UKCA marking for medical devices.

The UK medical devices, are regulated by the Medicine and Healthcare product Regulatory Agency (MHRA). If a medical device manufacturer wants to place their product in Great Britain then they need to have UKCA marking meaning UK product marking. UKCA stands for UK Conformity Assessed, UKCA marking is a substitute for the EU requirement of CE marking.  As CE mark medical device consultant we create technical file and provide guidance for UKCA marking also. The guidance provides information that includes; getting device-certified, conformity marking, and registering the device with MHRA. One thing to note here is that as per the Northern Ireland protocol, rules to place a device in Northern Ireland market differ from Great Britain. UKCA is product marking needed for the placement of medical devices in the UK market. The term medical device here also includes in vitro diagnostic medical devices and active implantable medical devices. For the Northern Ireland market CE mark or UKNI mark is required for the placement of medical devices in the Northern Ireland market.

As per the data of the UK government, UKCA mark requirements for medical devices are based on the 3 main types of medical devices and their associated Parts in the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002):

• General medical devices: Part II of the UK MDR 2002
• Active implantable medical devices: Part III of the UK MDR 2002
• In vitro diagnostic medical devices (IVDs): Part IV of the UK MDR 2002

You need to demonstrate that your medical device meets the requirements in the UK MDR 2002 by carrying out a conformity assessment. The assessment route depends on the classification of the device. You can place a UKCA mark on your product to show that the medical device has met the requirements when you have passed the conformity assessment. A UKCA mark is a logo that is placed on medical devices to show they conform to the requirements in the UK MDR 2002. To be placed in the Northern Ireland market the medical device should bear the UKCA mark accompanied by the CE mark.

Exemptions: One should not put a UKCA mark on the product if,

• The product is exclusively for clinical investigation and meets the requirement as far as possible.
• an in vitro diagnostic medical device (IVD) for performance evaluation
• a non-compliant device used in exceptional circumstances (humanitarian grounds)
• Custom made device that meets the requirement in UKMDR 2002

Few key requirements: 

For UK medical device to be placed in GB market. From January 1, 2021, many changes were introduced, to how medical devices are placed in GB (England, Scotland, Wales) market:

• Medical devices including IVD’s and custom-made devices, should register first with MHRA.
• A new product marking i.e UKCA is available for the product to be placed in Great Britain
• If a manufacturer is outside the UK, he needs to appoint a single UK responsible person who can carry out a task such as registration on behalf of the manufacturer.
• Till June30, 2023 CE marking will continue to be recognized in Great Britain.
• Till June 30,2023 certificates issued by EU-recognized Notified Bodies will continue to be valid for the Great Britain market.
• UK notified bodies will not able to issue CE certificates.

The UKCA marking requirement is based on EU legislation such as for active implantable devices EUAIMDD, for medical devices (EUMDD) In vitro diagnostic medical devices (EUIVDD)

MHRA medical device regulation:

The Medical and Healthcare Regulatory agency is responsible for the designation and monitoring of   UK conformity assessment bodies. If a manufacturer is based in the UK and has the intention of supplying products in the GB market, they should be aware of the medical device regulation 2002 and general product safety regulation 2005.MHRA does not give any certificate, accreditation or approval for the device. As per the requirement of UKMDR 2002 manufacturer needs to inform MHRA before placing the device in the UK market.

Who can register with MHRA?

The manufacturer of Class I, ClassIIa, class IIb, class III devices, custom made devices, Manufacturer of IVDs, IVDs undergoing performance evaluation, If the manufacturer is not from UK, then he needs to appoint a single responsible person from the UK who can perform the task or complete the required things on the manufacturer\’s behalf. Distributors and suppliers are not required to register with the MHRA. To register with MHRA, MHRA may ask you to provide the following details:

• Legal entity name and address
• Company type
• Administrative contact
• Class of the device
• UDI-DI if applicable
• Medical device name

They may request further technical documentation as part of the scrutiny and data validation process. You can also refer UK government website for more info.

UKCA medical device regulations and rules:

Medical device manufacturers need to use UKCA marking before January1, 2023 if . The product is for Great Britain (England, Scotland, Wales) market. The Product requires a third-party conformity assessment. The Product is covered by legislation that requires the UKCA marking. UKCAs technical requirements, conformity assessment process and standards to demonstrate conformity are largely the same as CE marking. The placing of UKCA mark ids depends upon the product, UKCA marking can be applied on the product itself or packaging, in some cases, it may be placed in manuals it will vary as per the product. UKCA marking must be clear and visible, UKCA marking must only be placed on the product by a manufacturer. By affixing UKCA marking you take full responsibility for the conformity of the product with the required legislation. There should not be any sign or marking which may misconstrue the meaning of UKCA marking.

Few important points to remember:

Product registration with MHRA is a must, the medical devices to be placed in the UK market need to get registered with MHRA within the grace period. CE mark will be recognized till June 30,2023. If you are outside UK, the manufacturer needs to appoint UK responsible person (UKRP)

If the device is CE certified the product /device can be placed in the UK market until June30,2023. There will be no need for rebelling After June 30,2023 It will be mandatory for the manufacturer to have a UKCA mark on their medical device product to be placed in the UK market, whereas for NI (Northern Ireland) CE marked devices can be placed even after June 30, 2023.

Operon strategist is medical devices consulting has a good experience in consultation and regulatory expertise for manufacturers and suppliers of medical devices. for any medical device registration process, CE marking and licensing you can connect with us.