by medtech industry members that they may not be ready in time to comply with these regulations and may inadvertently go afoul of the new regulations.

Device Week Regulation

All About Value – Brexit Aside, UK Industry Sees Good Things Ahead For Healthtech Adoption

ABHI director of value and access Luella Trickett talks about the importance of real-world evidence in product development and value-based procurement in secondary care in the UK.

United Kingdom Market Access

Will Switzerland’s Only EU Notified Body Survive Swixit Threat?

What will the fall-out of political tensions between the EU and Switzerland mean for notified bodies based in Switzerland, and for the future recognition of CE marks granted in one of the most important medtech markets in Europe?

Europe EU

Win For Axonics As England’s NICE Says Rechargeable Neuromodulation Is Cost-Effective

Health technology assessment body NICE is consulting on draft guidance that recommends Axonics' device for overactive bladder.

Health Technology Assessment United Kingdom

99 Days Until MDR: Time Is Running Out For Medtech As Risky, Volatile Future Looms

The last year of the run up to the full implementation of the MDR has been characterized by a flurry of new documents and measures, but industry is adamant that medtech is heading for a crisis that will impact industry and patients alike.

EU Europe

11 Notified Bodies Under MDR Now As Ireland’s NSAI Is Officially Designated

With just a few months remaining until the full application of the EU Medical Device Regulation, notified body designations are still only trickling through. Ireland is the latest EU member state to have a resident MDR notified body.

Europe EU
See All
UsernamePublicRestriction

Register