On January 31, 2020, the United Kingdom officially left the free trade area of the European Union. Since the end of the transition period on December 31, 2020, the European rules under which products can be freely traded within the European Union no longer apply to the United Kingdom. This means that products with a European (quality) label will no longer be automatically recognized in the United Kingdom. And those in the United Kingdom will no longer be recognised in the EU until they follow the proper EU Medical Device Regulations also known as Regulation (EU) 2017/745
One of the most important European quality marks that will no longer be recognized due to the Brexit is the CE mark. As of January 1, 2022, almost all products that were previously CE marked must have a UKCA mark to be allowed on the UK market. In this blog, we explain the UKCA in detail and how to make your devices legally recognised on the UK market.
"Medical Device manufacturers selling in the UK have new responsibilities post-Brexit." Learn how you can be registered and be fully represented in the UK just in time for the UK MHRA deadline
UK Conformity Assessed (UKCA mark)
The UKCA mark is the UK equivalent of the CE mark. Most products that could previously be traded within the UK with a CE mark will need to be UKCA marked from January 1, 2022. Until then, products can be marketed with both the CE mark and the UKCA mark.
The quality requirements necessary to obtain a UKCA mark are largely the same as for the CE mark. The method of obtaining a UKCA mark is also the same. So, in practice, this means that a product that meets the requirements for CE marking can probably obtain a UKCA mark in a fairly easy way.
UK conformity assessment bodies: With the new marking, all notified bodies based in the UK ceased to be notified on 31st December 2020. As defined by the new MDR, notified bodies are located in an EU member state where there is a mutual recognition agreement between the government and the EU. Most of the Notified Bodies that were based in the UK relocated their services to different EU states and currently continue to offer their services for medical device manufacturers who are interested in entering the European market.
Currently, the UK conformity assessment bodies that are still operational are recognised as approved bodies. They approve products that are already UKCA marked and intend to sell in the UK. Medical Device manufacturers selling in the UK and EU will require to appoint both the UK approved body and an EU notified body. The Case is quite different for manufacturers who want to enter North Ireland.
Note: Since Northern Ireland remains part of the European Free Trade Area even after the Brexit, products traded in Northern Ireland do need to be CE marked again. To ensure that you can trade both in the UK and North Ireland, your product will need to be marked with both a CE & UKCA
How to Make Medical Devices legal in the UK
While the UK and the EU are no longer issuing CE marking for all Medical Devices, they have offered a grace period for when all manufacturers are required to get the appropriate marking. Until then, all products that already have a CE mark may be traded within the EU and UK. For example, machines, personal protective equipment, medical devices and toys must be CE marked. The aforementioned products should therefore meet all requirements in the area of safety, health and environment.
Note: If your product already has a CE mark, it will be recognised in the UK until 30th June 2023. On 1st July 2023, the UKCA mark will be effective on all medical devices and IVDs. However, to ensure you can legally sell your products in the UK within this period, you will need to follow more steps.
- Appoint a UK responsible person (UKRP). This agent will have different responsibilities including, reporting to MHRA about any complaints about your devices.
- Follow the deadlines. Different devices have different deadlines.
- Ensure that the products are correctly and properly labelled as per the guidelines of UKCA
"Medical Device manufacturers selling in the UK have new responsibilities post-Brexit." While the medical Devices with the CE mark will be recognised for the grace period till 2023, it is advisable companies start the process of transferring to UKCA as soon as possible. There are currently more than 100,000 medical devices on the UK market which puts pressure on the different bodies to offer proper marking to all the devices by the projected timeline. It is important for manufacturers to carry out thorough research on this subject before they enter the UK market.
How can EuroDev help?
The European Business Development Group maintains partnerships with North American companies. Through the offering of a variety of business expansion services, EuroDev has played a pivotal role in the European expansion of over 400 North American companies since 1996. For further market, information, contact us at firstname.lastname@example.org. Your partnership with EuroDev can accelerate submissions and approvals for manufacturers who want to expand into these markets.
EuroDev, established in 1996 with offices in The Netherlands and France, has a single, defined purpose to help mid-sized North American companies expand their business in Europe. We have created a proven, successful business development model and since our founding, have partnered with over 400 companies to help them define and meet their European business goals. Services provided include Sales Outsourcing, HR Outsourcing and Digital Marketing.