In order to sell medical devices on the UK market, the manufacturer shall register their medical devices with the UK competent authority (MHRA). To successfully complete the registration process, manufacturers must provide, among other documents, a copy of any conformity assessment certificates or self-certification conformity declarations, as applicable. Do not forget that these certificates have an expiration date!
[/vc_column_text]What are the implications?
If the manufacturer does not update the Conformity Assessment Documents, the registration of any devices and all products linked to the mentioned documents will no longer be active! This will prevent the manufacturer from shipping those devices after the certificate’s expiry date and until the manufacturer provides a new certificate of conformity.
Nevertheless, existing products already placed on the market prior to the expiry date may not be affected by this and can continue to be sold.
To sum up, manufacturers will not be able to lawfully place their devices on the UK market with an expired conformity assessment certificate, given it is a legal requirement to hold an active registration with the MHRA!
Role of the UK RP
UK RP must ensure that all information registered with the MHRA is accurate and up to date. In this sense, the UK RP must modify the registration with the MHRA in case a new version of the expired certificate becomes available. Otherwise, the devices will be permanently removed from the database.
UK Responsible Person’s task is to monitor the compliance of devices based on the end of the transition period of the MHRA device registration, the CE certificate expiration date, or the 30th of June 2023, whichever comes first.
Obelis, as your UK RP, will inform you in case of soon-to be-expired Certificates and update the UK database to allow the continuous sale of your devices!
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Camila Pandiani
02.03.2022
Regulatory Affairs Department
Are you an Medical Device manufacturer wishing to market your devices on the UK market? Contact Obelis UK, your UK Responsible Person today!
References:
MHRA. (2020). Guidance. Regulating medical devices in the UK. Retrieved on 02/03/2022 from: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk.