The UK medical devices market has had to adapt to Brexit and the UK’s changing business relationship with other countries. One of the biggest question marks facing the medical community is the necessity of CE marks and/or UKCA marks. These marks, and others like them, are used to ensure that all products are certified, conform to regulations, and are registered with the relevant body such as the MHRA. We’re going to look at the regulations and find out when and why CE marking for medical devices is required.
As a trusted medical device manufacturer, we have decades of experience in this area and offer regulatory services such as CE marking for medical devices as part of our contract manufacturing service. In this capacity, we have seen all the changes made to regulations over the years and are perfectly placed to provide you with the support you need to develop, manufacture and roll out your medical device.
As part of the medical device regulations in the UK, we’re going to look at why marks, such as CE marks, are still needed.
What is CE marking for medical devices and when is it required?
CE marking is an indicator that a medical device complies with EU legislation. This well-known mark will continue to be recognised in Great Britain until the 30th of June 2023.
With the advent of Brexit, the rules have changed and the UKCA mark has been introduced. This mark is controlled by the MHRA and regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) which covers:
- Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
- Directive 93/42/EEC on medical devices (EU MDD)
- Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)
Do I need a UKCA mark to replace a CE mark?
In short, yes. You will need to update to the UKCA mark by the 30th of June 2023. From 1 July 2023, a UKCA marking will be required in order to place a device on the Great Britain market. UKCA stands for ‘UK Conformity Assessed’ and is a mandatory requirement on a product to indicate it confirms to British legislation.
The legislation itself is only a slight change from the existing CE mark requirements in the UK. The British Standards Institute (BSI) has indicated as much and maintains its commitment to international standards systems to ensure ‘harmonised standards’. You can also place several marks on your packaging to ensure you cover as many bases as possible as long as you have the certifications.
It’s also worth keeping up to date with the latest changes as and when they happen as the MHRA and other bodies make adjustments.
What are the limits of the UKCA mark?
The UKCA mark is limited in scope and is only valid in Great Britain. This includes England, Scotland, and Wales. CE marks will continue to be used for trade in Northern Ireland as well as the Republic of Ireland as they remain closely aligned with the EU single market.
Europlaz – Over 50 Years of Experience in Medical Device Contract Manufacturing
With all of our experience, we have the knowledge, skills, and systems to help you navigate the medical device manufacturing process and ensure your product is eligible for whatever market you want to reach. We hope this blog has helped you understand what and why CE marking is required for medical devices even after the introduction of the UKCA mark.
If you need any support, we have the team to take your medical device from design and prototyping to manufacturing and ensure a high-quality product. We can also support this process with transparent Quality Assurance as well as CE Marking.
If you’re interested in finding out more or would like to set up a product discovery meeting to discuss your ambitions, please contact us today. Our team is on hand to assist you every step of the way and ensure patients benefit from a product or device that they can trust.
