UKCA FOR MEDICAL DEVICES

UKCA marking (UK Conformity Assessed marking) is the proposed UK product marking requirement that will be needed for products being placed on the UK market, substituting the EU requirements for CE Marking.

UKCA can be used to replace the CE Marking requirements at the end of the European Union exit transition period. This is referred to officially as the implementation period completion day (“IP Completion day”) which is scheduled to occur at 23:00 on 31st December 2020.

On 1 September 2020, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released guidance on how medical devices will be regulated in the UK after this transition period

Government guidance

GOVERNMENT GUIDANCE MAIN POINTS

The following timeline provides information on the key dates, including the requirements for registering products with the MHRA (please note that this is the current guidance, which may change as the political and trade negotiations continue):

Other points to note:

• UKCA mark will not be recognised in EU, EEA or Northern Ireland
• For Northern Ireland, either the CE mark or dual UK(NI) CE mark will be required
• UK Responsible Person will be required if the manufacturer is located outside the UK
• UK Approved Bodies will be designated from 1 January 2021
• Following approval from a UK Approved Body, a manufacturer will be able to affix the UKCA mark (in Great Britain), or UK(NI) mark (in Northern Ireland)

HOW DOES THIS NEW UKCA PROCESS AFFECT YOU?

The two key immediate points of impact for you as a manufacturer are:

1. Product registration: the immediate impact to you is to ensure you register your products with the MHRA as soon as possible from 1 January 2021. As noted above, all devices to be placed on the market in the UK must be registered with the MHRA within the specified grace period (depending on the classification of your product). In order to register with the MHRA you must show evidence of having undergone conformity assessment by a UK Approved Body, or an EU Notified Body (in which case you should have CE certification). The CE mark will continue to be recognised; therefore, you can continue to place your products on the market in the UK until 30 June 2023.
   
   For further information on how to register your device with MHRA, please follow the links below:
   
   MHRA | Register as a manufacturer to sell medical devices
   
   MHRA | Device Online Registration System, DORS
2. UK Responsible Person: If you are located outside of the UK, you will be required to appoint a UK Responsible Person (UKRP), located in the UK. The UKRP responsibilities will include registering your devices with the MHRA. UKRP should be appointed in line with the grace periods defined for device registrations.

WILL YOU NEED TO RE-LABEL ALL YOUR PRODUCTS WITH THE UKCA MARK?

If your device is CE certified, you can continue place your product in the market in the UK until 30 June 2023, there will not be the need to re-label.

Please note that the requirements in Great Britain (England, Wales, Scotland) and Northern Ireland differ:

• In GB – CE marked devices can be placed on the market until 30 June 2023. After this date UKCA requirements will be mandatory, and the UKCA-mark will be required
• In NI – CE marked devices can be placed on the market, even after 30 June 2023

WHY CHOOSE TÜV SÜD FOR UKCA MARKING

For over 30 years, TÜV SÜD has provided market access solutions and regulatory expertise for manufacturers and suppliers of medical devices and in vitro diagnostics. Our services put your product through its paces and ensure medical device market approval and acceptance.

With our TÜV SÜD Product Service GmbH Notified Body and TÜV SÜD Limited (UK) applying to become a UKCA Approved Body, our dedicated team of experts will be able to offer both CE marking and UKCA marking services following the transition.

The UK Approved Body designation process will open from 1 January 2021 under the UK Legislation MDR 2002, SI #618) and TÜV SÜD has already engaged in the process with the MHRA.

Please note, this information is based on current guidance. As the political and trade negotiations continue between the UK Government and the EU, there may be further changes to our current understanding. TÜV SÜD will continue to keep you informed on any changes and how it may affect you.