How Will British Device Registration Work After Brexit?
September 9, 2020
The United Kingdom (UK) has issued guidance for medical device registration in the period following the UK’s withdrawal from the European Union. The guidance establishes separate systems between Northern Ireland and the rest of the United Kingdom.
From Jan. 1, 2021, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will handle medical device registration for products to be sold within the UK, to include England, Wales and Scotland.
The new registration procedures will not apply to Northern Ireland, however. Instead, for EU registration and a CE mark, Northern Ireland will conform with the Republic of Ireland, which remains in the EU, and with whom Northern Ireland shares a land border.
Changes to medical device registration and marketing under the UK’s MHRA will include:
- EU CE marking will be valid until June 30, 2023. After that date, products marketed in the UK will need a UK Conformity Assessment mark (UKCA) conferred by UK Conformity Assessment Bodies.
- Grace periods for UK registration will apply: four months for Class lll and Class llb implantable devices and all active implantable medical devices; eight months for other Class llb and all Class lla devices; 12 months for Class l devices. The 12-month grace period will not apply to Class l devices and general in-vitro diagnostics currently required to register with MHRA.
- To place a device on the UK market, companies outside the UK will need to establish a UK “Responsible Person” to register the product.