We need to talk about Brexit and medical devices

Feb 18, 2020 | Quality + Regulatory

On 31 January 2020, the UK left the European Union.
For the rest of the year at least, there’s a transition period during which existing arrangements apply.
You may well be wondering what this all means for you, now and afterwards.

Here’s the situation in a nutshell:

(caveat: this may change as negotiations between the UK Government and EU progress)

You are based in the UK and want to (continue) to sell your medical devices in the 27 EU countries

  • You will likely need to appoint/set up an Authorised Representative based in an EU member state
  • Your Authorised Representative will be responsible and liable for the product placed on the market – i.e. the buck stops with them for questions from regulatory authorities and notified bodies.  They will probably want to have access to the Technical File for your product(s), so they are able to respond to questions in a timely manner
  • Whoever you appoint should have access to the technical capability to support you
  • Your Authorised Representative will need to have adequate liability insurances in place
  • Consider putting a mutual confidentiality agreement in place, to protect both organisations
  • Think about how you’ll routinely share documentation and updates, whilst protecting data confidentiality and security

You’re based outside the UK and want to (continue) to sell your medical devices in the UK

  • You will likely need to appoint/set up an Authorised Representative based in the UK
  • Your Authorised Representative will be responsible and liable for the product placed on the market – i.e. the buck stops with them for questions from regulatory authorities and notified bodies.  They will probably want to have access to the Technical File for your product(s), so they are able to respond to questions in a timely manner
  • There may be a period of time during which devices approved for sale in the EU are accepted into the UK without additional certification requirements
  • Whoever you appoint should have access to the technical capability to support you
  • Your Authorised Representative will need to have adequate liability insurances in place.
  • Consider putting a mutual confidentiality agreement in place, to protect both organisations
  • Think about how you’ll routinely share documentation and updates, whilst protecting data confidentiality and security

You’re based in the UK and want to (continue) to sell your medical devices just in the UK

  • On the assumption that there is very close alignment between any UK legislation and the MDR/IVDR, you will probably be able to carry on as normal. Given the workload currently faced by Notified Bodies and MHRA, you may experience delays compared to the timescales you have been used to for device certifications, approvals and responses to questions.
  • There is no need to appoint an Authorised Representative in the UK, as you already have a presence in the country.

What’s Next?

Given the fluid nature of the regulatory landscape, you may find it useful to keep up to date with the latest developments.  Perhaps you’re concerned about the technical support available to you or your Authorised Representative.  Other organisations felt the same worries, they found relief in having expert support to lean upon.
Our clients rest easy, knowing that they have full access to our expert technical support, helping them:
  • Evaluate potential Authorised Representatives
  • Provide their chosen Authorised Representative with the technical back up they need
  • Check the health of product Technical Files- ensuring they stand up to scrutiny
  • Keep an ear to the ground for the latest regulatory and Notified Body intelligence

It’s probably no surprise people lean on us, as we’ve more than 25 years experience they can draw upon so make their lives easier.

Maybe this is something you’d find useful?  Take the first step, get in touch today.