Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

MHRA Grants Extra Year For CE-Marked Devices To Access UK Market

One looming cliff edge is averted, to industry’s relief

Executive Summary

The UK regulator is likely to establish mid-2024 as the new deadline for the standstill period during which CE-marked devices may access the UK market. Compulsory UKCA marking would accordingly also be delayed by a year.

You may also be interested in...



UK MHRA Gives CE-Marked Devices More Breathing Space In GB

The long-awaited extension of the UK MHRA’s standstill period for CE-marked devices circulating on the Great Britain market was announced in late April, offering new transition deadlines that go beyond the one extra year promised by the agency in fall 2022. Industry is studying the implications.

Diagnostics Industry Helps MHRA Shape IVDs Roadmap As Part Of Future UK Regulation

The MHRA will build its new UK system of medtech regulation on seven regulatory pillars, one of which is an IVD roadmap, says diagnostics industry association BIVDA. The trade body gave an update on the focus groups, UKAB numbers and timings for three awaited statutory instruments.

SME Success: How Eyenuk Traversed ’Stringent’ EU MDR For AI Eye Screening System

The new EU Medical Device Regulation sets a high bar for medtech companies. Kaushal Solanki, founder of US-based Eyenuk, tells Medtech Insight how the firm navigated the new regulation and gained two extra indication approvals for its class IIb eye screening device.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT145964

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel