UK Responsible Person and Brexit transition consulting for medical device companies

ANSWERED ON THIS PAGE:

  • What will the post-Brexit UK regulatory system look like?
  • Will UK companies need in-country representation in the EU?
  • How can medical device companies prepare for Brexit?

Brexit will significantly affect medical device companies who wish to sell across the Channel, particularly regarding in-country representation. After the UK left the EU on February 1, 2020, a transition period began. Now that this period has come to an end, medical device companies should prepare for a situation in which the UK is no longer part of the EU. It is very unlikely that ongoing negotiations will result in a situation where the UK remains part of the Union market.  With offices in the UK and the Netherlands, Emergo by UL can help you prepare for and navigate compliance requirements through Brexit.

Medical device in-country representation (UK Responsible Person) in the post-Brexit United Kingdom

The Medicines & Healthcare products Regulatory Agency (MHRA) published a revised guidance document indicating that CE marked devices will initially be recognized in the UK and emphasizing their commitment to the MDR/IVDR, irrespective of the outcome of the negotiations about the future relationship with the EU. The legislation promulgated “will mirror all key elements” in the MDR/IVDR. The guidance specifies that under the new relationship, the representative in the UK will be termed the “UK Responsible Person” (UKRP). A UKRP must be appointed from January 1, 2021, and the UKRP must register the manufacturer, any relevant importers, and the devices with the MHRA. The MHRA plans to eventually replace the CE mark with a UK Conformity Assessment (UKCA) mark; its use is currently expected to become mandatory on June 30, 2023.

Medical device authorized representation (EC Rep) in post-Brexit European Union

EU-based manufacturers distributing their devices in the remaining Member States (EU27) will require a UK Responsible Person to distribute their devices in the UK. Non-EU manufacturers using an EU27-based AR will require a UK Responsible Person to distribute their devices in the UK. Non-EU manufacturers using a UK-based authorized representative (AR) will need to appoint a new EU27-based AR (and retain their existing UK representative as the UK Responsible Person). UK-based manufacturers will become non-EU manufacturers, who will need to appoint an EU-27 based AR if they want to place devices on the Union market.

 

Looking for information about the EU MDR?

Emergo by UL provides in-country representation in the UK and EU

Emergo is uniquely positioned to help you navigate regulatory compliance through Brexit. Whether a transition period follows the UK’s withdrawal or not, you can establish representation in the UK and the EU through our offices in Sheffield, UK and The Hague, Netherlands. Here’s how we can help:

  • For UK-based companies, we can act as your EC Rep.
  • For EU-based companies, we can act as your UK Responsible Person, if needed.
  • Unique delayed-start option: secure representation in the UK or EU and activate service upon UK withdrawal according to terms of the Brexit agreement.
  • Perform a completeness review of key components of your Technical File and review your draft labeling.

Emergo is one of the largest European authorized representatives for medical device and IVD manufacturers, representing hundreds of companies worldwide. Contact us to learn more about Brexit transition and representation services.

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