Register for our free email digests:
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
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.
Latest From Europe, Policy & Regulation
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?
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.
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.
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.
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.
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.
You must sign in to use this functionality
All set! This article has been sent to email@example.com.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.