The UK medical device regulatory system is independent of the European Economic Area (EEA). All medical device manufacturers will need to follow UK laws for (in vitro) medical devices, based on the EU regulations EU-MDR 2017/745 and EU-IVDR 2017/746. All non-UK manufacturers must have a UK-based UK Responsible Person (UKRP) designated and registered at the MHRA, and take the responsibility for the product in the UK.

The UKRP is the equivalent of an EU Authorised Representative.

UK-based manufacturers need to appoint an EU Authorized Representative. UK comprises England, Scotland, and Wales. Northern Ireland is part of the UK, but will essentially remain within the EU Customs Union, so manufacturers will still comply with European rules and affix the CE mark.

Registration MHRA

All medical devices (including in-vitro diagnostic medical devices) placed on the UK market will need to be registered with the MHRA (UK). 

The registration deadlines are as follows:  

• Class III, Class IIB implantables, all active implantable medical devices, and IVD List A products must be registered before May 1, 2021.
• Other Class IIB, all Class IIA devices, IVD List B products, and Self-Test IVDs must be registered before September 1, 2021.
• Class I devices, custom-made medical devices (CMMD), and general IVDs (that do not currently need to be registered) must be registered before January 1, 2022.

UKCA mark

CE marked medical devices will continue to be recognized in the UK until June 30, 2023. After that date only the new UKCA symbol will apply. CE-certificates issued by EU designated Notified Bodies will continue to be valid for the UK market until June 30, 2023, unless the certificate expires before this date. The UKCA mark will not be recognized in the EU, EEA, or Northern Ireland markets, and products currently requiring a CE mark will continue to have a CE mark for these three markets. Manufacturers will be able to use the UKCA mark voluntarily in the period until June 30, 2023.

UKRP responsibilities

The UKRP will act on behalf of the manufacturer to carry out specified tasks in relation to the manufacturer’s legal obligations. This includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the UK market.

A UKRP is responsible for:

• ensuring that the manufacturer
  • the device declaration of conformity (DoC) complies with the requirements;
  • the technical documentation complies with the requirements;
  • has an appropriate conformity assessment procedure.
• keeping available for the MHRA
  • a copy of the technical documentation,
  • a copy of the declaration of conformity, and
  • a copy of the relevant certificate(s), including any amendments and supplements.
• responding to a request from the MHRA.
• providing the MHRA with all the information and documentation necessary to demonstrate a device's conformity.
• that the manufacturer providing samples or allow access to the device to the MHRA when requested.
• cooperating 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 informing 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.
• terminating the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under the applicable Regulations and informing the MHRA and, if applicable, the relevant ‘UK-Approved Body’ that termination.

If the manufacturer uses a UK importer that is not the UK Responsible Person, the importer will be required to inform the relevant UKRP of their intention to import a device.  In this case, the UKRP will be required to provide the MHRA with a list of device importers.  Existing obligations around storage, transportation, and checking device labels for the CE marking or UKCA marking will continue to apply.  The importer’s name and address will not need to be present on the label unless the importer or distributor is acting as the UKRP.

The period between January 1, 2021, until June 30, 2023:

• CE-certificates issued by EU-recognised Notified Bodies will continue to be valid for the UK market. After June 30, 2023, the EU will no longer recognize UK Notified Bodies.
• UK Notified Bodies will not be able to issue CE certificates (other than for the “CE UKNI” marking, which will be valid in Northern Ireland) and become ‘UK Approved Bodies’.
• A new route to market and product marking is available for manufacturers wishing to place a medical device on the UK market.
• All medical devices, including in vitro diagnostic medical devices (IVDs), placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering.
• CE mark with a UK Conformity Assessment (UKCA-mark) is voluntary, and when the UKCA mark is in use, the labeling also needs to comply.
• The name and address of the UK Responsible Person will need to be included on product labeling where the UKCA mark has been affixed.  

Note. UK Responsible Person details will not need to be included on labeling for CE marked devices.

After June 30, 2023

• All product labeling needs to comply with the UK medical device regulations, including UKCA logo.
• The UK will allow self-certification for medical devices that are Class I self-certified or general IVDs (companies can attach the UKCA mark once compliant with the UK legislation).  Higher-risk medical devices and IVDs will require approval from a UK Approved Body, who will issue a UKCA certificate. The UKCA mark can then be added to the labeling.  
• Existing UK Notified Bodies with designations under the MDD, IVDD, or AIMDD will automatically become UK Approved Bodies.  However, EU-based Notified Bodies will not be able to issue UKCA certificates.
• The UKCA mark will become mandatory for devices intended for the market in the UK. 

Northern Ireland

Northern Ireland will have different rules from UK. The following requirements will apply to manufacturers wishing to place medical devices on the Northern Ireland market:

• The EU MDR and EU IVDR will apply in Northern Ireland from May 26, 2021, and May 26, 2022, respectively.
• The CE marking will continue to be required.  In addition, the UKNI marking will be required if a UK Notified Body undertakes mandatory third-party conformity assessment.
• After the transition period, certain medical devices, including in vitro diagnostic medical devices (IVDs), placed on the Northern Ireland market will need to be registered with the MHRA.  Class I devices and general IVDs placed on the market by Northern Ireland manufacturers and Authorised Representatives based in Northern Ireland must be registered. For other device risk classes, there will be a grace period for registering.
• When placing devices on the Northern Ireland market, UK-based manufacturers will need to appoint an EU Authorised Representative.

Access Consortium (ACSS)

The MHRA has joined the Australia-Canada-Singapore-Switzerland (ACSS) Consortium (now known as the Access Consortium). Companies that submit applications to some or all of the five Access countries may benefit from having their products evaluated for marketing in those countries simultaneously with reduced evaluation times. The Access Consortium will update the guidance for industry on how to apply to have products considered for marketing authorization across the five-member countries, including the UK.

Find out more

QNET Ltd. can provide UKRP services if your devices are placed on the UK market. To discuss your business needs in more detail, please contact QNET Ltd. This email address is being protected from spambots. You need JavaScript enabled to view it..

Depending upon client company needs, we offer the following services:

• We assist companies in understanding and complying with European and UK medical device requirements, including data entry into Eudamed and the MHRA register
• As UKRP service provider we support manufacturers in registering their medical devices into the MHRA register.
• We contacting designated notified bodies and or UK Approved Bodies to carry out activities related to the CE or UKCA marking process.
• We provide serving as the official contact with European and UK authorities.
• If a medical device is intended for clinical investigations, notifying applicable national competent authorities.