The new article highlights aspects related to changes to medical device registration and also describes in detail the public register of medical device manufacturers.
The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority, has published a guidance document dedicated to the registration of medical devices. The document provides an overview of the applicable regulatory requirements as well as additional clarifications and recommendations to be considered 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 they are not intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Making Changes to the Registration
The scope of the guidance covers, inter alia, aspects related to changes to the existing registration and the way they should be introduced. First of all, the authority encourages the registration holders to make changes without undue delay in order to ensure the registration information is correct and up-to-date. The appropriate submission could be filed via the authority’s electronic service, the Device Online Registration System (DORS), using the account of the registration holder. The authority also mentions that within the last few years, the scope of information to be provided by the registration holders and the level of detail the authority expects to receive have increased. For instance, now the registration holders would also be expected to provide conformity assessment documents.
For some of the changes, an additional fee would apply. This includes changes to:
- Company name;
- Adding devices to […] registration record or the registration record of manufacturers [the applicant] represents;
- Status of an IVD, for example, a change from “performance evaluation” to “new—the authority mentions that in such a case, a new registration will be required for the in vitro diagnostic medical device in question;
- Change of role from Authorized v.v. Representative to UK Responsible Person or v.v (fee chargeable per represented organization);
- Change of UK Responsible Person;
- Adding new or additional represented manufacturers;
- Uploading new Letters of Designation for represented manufacturers.
The document further outlines the scope of changes for which an additional statutory fee described will not apply. For instance, the said fee will not apply for the following changes:
- Application for the renewal of the existing registration;
- Changes to contact details of the registration holder;
- Adding details and products to an existing medical device registration
- Having some of the products removed from registration;
- Updating registered device and product fields that were not populated at the time of registration;
- Uploading and linking new conformity assessment and self-certification declaration documents to registered devices;
- Adding or deactivating importers
Registration with Expired CE Certificate
The document also provides additional clarifications with respect to the registration of medical devices for which a CE certificate has expired or is about to expire. The authority mentions that, in accordance with the transitional arrangements, the certificates issued under the old regulatory framework (the Directives) could have limited use for the purpose of medical device registration. In particular, such certificates can be relied on for placing a medical device on the Northern Ireland and Great Britain markets until specific dates set forth by the respective regulations.
Class I Device Registration
According to the guidance, there are certain specific aspects associated with the registration of Class I medical devices—in particular, the ones that are Class I reusable surgical instruments under the Medical Devices Directive or the ones that are unclassified from Class I. The respective matters are addressed in detail in a separate guidance document developed and published by the authority. In certain cases, the involvement of a notifying Body will be required in order for the registration of such products to be completed.
In order to ensure transparency and access to information regarding the parties responsible for medical devices allowed for marketing and use in the UK, a register of medical device manufacturers has been introduced: the Public Access Registration Database (PARD). As explained by the MHRA, the details of the manufacturer to be included in the said register are:
- Manufacturer name;
- MHRA Reference (account) number;
- Devices registered with MHRA by Medical Device Type (Global Medical Device Nomenclature (GMDN) Term);
- 5-digit GMDN Code.
In the event of a UK Responsible Person or Northern Ireland Authorized Representative being appointed, they would also be mentioned in the register.
The authority also mentions that the register will not provide details about the IVD products that are currently subject to performance evaluation, nor will it provide the brand, trade, or proprietary names used to market the products.
Should it appear that the registration is not visible in the aforementioned register, the party responsible for the device in question should access the appropriate account and update the information accordingly.
In summary, the present MHRA guidance highlights certain specific aspects related to the registration of medical devices necessary for the products to be allowed for marketing and use in the UK. The document describes the approach to be applied in the case of changes to the product and the information associated with it and also explains the main principles of the public register introduced in order to ensure transparency and proper access to the information about medical devices and entities responsible therefor.
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