Now that Brexit took place on 31 December 2020, a new British system is in effect e.g. for product certification, conformity marking and for the registration of devices with the Medicines and Healthcare products Regulatory Agency (MHRA), the agency responsible for regulating the British medical device market. The rules in effect for Great Britain, which consists of England, Wales and Scotland, differ from those in effect for Northern Ireland.
Regulations in Great Britain
For medical device manufacturers, e.g. the following rules apply with respect to the placement of their devices on the market:
- CE markings will continue to be recognized in Great Britain through 30 June 2023.
- Certificates issued by EU-recognized Notified Bodies will be valid in the Great Britain market through 30 June 2023.
- The EU no longer recognizes UK Notified Bodies.
- UK Notified Bodies may not issue CE certificates (other than for purposes of “CE UKNI” marking, which is valid in Northern Ireland) and have become “UK Approved Bodies.”
- New rules apply for market and product marking.
As of 1 January 2021, all medical devices which are placed on the market in Great Britain, including in-vitro diagnostics (IVDs), must be registered with the MHRA. The following periods apply for registration:
- Class III and Class IIb implantable products and all active implantable medical devices and IVD List A products must be registered as of 1 May 2021.
- Other Class IIb devices and all Class IIa devices, as well as IVD List B products and Self-Test IVDs, must be registered as of 1 September 2021.
- Class I devices, custom-made devices and general IVDs (which currently do not have to be registered) must be registered as of 1 January 2022.
Manufacturers which are not based in the United Kingdom must appoint a responsible person for Great Britain which will take responsibility for the product in Great Britain (UK Responsible Person).
If the importer is not the UK Responsible Person, the importer must notify the UK Responsible Person of its intention to import a device into Great Britain. In such cases, the UK Responsible Person is required to provide the MHRA with a list of device importers. The previous obligations regarding storage, transportation and checking device labels for the CE marking or UKCA marking will continue to apply for importers and distributors. The importer’s name and address does not need to be present on the label unless the importer or distributor is acting as the UK Responsible Person for the purposes of the UKCA mark.
UKCA mark and CE mark
The UKCA (UK Conformity Assessed) mark is a UK product marking used for certain goods, including medical devices, being placed on the market in Great Britain. The UKCA mark is not recognized in the EU, EEA or Northern Ireland markets, so relevant products require a CE mark for sale in these markets.
Manufacturers can use the UKCA mark on a voluntary basis until 30 June 2023. From 1 July 2023, a UKCA mark will be required in order to place a device on the Great Britain market.
CE-marked devices will continue to be accepted on the British market through 30 June 2023 provided they conform to the EU Directives still in effect, or the Regulations which will take effect in the future, the MDR or the IVDR. CE certificates which conform to these rules will continue to be recognized through 30 June 2023.
In other words, devices which already have a valid CE marking do not have to be re-labelled with a UKCA mark in order to be placed on the British market through 1 July 2023. Devices can have both marks present on the labelling prior to 1 July 2023, and dual marking will continue to be accepted on the British market after 1 July 2023. However, the name and address of the UK Responsible Person, where applicable, needs to be included on product labelling where the UKCA mark has been affixed (including when devices have been dual marked).
Where third-party conformity assessment is required, a UK Approved Body is needed. However, Class I device and general IVD manufacturers can self-certify with the UKCA mark.
The MHRA can designate UK Approved Bodies. Existing UK Notified Bodies with designations under the EU MDD, EU IVDD or EU AIMDD have had their designations rolled over automatically without having to undergo a new designation process.
For the purposes of the Great Britain market, UK Approved Bodies can conduct conformity assessments in relation to the UKCA mark for medical devices, active implantable medical devices and in vitro diagnostic medical devices under Parts II, III, and IV of the UK MDR 2002 (as amended). But UK Approved Bodies are not able to conduct conformity assessments in relation to the CE marking other than for the purposes of the “CE UKNI” marking, which is valid in Northern Ireland.
Regulations for Northern Ireland
The following rules apply for medical device manufacturers seeking to place their devices on the market in Northern Ireland:
- Devices must conform to the requirements of the MDR and IVDR as of 26 May 2021 and 26 May 2022 respectively.
- CE marking is required.
- UKNI marking is also required if a UK Notified Body is involved in the conformity assessment process.
Manufacturers are required to affix UKNI marking to their devices in addition to CE marking if they decide to use a UK Notified Body for the prescribed conformity assessment procedure. Device manufacturers must never apply the UKNI marking on their own – it must always accompany a CE marking. However, goods bearing the “CE & UKNI” marking will not be accepted on the EU market.
The above aspects are only the most important of the new regulations which will apply for the placement of medical devices on the market in Great Britain and Northern Ireland. The aforementioned rules are supplemented by a wide range of individual and detailed rules for many different product classes, the description of which would exceed the bounds of a newsletter article. Before placing devices on the market, manufacturers should examine the rules which apply to them and to their specific device in order to ensure that their devices meet the requirements for substantive conformity as well as the specific labeling and product registration requirements in Great Britain and Northern Ireland.back