The Medicines and Healthcare products Regulating Agency (MHRA) of the UK has updated its guidance for medical device manufacturers initially published in December 2014. In particular, the document provides additional clarifications and recommendations regarding how medical device manufacturers shall register in order to be allowed to market medical devices in the UK.
According to the general rule, in order to be allowed to market its medical devices in the UK, the manufacturer shall register with the MHRA. However, only domestic medical device manufacturers are eligible for registration with the MHRA. Thus, under the new rules, if the manufacturer is based abroad, a UK-based authorized representative shall be appointed to act on behalf of the foreign manufacturer and represent it for all communications with the regulating authority.
The same approach is already being utilized in the European Union, where the manufacturer shall be based within the EU or establish a representation therein. At the same time, due to Brexit, the EU representation would be no longer sufficient to enter the UK market – the authority additionally emphasizes that the manufacturer should be based in the UK itself or duly appoint an authorized representative therein. Moreover, before applying for the registration, the medical device manufacturer shall complete a conformity assessment in order to be allowed to use the CE marking for its products.
It is also important to mention that there are new registration requirements becoming applicable starting from January 1, 2021.
In accordance with the applicable regulations, only the UK-based medical device manufacturers and their authorized representatives could be registered with the MHRA, while the distributors and suppliers are not eligible for such registration.
Before actually placing its medical devices on the market, the manufacturer would also have to submit the documentation demonstrating that the medical device in question meets the requirements set forth by the Medical Devices Regulations.
The scope of the present policy covers medical devices compliant with the following EU-wide regulations:
- The Medical Devices Directive (MDD),
- The Active Implantable Medical Devices Directive (AIMDD),
- The In Vitro Diagnostic Medical Devices Directive (IVDD),
- The Medical Devices Regulation 2017/745 (MDR),
- The In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR).
Placing Medical Devices on the UK Market
The authority also mentions that currently there are two main applicable frameworks: notification-based process and conformity assessment-based one.
According to the guidance, the medical device manufacturer shall duly notify the regulating authority in case of placing on the market the following types of products:
- Class I medical devices manufactured by the entity itself,
- Class I medical devices refurbished or re-labeled with the name of the entity,
- Any and all systems containing at least one medical device as a component thereof,
- Custom-made medical devices,
- In-Vitro Diagnostic medical devices, including the ones undergoing performance evaluation.
With regard to the new regulations (MDR and IVDR), the UK regulating authority finds admissible the applications for the registration of Class I medical devices, and Class A in vitro diagnostic medical devices.
The authority also states that in the case of Class IIa, IIb, III, or active implantable medical devices the appropriate conformity procedure should be carried out. For this purpose, a notified body should be engaged, provided that the type of medical device subject to review falls within the scope of the designation of such a notified body.
UK Authorized Representative
As it was already mentioned before, a foreign medical device manufacturer shall duly appoint an authorized representative in the UK (this requirement becomes applicable under the new framework). An authorized representative shall have a letter of designation in place in order to confirm that it is entitled to represent a respective medical device manufacturer. Such a letter of designation or a contract should indicate the names and contact details of both parties., and also outline the scope of responsibilities and rights of the authorized representative to be granted by the medical device manufacturer. In case if a new authorized representative replaces the one the manufacturer has been cooperating with before, the MHRA would also require to provide a copy of the letter canceling the service with the previously authorized representative.
Registration Requirements in Detail
The MHRA guidance also provides some additional clarifications regarding the particular cases the registration with the regulating authority is required. The document also highlights certain important aspects related to each particular type of medical devices, namely:
- Custom-made medical devices. In case if a custom-made medical device subject to review is an implantable device, the applicant would also have to submit the instructions for use and samples of the labeling.
- System and procedure packs. The mandatory registration rule covers the companies intended to market in the UK the systems and procedure packs containing a general or sterile medical device as a component thereof. For the purpose of such a registration, the applicant shall use the Global Medical Devices Nomenclature (GMDN) in order to ensure the clarity of the description. In particular, the appropriate GMDN terms should be indicated when submitting the application via the online registration system operated by the MHRA.
- In vitro diagnostic medical devices (e.g. reagents, antigens, plasmas, testing kits, etc.). When applying for the registration of such products the Global Medical Devices Nomenclature.
Additional Aspects Related to Registration in the UK
Besides the points described hereinabove, the MHRA guidance on registration-related matters addresses other important aspects to be considered by the parties involved in operations with medical devices. For instance, the authority provides additional clarifications regarding the use of the Device Online Registration System (DORS), which could be used by the medical device manufacturers or their authorized representatives to register their products and maintain the accuracy of records.
The MHRA also mentions that a basic statutory fee in the amount of GBP 100,00 is payable for each new application. The authority also mentions that any change requests are considered as separate applications and thus should be paid accordingly. In order to proceed with the application, the interested entity shall apply for an account with the MHRA that later would be used for all submissions. The authority also mentions that certain changes to its online services are currently in process, but the accounts created previously remain active.
One of the most important aspects covered by the present MHRA guidance relates to the change notification obligations. According to the document, a medical device manufacturer shall duly notify the regulating authority of any changes to:
- The registered address,
- The name of the company,
- The type (legal form) of the company,
- The list of the devices (e.g. addition of a new device),
- The status of an in vitro diagnostic medical device,
- The change of authorized representative.
As it was already mentioned before, under the general rule, the applications for changes are subject to fees payable as described above. However, the MHRA also states that there are certain exclusions, when the fee payment requirement is not applicable, namely:
- The changes to the contact details,
- The addition of products to registered devices, and
- The removal of medical devices or products from the registration record.
Summarizing the information provided here above, the present MHRA guidance describes the most critical aspects related to the registration of medical device manufacturers and their authorized representatives. The document also provides detailed clarifications regarding the eligibility criteria and change notification rules.
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