This article addresses the aspects related to the extensions to the timelines introduced in order to allow marketing products before compliance with the new regulatory requirements will be achieved.
Table of Contents
The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published a guidance document dedicated to the registration of certain medical devices which are reusable Class I devices, upclassified Class I devices, and/or reliant on expired/expiring CE certificates.
The approach described in the guidance is intended to ensure the uninterrupted availability of medical devices and prevent supply shortages during the transitional period.
Regulatory Overview
The authority mentions that the EU has extended the validity of certain Directive 93/42/EEC on medical devices (EU MDD) and Directive 90/385/EEC on active implantable medical devices (EU AIMDD) certificates.
The present guidance describes in detail the way the parties responsible for medical devices may rely on such certificates when applying for registration of their products to be allowed for marketing and use in the UK.
The document provides an overview of the said transitional arrangements, as well as additional clarifications and recommendations associated thereto in order to assist medical device manufacturers and other parties involved.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they 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 regulations.
End Date
The scope of the guidance covers, inter alia, the aspects related to the end date for acceptance of CE-marked medical devices on the GB market.
According to the document, the acceptance of CE certificates has been extended in order to ensure uninterrupted availability of medical devices for the period of time the parties responsible thereto would need to achieve compliance with the new legal framework.
In particular, the following timelines apply:
- A general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE mark can be placed on the GB market up until the sooner of expiry of the certificate or 30 June 2028;
- In vitro diagnostic medical devices (IVDs) compliant with the EU IVD directive (IVDD) can be placed on the GB market up until the sooner of expiry of the certificate or 30 June 2030, and
- General medical devices compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the GB market up until 30 June 2023.
Thus, the extended timeframes described hereabove would allow medical devices to be placed on the market for a longer period of time, necessary for the parties responsible thereto to take the steps in order to achieve compliance with the new regulatory regime.
At the same time, the authority additionally emphasizes that custom-made products under the Directives are falling outside the scope of the above extensions and could no longer be marketed in GB. At the same time, such products could be registered under the national legal framework set forth by the UK MDR – as explained by the authority, the requirements set forth therein are equivalent to the ones set forth in the respective EU directives.
Special rules would also apply with respect to certain Class I medical devices and general IVDs, for which the involvement of a notified body was not required under the Directives.
Furthermore, it is important to mention that the above approach could not be applied if the certificate for the device in question has already expired.
The authority also announces the new, more strict, post-market surveillance requirements to be developed and introduced in mid-2024.
Previously Expired Certificates: Key Points
The guidance also describes the approach to be applied with respect to medical devices for which the CE certificates have already expired (provided, however, such certificates were valid on 26 May 2021).
In such cases, the party responsible for a product would have to submit a declaration letter confirming compliance with the necessary conditions for the extension of the certificate, namely:
- The manufacturer has a signed contract with the notified body that pre-dates the original expiry of the certificate, or
- If no such contract was signed at the date of expiry, then confirmation that the manufacturer has been granted a derogation from the conformity assessment procedures under Article 59 of EU MDR or that they have been given a period of time to carry out conformity assessment in accordance with Article 97 of EU MDR (Chapter 7, Sec 8)
In order to assist the parties involved, the authority also provides a template of the abovementioned declaration letter.
In summary, the present MHRA guidance describes in detail the transitional arrangements allowing medical device manufacturers to continue supplying their products to GB while taking necessary steps to achieve compliance with the new legal framework.
This includes inter alia, an extended period during which the certificates issued under the old regulatory regime would still be accepted.
The document also provides clarifications on the situations when the certificate issued under the directives has already expired, but there is an intention of the party response for the product to continue supply under the new framework.
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