Manufacturer Requirements for Marketing a Medical Device
Under the UK MDR 2002 section 2, a manufacturer is defined as whether you manufacture a medical device by yourself or are outsourcing it to third parties, this would be deemed that you are the manufacturer under the regulation.
Before placing any medical device, including in vitro diagnostic medical devices (IVDs), on the Great Britain market, manufacturers need to be registered with the MHRA. If a manufacturer is not located in the UK they will need to appoint a UK Responsible Person. The UK Responsible Person will then assume certain responsibilities on behalf of the manufacturer including registering the medical device of the manufacturer with the MHRA. An importer or distributor can act as an UK Responsible Person.
Failure to register your devices will mean that you are unable to lawfully place your device on the Great Britain market.
Conformity Requirements: UKCA and CE Marks
As a general approach, prior to advertising a device to any audience it is required to be covered by an appropriate marking. The UKCA (UK Conformity Assessed) marking is a UK product marking used for certain goods, including medical devices, being placed on the Great Britain market (England, Wales and Scotland).
In obtaining the conformity for the UKCA mark, there is an option for certain devices (non-sterile and non-measuring Class I devices and general IVDs), to self-certify the UKCA marking. However, for the medical devices under Parts II, III, and IV of the UK MDR 2002, UK Approved Bodies would conduct conformity assessments in relation to the UKCA marking.
Until 30 June 2023, the CE or the UKCA markings can be used on the medical devices’ packaging. From 1 July 2023, a UKCA marking will be required in order to place a device on the Great Britain market.
Therefore, a medical device can have both the CE and UKCA markings present on the labelling prior to 1 July 2023, and dual marking will continue to be accepted on the Great Britain market after 1 July 2023.