Chapter 1 UK MHRA Administration Information Abstract

1. Administration and Abstract 

MHRA: The Medicines & Healthcare products Regulatory Agency is responsible for operating the UK medical device vigilance system, including conducting market surveillance, enforcing regulations and working with healthcare and regulatory stakeholders in the UK and globally.

While the MHRA does not certify medical devices, the MHRA monitors UK approval bodies and has the power to remove medical devices from the UK market if the MHRA deems them unsafe.

UKCA: short for UK Conformity Assessment, is a UK product mark used for certain goods (including medical devices) sold in the UK market (England, Wales and Scotland).

2. Administrative Regulation

The UKCA marking requirements for medical devices are based on the requirements of the three directives related to the original European Medical Device Directive (EU AIMDD, EU MDD, EU IVDD) and have been amended in conjunction with the UK Medical Device Regulation UK MDR 2002 to make it applicable in the UK.

The existing UK Medical Device Regulations are known as The Medical Devices Regulations 2002 (UK MDR 2002), which covers both MD and IVD.

Basic regulations:

《Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)》；

Before the end of the transition period (after the UK leaves the EU), the following regulations give effect to the following directives in UK law:

①Directive 90/385/EEC on active implantable medical devices (EU AIMDD)

②Directive 93/42/EEC on medical devices (EU MDD)

③Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)

3. Risk Level Classification of Medical Devices 

4. Registration Basis

All Medical Devices, including IVDs, custom devices and systems or software packages, must meet the requirements of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) in the UK to be listed and registered with the MHRA. That is, medical devices must obtain UKCA or CE certificates before entering the UK market. The certificate indicates that the device complies with relevant regulations.

5. Registration Language

English.

6. UK Responsible Person

Manufacturers outside the UK are required to appoint a UK Responsible Person as an authorized representative in the UK to register their products.

①The UK responsible person must provide written evidence that they are authorized by the manufacturer to act as their UK responsible person. The UK representative performs designated tasks on behalf of the non-UK manufacturer in relation to the manufacturer's obligations, which includes registering the manufacturer's equipment with the MHRA prior to the device entering the UK market.

②Importers and distributors do not need to appoint a UK responsible person.

③In addition to the registration requirements, the UK responsible person must also:

a) Ensure that declarations of conformity and technical documentation have been drafted and, where applicable, that the manufacturer has carried out appropriate conformity assessment procedures

b) Upon MHRA's request, provide MHRA with all information and documentation necessary to prove the conformity of the equipment

c) Take any preventive or corrective action in cooperation with the MHRA to eliminate or, where this is not possible, mitigate the risks posed by the equipment

d) Immediately inform the manufacturer of complaints and reports from healthcare professionals, patients, and users about suspected incidents related to their designated devices.

7. Importers and Distributors

①If the UK importer is not the UK responsible person, the importer must inform the relevant manufacturer or the UK responsible person of its intention to import the equipment. In this case, the manufacturer or the UK representative of the manufacturer must provide the MHRA with the details of the importer of the equipment. Further guidance on device registration can be referred.

②Obligations relating to storage, transportation and inspection of equipment labels for CE marking or UKCA marking also apply. The name and address of the importer or distributor need not appear on the label.

Chapter 2 Registration Flow

Official Fees:

The following fees cover MHRA registration only and for products that require a certificate issued by a notified body, the certification fee is not included; The official fee may be subject to change later, and the specific fee standard is subject to the latest information released by the official.

Chapter 3 FAQ

Q: How long does it take for medical device products to be registered in the UK?

A: For low-risk product applications, Class I & General IVDs, the average review time is 2-4 weeks, and the maximum processing time can reach 90 days.

If it is a product that needs Approval Body audit, it needs to be determined according to the specific audit time of different AB.

Q: Does it require a QMS certificate for UK registration of medical devices?

A: A separate QMS certificate is required for medical devices to be registered in the UK.

Q: What are the official fees in the UK?

A: Source of fees: MHRA

https://www.gov.uk/government/publications/mhra-fees/current-mhra-fees).

Q: After the registration of medical devices, if it is found that the authorized representative does not cooperate with the business, can the authorized representative be replaced?

A: Yes, the MHRA allows the manufacturer to change to a new authorized representative.

Q: Can a product be registered by multiple authorized representatives at the same time?

A: No, a product is only allowed to have one authorized representative.

Q: Can the medical device products be changed after completing registration?

A: If the medical device product changes conform to the scope permitted by MHRA, an authorized representative can submit a change application, and after MHRA approval, it can be put into the UK market.

Q: Is Batch Upload available for all GMDN Code combinations?

A: No, batch upload cannot be used for all GMDN Code combinations. The Batch Upload function is only available for a device model with a certain GMDN Code. For example, to register a GMDN Code that includes 50 different device models, you can register these 50 device models using a batch pass.

Q: Does the manufacturer have to reflect the UK RP name and address on the logo and packaging, and is the current logo and packaging valid until 30 June 2023?

A: It is currently in a transitional phase, and if the extension regulations remain unchanged, the EU MDD/IVDD or EU MDR/IVDR device labeling and packaging in the UK will not need to be changed until June 30, 2023. As a result, the current logo and packaging (including the CE marking) will remain valid, while the name and address of the UK RP will be mandatory on the logo and packaging until 30 June 2023.