May 25, 2021
Several months have passed since Brexit came into force. Therefore, it may be beneficial to revisit Brexit, the U.K. Conformity Assessed (UKCA) Mark and its impact on the medical device market.
The new changes can be grouped into three main categories:
- Getting your device certified
- Packaging and labeling your device
- Registering your device with the MHRA
UL offers testing and certification services to help get your healthcare devices certified for use in the U.K.
Getting your device certified for use in the U.K.
Concerning device certification, since Jan. 1, 2021, the UKCA mark is the new product safety marking used for most goods being placed on the market in Great Britain (England, Wales and Scotland).
However, CE marking will continue to be recognized in Great Britain until June 30, 2023.
In addition, UKCA product marking route is already available for manufacturers wishing to apply the UKCA mark from Jan. 2021. The assessment is based on the U.K. Regulation MDR 2002 (as amended) which is mainly based on the European Directives for medical devices and IVDs (invitro diagnostic devices).
It should be noted that under Brexit arrangements, Northern Ireland, though part of the U.K., has special status, and different arrangements apply.
After June 30, 2023, all devices entering the British market will need to be certified through the UKCA marking process.
Impact on labels and packaging
Based on the certification approach chosen by the manufacturer, information provided on packages and labels will be impacted:
- From Jan. 1, 2021, to June 30, 2023: If manufacturers have decided to follow the CE marking process, labels with the CE mark will be accepted in Great Britain,
- From Jan. 1, 2021: If the UKCA marking path will be followed, the UKCA mark will need to be affixed as well as the name and address of the UKRP (U.K. Responsible Person). In this case, dual marking (CE and UKCA) on the labels will be accepted by the Medicines and Healthcare products Regulatory Agency (MHRA).
- From July 1, 2023: The UKCA mark will become mandatory. However, so far, the MHRA guideline suggests that dual marking (CE and UKCA) will still be accepted.
Registering your device with the MHRA
Manufacturers based outside of the U.K. and wishing to place a device on the U.K. market need to appoint a single U.K. responsible person (UKRP) who will take responsibility for the products in the U.K.
The U.K. responsible person can be an importer until its legal entity is registered in U.K.
After Jan. 1, 2021, all medical devices, including IVDs, placed on the Great Britain market need to be registered with the MHRA. A grace period will apply for registering:
- Class IIIs and Class IIb implantable, and all active implantable medical devices and IVD List A products must be registered starting May 1, 2021.
- Other Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs must be registered starting Sept. 1, 2021.
- Class I devices, custom-made devices and general IVDs (that do not currently need to be registered) must be registered starting Jan. 1, 2022.
Manufacturers of Class I devices, custom-made devices and general IVDs that, prior to Jan. 1, 2021, were required to register their devices with the MHRA, i.e., U.K.-based manufacturers or third country manufacturers with Northern Ireland-based authorized representatives, must continue to register their devices from Jan. 1, 2021, on the same basis as they do now rather than in line with the above dates.