OVERVIEW
From 1 January 2021, the roles and responsibilities of those manufacturing and supplying medical devices and IVDs will change.
Manufacturers wishing to place a device on the UK market will first need to register with the MHRA.
Where a manufacturer is not established in the UK, in most cases it will need to designate a UK Responsible Person to register and act on its behalf.
Manufacturers will need to comply with relevant product marking and conformity assessment requirements for medical devices, including IVDs.
DEVICE REGISTRATION REQUIREMENTS IN GREAT BRITAIN
From 1 January 2021, any medical device, IVD or custom-made device will need to be registered with the MHRA before being placed on the Great Britain market.
The MHRA will only register devices where the manufacturer has a registered place of business in the UK. If the manufacturer is based outside the UK, they will need to designate a UK Responsible Person that has a registered place of business in the UK. This UK Responsible Person will then assume the responsibilities of the manufacturer in terms of registering the device with the MHRA.
These new registration requirements will not apply until 1 January 2021 and that there will be a grace period for registrations, as set out below.
The requirement for a manufacturer to have in place a UK Responsible Person is in line with the grace period for registering devices with the MHRA.
If you are a Northern Ireland-based manufacturer and have registered your device with the MHRA for the purposes of Northern Ireland, it can then freely flow between Northern Ireland and Great Britain and will not need to undergo any further registration in Great Britain.
UK RESPONSIBLE PERSON
As noted above, to place a device on the Great Britain market, non UK manufacturers will need to appoint a UK Responsible Person that is established in the UK.
Requirements for appointing a UK Responsible Person to place devices on the Northern Ireland market are covered separately below.
The UK Responsible Person will act on behalf of the outside-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. This includes registering with the MHRA before the manufacturer’s devices can be placed on the UK market.
The responsibilities of the UK Responsible Person will be set out in the UK MDR 2002 (in the form in which they exist on 1 January 2021). In summary, the UK Responsible Person must:
- Ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
- Keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA.
- In response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device.
- Forward to the manufacturer any request by the MHRA for samples, or access to a device, and ensure that the MHRA receives the samples or has been given access to the device.
- Cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
- Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
- Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the MHRA and, if applicable, the relevant notified body of that termination.
UKCA MARK AND CONFORMITY ASSESSMENT BODIES
UKCA mark
The UKCA (UK Conformity Assessed) mark is a new UK product marking that will be used for certain goods, including medical devices, being placed on the Great Britain market after the transition period. The UKCA mark will not be recognized in the EU, EEA or Northern Ireland markets, and products currently requiring a CE marking will still need a CE mark for sale in these markets. Manufacturers will be able to use the UKCA mark from 1 January 2021.
From 1 July 2023, to place a device on the Great Britain market, you will need to meet the requirements for placing a UKCA mark on your device. This requirement will not apply to Northern Ireland traders.
UK Conformity Assessment Bodies
From 1 January 2021, the MHRA will be able to designate UK Conformity Assessment Bodies to conduct assessments against the relevant requirements for the purpose of the UKCA mark.
Existing UK Notified Bodies with designations under the MDD, IVDD or AIMDD will have their designations rolled over automatically, without having to undergo a new designation process.
UK Conformity Assessment Bodies will only be able to 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 (in the form in which they exist on 1 January 2021).
RECOGNITION OF CE MARKED MEDICAL DEVICES IN GREAT BRITAIN
The MHRA will continue to recognize the CE mark for devices until 30 June 2023. This will apply to devices placed on the Great Britain market that have been CE marked under and fully conform with the following applicable EU legislation:
- Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
- Directive 93/42/EEC on medical devices (EU MDD)
- Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)
- Regulation 2017/745 on medical devices (EU MDR)
- Regulation 2017/746 on in vitro diagnostic medical devices (EU IVDR)
From 1 July 2023, new devices placed on the Great Britain market will need to conform with UKCA marking requirements.
If you currently CE mark your medical device on the basis of self-certification, you will be able to continue to do so after 1 January 2021 and place your device on the Great Britain market until 30 June 2023.
Source:
Guidance: Regulating medical devices in the UK https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk