UK Medical Device Registration

Unlocking Success: Navigating Medical Device Registration and Vigilant Post-Market Surveillance in United Kingdom

Regulatory Authority: Medicines & Healthcare products Regulatory Agency MHRA

The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK.

MHRA prioritizes patients throughout the lifecycle of medicines and healthcare products in the UK. They use science and data to inform decisions, ensure safety, and promote medical innovation.

Their responsibilities include ensuring medicines, medical devices, and blood components meet safety standards, securing a safe supply chain, promoting international standardization, educating the public and healthcare professionals about risks and benefits, enabling innovation, and collaborating with partners to ensure access to safe medicines and protect public health.

Link for Regulatory Authority: https://www.gov.uk/government/organisations/department-of-health-and-social-care

Local Regulation: UK MDR 2002

Link for Regulation: https://www.legislation.gov.uk/uksi/2002/618/contents/made

Overview of Regulation in UK:

The UK Medical Device Regulations 2002 (UK MDR 2002) outline the requirements for manufacturers of medical devices to legally place them on the market. These regulations ensure the devices are safe and effective for patients, the public, and healthcare professionals. Understanding these regulations aids in planning device development effectively and avoiding resource wastage. Compliance with the law boosts public trust, adoption rates, and innovation investment. Non-compliance can result in prosecution, device removal from the market, delays in development, and damage to the manufacturer’s reputation.

Classification: Class I, IIa IIb and III

Listing or Registration Requirements:

• If the manufacturer is based outside of the UK, they must appoint a single UK Responsible Person to take responsibility for all of their medical devices.
• Manufactures need to submit CE, DoC, IFUs and Labels
• They also need to submit LoA

Documents Required:

• Manufacturer details:
  • legal entity name and address as it appears on the device labelling/packaging
  • company type e.g. limited company, sole trader
  • administrative contact (you can have up to 15 people with access)
  • a letter of designation for UK Responsible Persons (where applicable). This must be a legal contract, stating that you are the exclusive UK Responsible Person acting for the manufacturer and specifying the mandatory tasks you are contracted to undertake on behalf of the manufacturer. The mandatory tasks that must appear in the designation contract can be found in our regulatory guidance for UK Responsible Persons.

• Device details:
  • which legislation applies
  • the class of device you are registering
  • Global Medical Devices Nomenclature (GMDN) code and term to describe your device
  • Basic UDI-DI (if applicable)
  • medical device name (brand/trade/proprietary name)
  • model or version detail
  • catalogue/reference number
  • UDI-DI (if applicable)
  • UK Approved Body (or EU Notified Body) where applicable
  • attributes such as sterility, contains latex, MRI compatible

Registration Timeline:

• 4 months (until 30 April 2021): active implantable Medical Devices, Class III Medical Devices, Class IIb implantable Medical Devices, IVD List A products;
• 8 months (until 31 August 2021): Class IIb non-implantable Medical Devices, Class IIa Medical Devices, IVD List B products, self-test IVDs;
• 12 months (until 31 December 2021): Class I devices, general IVDs.

Registration Fee: The MHRA charges a fee of £240 for each registration. Companies can submit up to 100 device applications under that £240 fee, if all device families are registered at the same time.

License Validity: Licenses are valid as long as the validity of the CE Mark. Licenses for Class I devices do not expire.

The UKCA marking does not have any time limit – it is a declaration made at a point of time. Some certificates that are required for UKCA (as with CE Marking) may have time limits. For example, GAR type examination certificates are valid for a maximum of 10 years. This is the same under UK law.

Special Labelling Requirements: Medical devices placed on the Great Britain market must have a UKCA marking or a CE marking, depending on which legislation the device has been certified under. Where relevant, the number of the Approved Body or Notified Body must also appear on the label.

Vigilant Post-Market Surveillance:

Adverse incidents involving medical devices in the UK must be reported to the MHRA. Manufacturers must submit vigilance reports when incidents occur and take appropriate safety action when necessary.

The medical device vigilance system is responsible for notifying and evaluating adverse incidents and field safety corrective actions (FSCA) involving medical devices. The system is detailed in MEDDEV 2.12/1 rev 8 and additional guidance under ‘Post-Market Surveillance’, outlining what, how, and when to report adverse incidents involving medical devices in the UK market.

Additional Comments:

• Any changes to registrations are made, a £100 statutory fee will apply per application.
• The CE marking shall be used and recognized until 30 June 2023, as well as CE mark certificated issued by Notified Bodies established in the European Economic Area (EEA).
• Moreover, from 1 July 2023, to place a device on the UK market, it will also be necessary to meet the requirements for affixing the UKCA mark on the device.

Who should make this communication:

• Manufacturer
• Authorized Representative

When to make this communication: Before placing a medical device into the market.

How OMC Medical can assist you with the process

• Act as your Authorized representative

Why Choose Us

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]