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Europe

Set Alert for Policy and Regulation - Europe

Harmonization On The Mind: UK MHRA Wants Major Role In Global Regulation

Regardless of the path that the UK-EU Brexit negotiations take, the UK MHRA and the bulk of the local medtech industry are very clear on one thing: The need to retain access to the nascent EU Medical Device and IVD Regulations – and with it, EU reciprocity on device regulation. Any alternative approach is likely to engender unfathomable difficulties and disadvantage for the homegrown UK medtech industry, stakeholders say.

United Kingdom Regulation Brexit
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Latest From Europe, Policy & Regulation

EU Commission May Open Floodgates By Inviting Input On Editorial Errors

The European Commission is planning to invite comments on editorial mistakes within the EU's new medtech regulations. But will it get more than it is bargaining for?

Europe Medical Device

Crucial EU Meeting Oct. 18 To Set Out MDR/IVDR Implementation Work

Implementation of the EU's new highly-detailed Medical Device and IVD Regulations will greatly challenge EU regulatory groups. The work plan signposts the direction ahead, but it will be resource-hungry.

Medical Device Europe

UK IVD Industry Finds New Voice And Appetite For Challenges Ahead

The association of the IVD industry in the UK, BIVDA, is undergoing a rebrand and proactively positioning itself to reinforce the value proposition that diagnostics represent for stakeholders. A new whitepaper on the theme was one of the highlights of an upbeat 2017 annual general meeting, in which Brexit and the EU IVDR for once were not the "stars" of the show.

United Kingdom In Vitro Diagnostics

Three-Year EU MDR Transition Period? More Like 12-18 Months

So, you think you have nearly three years to comply with the EU's Medical Device Regulation and five years with the IVD Regulation. Not so. The clock has started ticking and industry has reason to be concerned.

Europe Medical Device

Global Medtech Guidance Tracker: September 2017

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-eight new guidance documents were posted to the tracker.

Regulation Singapore

Contradictory Messages Over Medtech and Brexit: MDR? No MDR?

Nearly 16 months after the Brexit vote, uncertainty persists over whether the EU's Medical Device and IVD Regulations will be adopted by the UK. Stakeholders tried to wade through the morass at two recent London meetings.

Medical Device Europe
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