The U.K. has published guidance on registering to sell medical devices after it completes its split from the European Union at the end of the year.
In the guidance, the Medicines and Healthcare products Regulatory Agency details who will need to register and by when. The timeline is determined by the previously disclosed grace period for registering devices.
- MHRA issued the guidance this week against a backdrop of growing acceptance that the U.K. may fail to form a trade deal despite concerns about the disruption and damage of a hard split.
The transition period that has kept the U.K. subject to EU law in recent months is set to stop at the end of the year. With three weeks to go, many details of what happens after that remain unclear due to the continuing inability of the two sides to reach agreement on some points, notably the extent to which the U.K. should be required to harmonize its standards with those of the EU.
Medical device manufacturers that move components and products across borders between the EU and U.K. will be affected by the trade deal, or lack thereof, but are still waiting for information on the situation they will face in the new year.
In the absence of answers to the big questions, MHRA has continued to share guidance on some of the details of post-Brexit life for medical device companies active in the U.K. The latest update covers how to register medical devices for use in the U.K. from Jan. 1 onward.
The guidance differentiates between England, Scotland and Wales — known collectively as Great Britain — and Northern Ireland, the fourth country in the U.K. That approach reflects an agreement intended to stop the creation of a hard border on the island of Ireland by keeping Northern Ireland subject to EU law.
Before making a medical device available for sale in Great Britain, a manufacturer must register with MHRA. Manufacturers based outside of the U.K. need to appoint a Responsible Person registered in the country. The Responsible Person will register the device with MHRA.
The situation in Northern Ireland is different, with MHRA stating companies will need to tell it before placing a device on the market "in some circumstances." Manufacturers based in Great Britain will need an Authorized Representative in the EU or Northern Ireland to access Northern Ireland.
MHRA wants manufacturers to appoint a UK Responsible Person as soon as possible after Jan. 1 but is providing a risk-based grace period for registering devices. Across the U.K., manufacturers of Class III and other higher-risk devices have until May 1 to register. MHRA is giving manufacturers of Class IIa devices and other moderate-risk products until Sept. 1.
The situation for Class I devices and general in vitro diagnostics differs between Great Britain and Northern Ireland. Manufacturers have until the start of 2022 to register the products for use in Great Britain. However, there is no grace period for the lower-risk products in Northern Ireland as existing registration requirements will continue to apply once the transition period ends.