Once the transition period ended on 31 December 2020, EU trade mark registrations ceased to have registered effect in the UK. To remedy this, the UK Intellectual Property Office automatically 'cloned' all EU registrations to create comparable UK national records.
The new UK rights were allocated a UK registration number, but otherwise the details of the 'new' UK registrations stayed the same as in the corresponding EU registrations. The UK rights have the same legal status as if it had been applied for and registered as a UK registration from the original EU filing date.
If an application in the EU remained pending and was not yet protected at 31 December 2020, it will not have been cloned onto the UK register, as this only occurred for registrations. However, owners of such pending EU applications have until 30 September 2021 to apply for an equivalent UK trade mark application. This UK 'conversion' option would offer the advantage of preserving the EU record's original filing date. National UK filing fees are payable, and the converted UK application would be subject to the UK examination process.
Brexit is having a significant impact on the medtech sector. Manufacturers of medical devices (including software and in vitro diagnostic (IVD) devices) who sell – or are planning to sell – their products in Great Britain (England, Scotland and Wales) are now faced with meeting a new set of regulatory requirements. (Under the Northern Ireland Protocol, a sort of hybrid regulatory framework, sharing elements of both EU and UK requirements, will apply in Northern Ireland, however this isn’t covered in detail here.) Brexit’s effects will be felt in such areas as the regulatory conformance assessment process, product labelling and – for manufacturers based outside of the UK – product registration.
CE marking will continue to be recognised in Great Britain until 30th June 2023 (and beyond this date in Northern Ireland), with no changes required apart from registration with the UK Medicines and Healthcare Regulatory Agency (MHRA). As of 2021, all products sold in the UK must be registered, and manufacturers based outside of the UK must appoint a UK Responsible person (UKRP) who will register the products and will serve as the manufacturer’s UK point of contact for the MHRA.
From 1 July 2023, all medical devices and IVDs sold in Great Britain must meet the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (‘UK MDR 2002’), which is based on the well-known EU Medical Devices Directive 93/42/EEC. (The incoming EU Medical Devices Regulation (EU MDR) will not apply to Great Britain). Once the product meets all relevant performance and safety requirements as set out UK MDR 2002 (for higher risk devices, this must be confirmed by a UK conformity assessment body, such as BSI), has been registered and displays the new ‘UKCA’ (conformity assessment) on its labelling, the manufacturer will be able to market the product in Great Britain.