How has Brexit Impacted manufacturers of medical devices?

FAQ - Frequently Asked Questions

How has Brexit changed how I import my Medical Devices to the UK?

Now that the UK has left the EU and it's single market Importers now have to comply with the new UK regulations:

• You will need a UK responsible person
• Your products will need a UKCA mark when the grace period ends
• All products will need to be registered with MHRA
• On all your products labels you will need have the name of your UK responsible person (UKCA will be required after the grace period)

What is UKCA?

The UKCA (UK Conformity Assessed) mark is the the UK's product marking used for Medical devices, and other certain goods, that are placed on the UK market.

Manufacturers can use the UKCA on a voluntary basis until 30th June 2023. From 30th June 2023, the UKCA mark will be compulsory to place a device on the the UK market

Do you require UK RepMed Limited's Services?

If you want to import your medical devices to the UK and you do not have a UK responsible person and need your devices registered with MHRA then YES you do require our services.