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


Brexit Q&A: Where Do Notified Body, Authorized Representative Offices Need To Be?

Executive Summary

Medtech regulatory service providers cannot afford to "wait and see" on the final outcome of Brexit. Questions such as the appropriate base of operations to serve device companies looking to sell into the UK and the EU are swirling. So how should the sector be covering its back? Medtech Insight spoke to John Adcock of Advena, a consultancy that serves as an authorized representative, to find out his views.

You may also be interested in...

UK Plans To Implement Medtech Regulations, Keep Them Until At Least Summer 2019, Observers Suggest

The uncertainty over the UK position in Europe, on top of the questions surrounding many aspects of the implementation of the EU’s forthcoming medtech regulations, is making any efforts at planning difficult for many in the medtech sector. But indications are that the UK will be on board the EU medtech ship a while longer.

UK Regulator Puts Energies Into COVID-19 While Other Services May Take Longer

With finite resources, the UK’s regulatory agency responsible for health care products is rapidly addressing COVID-19 medtech issues. But shifting its focus will cause delays elsewhere.

EU Regulatory Roundup, March 2020: MDR Delay And Unprecedented COVID-19 Measures

Non-CE-marked products on the EU market, virtual notified body audits, free standards and the Commission bid to pause the MDR. March has seen unprecedented developments as COVID-19 has railroaded through the sector decimating regulatory rules and plans.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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