Brexit Transition
As the UK has left EU on 1st January 2021, all legal manufacturers are required to register their devices with MHRA as per the given timelines:
| FROM 1 MAY 2021 | FROM 1 SEPTEMBER 2021 | FROM 1 JANUARY 2022 |
|---|---|---|
|
Active Implantable Medical Devices |
Class IIb Non-Implantable Medical Devices |
Class I Medical Devices |
|
Class I Medical Devices |
Class I Medical Devices |
Class I Medical Devices |
|
Class IIb Non-Implantable Medical Devices |
Class IIb Non-Implantable Medical Devices |
Class IIb Non-Implantable Medical Devices |
MHRA have introduced measures which provide that CE marked medical devices may be placed on the GB market to the following overall timelines:
a. general medical devices compliant with the EU medical devices directive (EU MDD) or V3/Jun 2023 3 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 certificate or 30 June 2028
b. 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 certificate or 30 June 2030, and
c. 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 2030.
Our UK personnel are ready to assist in registering your medical device/IVD with the MHRA on behalf of your organisation.
From 30th June 2030 onwards, CE mark will no longer be valid if you wish to market your devices. Therefore, to sell in Great Britain, you must have a UKCA mark, and for Northern Ireland the proper approval is a UKNI designation.
Our regulatory professionals are here to assist you in assessing your regulatory compliance for Brexit.
For further details, please Contact Us