The new article highlights the aspects related to placing certain medical devices on the market with the respective CE certificates expired or expiring soon.
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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 reusable Class I / upclassified medical devices, as well as registration reliant on expired/expiring CE certificates.
The document is intended to provide an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto.
At the same time, provisions of the guidance are non-binding in their 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 and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding changes to the underlying legislation.
In particular, the document describes in detail different scenarios of registration reliant on CE certificates that are to expire shortly or have already expired.
Certificate Expired – Device Registered
The first scenario describes the situation when the CE certificate for a medical device already registered with the MHRA expired prior to 20 March 2023.
In such a case, a party responsible for the product in question should access the appropriate account in the National Medical Device Registration System (DORS) and complete the following steps:
- Remove (unlink) certificates that have already expired;
- Submit a declaration on applicability on CE certificate validity extension;
- Indicate the expiration date based on the abovementioned declaration and new validity date
- Indicate details of the existing CE certificate, including its number.
- Provide details of the EU-notified body involved.
The authority also mentions that the date when the certificate has expired cannot be updated, consequently, if the certificate associated with the product has expired, a responsible party won’t be able to take any further actions unless the above steps are completed.
Certificate Expired – Device Not Registered
The second scenario described in the guidance applies to situations when the product in question relies on the CE certificate that has already expired and is not registered with the authority.
In such a case, the “Add Devices using GMDN” function should be used.
The party responsible for a medical device would also have to provide a declaration regarding the extended validity of the CE certificate, as well as additional information about the notified bodies involved.
The document also describes the approach to be applied in similar scenarios with respect to the products with associated certificates expiring after 20 May 2023.
Upclassified Class I Medical Devices and Class I Reusable Surgical Instruments
The scope of the guidance also covers the regulatory matters related to upclassified Class I medical devices and Class I reusable surgical instruments intended to be marketed and used in the UK.
First of all, the authority mentions that by the applicable regulations, upclassified Class I devices stand for the ones ‘for which the conformity assessment procedure under Directive 93/42/EEC did not require the involvement of a notified body, for which the declaration of conformity was drawn up before 26 May 2021 and for which the conformity assessment procedure under EU MDR requires the involvement of a notified body.’
Apart from that, the new Regulation also provides the requirements for Class I reusable surgical instruments.
According to the guidance, to rely on the expired CE certificate when placing the abovementioned devices on the market, a party responsible for the products should ensure that the below conditions are met:
- Those devices continue to comply with Directive 93/42/EEC, as applicable
- There are no significant changes in the design and intended purpose
- The devices do not present an unacceptable risk to the health or safety of patients, users, or other persons, or to other aspects of the protection of public health.
Apart from the above, additional steps are to be taken to ensure compliance with the applicable regulatory requirements, namely:
- Provide evidence for proper implementation of the quality management system – by 26 May 2024
- Confirm a formal application submitted to a notified body – by 26 May 2024
- Provide confirmation of the agreement concluded between the medical device manufacturer and the respective notified body – by 26 September 2024
The authority further explains that in the case of unclassified Class I medical devices and Class, I reusable surgical instruments already registered with the authority with a self-declaration, no further steps are required for the time being to ensure compliance with the applicable regulatory requirements.
The last scenario described in the guidance applies to situations when upclassified Class I medical devices and Class I reusable surgical instruments are not yet registered with the authority.
According to the document, such products are eligible for registration with a self-declaration within the timeframes outlined in the guidance.
This also applies to non-sterile, non-measuring Class I reusable surgical instruments. For this purpose, the aforementioned registration system – DORS – should be used.
In summary, the present MHRA guidance highlights specific aspects associated with the regulatory status of certain medical devices during the transitional period.
The document describes in detail the steps to be taken by the parties responsible for medical devices to ensure compliance with the applicable regulatory requirements and be allowed to market their products in the UK.
Sources
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1172594/Guidance_on_registration_of_certain_medical_devices.pdf
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