Until January 2021, medical devices in the UK were regulated under the European regulatory framework. After Brexit and the withdrawal of the UK from the EU, the UK government has had to put a full stop on the implementation of the European Medical Devices Regulation (MDR, 2017/745).
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has reintroduced their own UK MDR from 2002 combined with modifications of the previous European Medical Devices Directives Directive 90/385/EEC on active implantable medical devices (EU AIMDD), Directive 93/42/EEC on medical devices (EU MDD), and Directive 98/79/EC on in vitro diagnostic medical devices (IVDs; EU IVDD).
Today we are taking a look at marketing medical devices in the UK market and in the EU and will guide you through which conformity assessment procedure, notified body, and mark you will use to market your medical device in each region.
CE Marking for medical devices
What is CE marking?
CE is an abbreviation for the French term conformité européenne which means European conformity. When the CE mark is placed on a medical device, it indicates that the device is manufactured in conformity with the EU Medical Devices Regulation and can be freely marketed and sold within the European Economic Area (EEA).
How do you obtain CE marking for your medical device?
In order to add the CE marking to your medical device, you must demonstrate compliance to all applicable EU regulations through the proper conformity assessment procedures.
The steps needed to affix the CE marking to your product, as defined by the European Commission, are:
- Identify the applicable directive(s) and harmonized standards
- Verify product-specific requirements
- Identify whether an independent conformity assessment (by a notified body) is necessary
- Test the product and check its conformity
- Draw up and keep available the required technical documentation
- Affix the CE marking and draw up the EU Declaration of Conformity
For some lower class devices, CE marking can be obtained through self-certification. For higher-risk devices, i.e. Class IIa, Class IIb, and Class III, the conformity assessment must be handled by a notified body.
What is UKCA marking?
Since the withdrawal of the UK from the European Union in January 2020 and the implementation of a UK medical device regulation in January 2021, the UK MHRA has been in charge of regulating the UK medical device market.
How do you obtain UKCA marking?
The UKCA marking (UK Conformity Assessed) is the UK equivalent of the CE marking scheme, and even though the name is different, the larger regulatory scheme is based on the European regulatory model:
- As a medical device manufacturer, you must appoint a UK responsible person if you are based outside of the UK
- All medical devices and IVDs must be registered with the MHRA before being placed on the UK Market
- All medical devices must undergo conformity assessment by a UK approved body before being put on the market
Is CE marking valid in the UK?
CE marking will be recognized in Great Britain until the 30th of June 2023. After this, all medical devices must carry the UKCA mark.
UK notified bodies are not recognized by the EU and cannot issue CE certificates – they have now become UK Approved Bodies.
UKCA marking is not recognized as sufficient for market approval in the EU; CE marking is still required for any medical device to be put on the European market.
The UK rules only apply to Great Britain (England, Scotland, and Wales) – aside from a few exceptions, Northern Ireland is still ruled by European regulations and the CE marking scheme, as well as the UKNI mark.
The UKNI mark is a conformity marking similar to the CE marking and UKCA marking that applies to all UK products that have undergone conformity assessment and are to be placed on the market in Northern Ireland. The conformity assessment must have been performed by a UK approved body.
EU products will continue to use the CE marking which is also recognized in Northern Ireland. The UKNI mark is not recognized in the EU market.
I’m confused – where do I use what mark?
In order to understand which mark you should be using, you need to consider which market your medical device will be marketed in.
If your medical device is manufactured in the European Union and will be placed on the EU market, you have to use CE marking.
If it is manufactured in Great Britain and will be placed on the Great Britain market, you have to use the UKCA mark.
If your device is manufactured in Northern Ireland and will be placed on the Great Britain market, you have to use both the CE and UKNI mark.
Here’s an easy overview:
- Medical devices placed on the Northern Ireland markets using an EU notified body = CE
- Medical devices placed on the Northern Ireland markets using a UK approved body = CE and UKNI
- Medical devices placed on the Great Britain market under the unfettered access* agreement = CE, or CE and UKNI
- Medical devices placed on the Great Britain market until 30th of June 2023 = UKCA or CE
- Medical devices placed on the Great Britain market after june 30th 2023 = UKCA
- Medical devices placed on the European market using EU based notified bodies = CE
- The unfettered access agreement ensures full access without addition approvals to the Great Britain market for any medical device manufactured in Northern Ireland
Even though there are different processes for the different marking schemes now used in the EU and UK, they are all derived from the same medical devices regulation and as such, they are similar in nature.
Medical device manufacturers must still undergo conformity assessment, in most risk classes validated by a third-party (notified body or UK approved body), in order to market their product. Self-certification is one option in both regulatory frameworks.
A technical file must still be prepared and maintained throughout the lifecycle of the medical device, and post-market surveillance and vigilance activities remain an important part of the responsibilities of the manufacturer.
The differences between the regulations lie in the smaller details and the administrative logistics surrounding conformity assessment and the application of the CE or UKCA mark.