The article provides a general overview of the regulatory requirements for the registration of new medical devices relying on CE certificates that are either expired or about to expire.
Table of Contents
The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the registration of certain medical devices that are reusable Class I devices, upclassified Class I devices, and/or reliant on expired/expiring CE certificates.
The document is intended to provide additional clarifications regarding the applicable regulatory requirements set forth by the existing legal framework, as well as recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance therewith.
At the same time, provisions of the guidance are non-binding in their legal nature and are 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 amendments to the underlying legislation.
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.
Extended Certificates (Transitional Arrangements): Keypoints
In accordance with the latest revisions of the timelines for achieving compliance with the new regulatory framework set forth by the EU Medical Devices Regulation 2017/745 (EU MDR), the certificates issued under the abovementioned directives would be accepted for a longer period of time.
The intention of this is to prevent shortages in the supply of vitally important medical devices and ensure their uninterrupted availability by extending the period medical device manufacturers can use to take all the necessary measures to achieve compliance with the new legal framework and regulatory requirements set forth therein. It is important to mention that the above extension applies under certain conditions.
Under the initial revision of the transitional provisions, certificates issued under the Directives were supposed to be valid until May 27, 2024. However, the changes to the transitional provisions have been implemented, introducing an extension to the validity period of the said certificates as follows:
- Till December 31, 2027, for higher risk devices (class III and IIb implantable devices except certain devices for which the EU MDR provides exemptions, such as screws and sutures, given that these devices are considered to be based on well-established technologies), this includes systems and procedure packs that contain such class III and class IIb implantable devices.
- Till December 31, 2028, for medium and lower risk devices (other class IIb devices and class IIa, class Im, Is, and Ir devices); this includes system and procedure packs that contain such devices and that do not contain class III and class IIb implantable devices that are covered at point (a) above.
Furthermore, the CE certificates issued under the Directives would remain valid within the timeframes described above, provided they are valid on the day the extension to the timeframes was adopted, subject to the following conditions:
- The length of the extension of the certificate’s validity is the length of the applicable extended transition period under Article 120(3a) of the EU MDR;
- For certificates that have already expired before March 20, 2023, the extended validity is subject to the condition that:
- Before the date of expiry, the manufacturer has signed a contract with a notified body for the conformity assessment of the device in question, or
- A competent authority has granted a derogation from the conformity assessment procedures under Article 59 of the EU MDR or has given the manufacturer a period of time to carry out conformity assessment in accordance with Article 97 of the EU MDR.
The authority additionally emphasizes that the above will not result in notified bodies being required to amend the dates of individual certificates. Moreover, it is also important to mention that the extension described above will not apply with respect to certificates associated with in vitro diagnostic devices regulated under the respective directive.
Jurisdiction-Specific Aspects (Essential Principles)
The document also highlights the specific aspects related to the reliance on the certificates that have expired in Northern Ireland and Great Britain. According to the guidance, the CE certificates that are falling within the scope of the extension of validity described hereabove are acceptable for registration in both these territories. In particular, they could be used in the context of placing medical devices on the market:
- In Northern Ireland – for the entire extended period of validity, subject to the aforementioned transitional arrangements and conditions,
- In Great Britain – for the entire period of validity or until June 30, 2028, whichever date is sooner.
Recommendation By Regulatory Authority
Thus, the authority encourages all the holders of CE certificates subject to extension of validity to update the records accordingly in order to prevent interruptions in the registration and supply of the products.
In summary, the document provides a general overview of the situation with the extension of validity of certain CE certificates issued under the Directives in accordance with the respective transitional provisions set forth by the EU MDR. The guidance outlines the extended validity timeframes and describes the way they should be calculated.
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