FAQs

From 1^st January 2021, MHRA has taken on the responsibilities for the medical devices on Great Britain market (England, Wales and Scotland) that had been undertaken through the EU system.

“The Medicines and Healthcare products Regulatory Agency” also known as MHRA is the competent authority in the UK for the registration of medical devices.

It performs market surveillance of medical devices on the UK and take decisions over the marketing and supply of devices in the UK. The MHRA is also responsible for the designation and monitoring of UK Conformity Assessment Bodies (UK CAB) / UK Approved Bodies.

Manufacturers of medical devices wishing to place their products on the Great Britain market (England, Scotland and Wales) will first need to register with the MHRA. And MHRA will only register manufacturers or UK Responsible Person (UKRP) that have a place of business in the UK. So, if you are a manufacturer based outside the UK, then you cannot directly register with MHRA. Similarly, your EU Authorized Representative cannot register you with MHRA. Therefore, first of all you must appoint an UKRP, who’ll register your devices with MHRA on your behalf for Great Britain market.

From 1^st January, 2021, medical device manufacturers already registered with the MHRA, they must make a new legally binding agreement with UKRP as per new UK regulation; and UKRP must update the data at MHRA portal as per new UK regulation.

The Global Medical Device Nomenclature (GMDN) is a list of generic names issued by GMDN Agency; used to identify all medical device products. (For further details visit GMDN website)

MHRA requires manufacturers to provide GMDN codes for their device registration.

Following are the obligations for manufacturers based outside UK to place their devices in Great Britain market:

• Ensure devices’ compliance with the relevant UK legislation(s) and carry out applicable conformity assessment procedure.
• Draw-up and keep up-to-date technical documentation and implement post-market surveillance system. And provide UK Responsible Person (UKRP) a copy of the technical documentation, a copy of the UK Declaration of Conformity (UK DOC) and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA.
• In case, manufacturer consider or have reason to believe that device(s) that are placed in the Great Britain market is/are not in conformity, then manufacturer will;
  • immediately take the necessary corrective action to bring that device(s) into conformity, to withdraw it or to recall it, as appropriate;
  • inform the distributors of the device in question, the UK responsible person (UKRP) and importers accordingly;
  • where the device(s) present(s) a serious risk, immediately inform the MHRA and, where applicable, the UK Approved Body that issued a certificate for the device(s), in particular, of the non-compliance and of any corrective action taken.
• Ensure that UK Responsible Person (UKRP) has permanently available all the necessary updated information / documentation for the devices to be placed in the Great Britain market and for which they have been designated.
• Immediately provide UK Responsible Person (UKRP) with any kind of document, information, device sample etc. requested from MHRA for inspection.
• Ensure to place only those devices in pertinent market that have been registered with MHRA via UK Responsible Person (UKRP).
• Affix UKCA marking as per the provided guidelines.

Manufacturers must have technical documentation of their devices that must enable the conformity with the relevant UK regulatory requirements. The precise content will vary according to the device in question and the UK legislation concerned, but generally it must at least address the following:

• Device description along with its intended use
• Technical details like technical drawings (also depicting the scheme of assembly, if required), bio compatibility of material(s) used, critical test reports, manufacturing processes, list of applicable harmonized standards or other relevant technical standards/specifications with which the device complies
• Information to be supplied by the manufacturer like label, instruction for use, etc.
• UK Declaration of conformity (UK DOC)
• Essential requirement checklist
• Clinical evaluation / clinical investigation
• Risk management
• Validation(s)
• Post-production activities like post-market surveillance, vigilance, etc.

It is important to note that pertinent technical documentation can be requested by the MHRA at any time to check conformity of manufacturers’ device with the relevant UK regulatory requirements. Moreover, this documentation is also required to be retained for the period of at-least 10 years after the device is placed on the Great Britain market.

The UKCA (UK Conformity Assessed) mark is a new Great Britain product marking that will be used for medical devices, being placed on the Great Britain market.

Following is the route to UKCA mark,

UKCA mark to be placed on the following,

• Device itself
• Packaging
• Manuals / IFU / Label
• Other supporting literature.

• UKCA marking must only be placed on a product by you as the manufacturer.
• Affixing the UKCA marking, you as a manufacturer take full responsibility for your product’s conformity with the relevant UK legislative requirements.
• UKCA marking must only be used to depict product’s compliance to the relevant applicable UK legislation.
• Never affix any marking or sign that may wrongly interpret the meaning or form of UKCA marking to third parties.
• Never attach other markings on the product that may affect the visibility, legibility or meaning of the UKCA marking.
• Never affix UKCA marking on the products; where there is no specific requirement to do so in the relevant UK legislation.

While affixing UKCA marking, one must make sure that:

• in case of reducing or enlarging the size of marking, the letters of the marking must be in proportion to the version set out above.

Download UKCA mark image files (fill) (ZIP, 818KB)

Download UKCA mark image files (outline) (ZIP, 2.03MB)

• the height of the marking is to be at least 5mm – except when a different minimum dimension is specified in the relevant UK legislation.
• the marking is to be easily visible and legible.
• make sure to affix permanent UKCA marking on products i.e. cannot be removed.

Under the Medical Devices Regulations 2002; MHRA can issue a:

• compliance notice to formally outline perceived offences and request you to correct a non-compliance.
• restriction notice, in order to restrict the availability of a particular medical device, or of devices of a particular class or description.

If MHRA considers that you have committed a serious offence by failing to comply with these regulations or the conditions of a notice issued to you then you may be subject to prosecution. Prosecution could carry a penalty of an unlimited fine and/or 6 months’ imprisonment.