The article provides a brief overview of the way medical devices should be registered when placed on the UK market.
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The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority in the sphere of healthcare products, has published updated guidance dedicated to the registration of medical devices to be completed in order to place them on the market. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be followed by medical device manufacturers and other parties involved in order to ensure compliance. At the same time, provisions of the guidance are non-binding in their legal nature, and are not intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding changes to the underlying legislation.
The document describes in detail the way medical devices should be registered with the MHRA in order to be allowed for marketing and use in Great Britain and Northern Ireland. The initial version of the guidance was published earlier in 2020.
Regulatory Background
Under the general rule, any and all medical devices intended to be marketed and used in the UK should be subject to registration before being made available to customers. This applies to general, in vitro diagnostic (IVD), custom-made devices, as well as systems and procedure packs. Furthermore, all the aforementioned products should comply with the requirements set forth under the Medical Devices Regulations 2002 (UK MDR 2002). The authority additionally emphasizes that the regulatory requirements to be applied when placing such products on the market in Northern Ireland would be different.
The party responsible for a medical device is also responsible for ensuring the information provided to the authority with respect to the product in the course of registration is correct, accurate, and up to date.
It is also important to mention that registration itself does not constitute any form of approval or accreditation by the authority. Hence, parties responsible for medical devices are not allowed to use the authority’s logo or make any claims regarding the product being approved by the authority in any of the documents accompanying the device or marketing materials.
The authority also reserves the right to request additional information regarding the product, should it be reasonably necessary to assess the safety and effectiveness of the product subject to review, as well as its compliance with the applicable regulatory requirements. Upon request, the party responsible for a medical device should provide additional documentation demonstrating the product’s compliance with the applicable regulatory requirements set forth by the UK MDR 2020.
Registration Scope
The document further describes in detail the scope of products subject to registration and also provides additional information about the regulatory status of the parties involved in operations with medical devices.
Under the general rule, registration requirements will be triggered in the case of:
- Class I, IIa, IIb, or III devices being manufactured;
- Class I, IIa, IIb, or III devices being refurbished or re-labeled with the company’s own name;
- Any system or procedure pack containing at least one medical device;
- Custom-made devices;
- IVDs manufactured;
- IVDs undergoing performance evaluation.
Registration Basics
Should the manufacturer responsible for a medical device intended to be marketed in the UK be based outside the UK, the appointment of a single UK Responsible Person will be required. Once appointed, a UK Responsible Person will have all the responsibilities of a medical device manufacturer as set forth under the applicable UK regulations. At the same time, it is important to mention that the registration requirements do not apply to distributors or suppliers. The parties interested in importing medical devices should duly notify the original manufacturer or its authorized representative about such intentions, while the manufacturer or its authorized representative would have to inform the authority about the importation and provide the details of the importer involved.
Registration Specifics: Northern Ireland
The document also covers aspects related to the registration of medical devices intended to be placed on the market in Northern Ireland. Should it be the case, an interested party should notify the authority accordingly and follow the relevant requirements, which would be different depending on where the manufacturer is based. In particular, the applicable regulations provide the following:
- Non-UK manufacturers are not required to appoint a UK Responsible Person for the purpose of placing medical devices on the Northern Ireland market. Manufacturers based outside Northern Ireland or the EU are required to appoint an EU or Northern Ireland-based Authorized Representative if they wish to place devices on the Northern Ireland market.
- Manufacturers in Great Britain must designate an authorized Representative based in the EU or Northern Ireland in order to place a device on the Northern Ireland market. When an EU-based authorized Representative is appointed, the Great Britain-based manufacturer must register all device classes other than Class I devices and general IVDs (that are not for self-testing) with the MHRA.
The authority also mentions that in the case of an authorized representative based in Northern Ireland, registration with the MHRA will be required.
Special rules also apply to custom-made medical devices intended to be used in Northern Ireland. In accordance with the applicable legislation, such products should be registered with the UK authority within 28 days from the date they are placed on the market.
In summary, the present MHRA guidance provides an overview of the applicable regulatory requirements for the registration of medical devices intended to be marketed and used in the UK. The document also pays special attention to the specifics of registration for marketing in Northern Ireland.
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