UKCA and CE marking – an update from Vygon UK
Since 1 January 2021, there have been a number of changes, introduced through secondary legislation, to how medical devices are placed on the market in Great Britain. At Vygon, we have been monitoring how these recertifications will affect our customers and products - providing regular updates on timings and what they mean.
Read our blog, Transitioning from Medical Device Directive (MDD) CE marking to Medical Device Regulation (MDR), to find out more.
In this blog, we give an overview of the regulations in effect, alongside the latest MHRA (Medicines and Healthcare products Regulatory Agency) updates.
UKCA (UK Conformity Assessed) and CE marking
Introduced at the start of 2021, the aim of UKCA marking was to replace CE marked goods – a quality standard which approves the sale of products in the European Economic Area (EEA).
The UKCA mark demonstrates that products comply with Great Britain’s product safety regulations. Initially, UKCA was to become mandatory certification on products by the start of 2022, however, this deadline was reassessed in 2021, and extended to December 2024.
This July, the MHRA announced that CE marked medical devices would continue to be accepted on the Great Britain market beyond 30 June 2023.
The MHRA cited ‘this measure aims to support the ongoing and safe supply of medical devices within Great Britain and facilitate a smooth transition towards a future strengthened regulatory framework for medical devices.
‘It is the first statutory instrument in a series that are planned to implement the strengthened framework. Next in the series, the MHRA intends to lay a statutory instrument later this year that will put in place enhanced post-market surveillance requirements.
‘Core aspects of the future framework for medical devices are intended to apply from 1 July 2025. This timeline is subject to ongoing review as the MHRA continues to monitor feedback from external stakeholders, for instance, on the capacity of conformity assessment bodies.’
CE marked medical devices may be placed on the market in Great Britain, aligned with the following timelines:
- Until the expiry of the CE certificate or 30 June 2028 (whichever is sooner), for general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (AIMDD) with a valid declaration and CE marking.
- Upon expiry of the CE certificate or 30 June 2030 (whichever is sooner), for in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (IVDD).
- Until 30 June 2030 for general medical devices including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR).
Additionally, all medical devices, including in vitro diagnostic medical devices (IVDs), custom-made devices and systems or procedure packs, need to be registered with the MHRA before they are placed on the market.
An infographic created by the MHRA provides a breakdown of the timelines for placing CE marked IVDs on the Great Britain market and can be viewed here.
Vygon UK’s UKRP status
Medical device manufacturers based outside the UK who wish to place a device on the market in Great Britain, need to appoint a single UK Responsible Person (UKRP) for all their devices, who will act on their behalf to carry out specified tasks, such as registration. As UKRP, Vygon UK is providing this service to its subsidiaries, and suppliers who require it.
Within the UKRP role, Vygon UK is closely managing all protocols to ensure , such as uploading signed letters by the legal manufacturer, to the MHRA database, whilst observing the CE certificate timelines. This includes CE certificates which have already expired and those which are still in date but will expire before 2028.
Where Vygon is acting as an UKRP for manufacturers outside of the UK, this process has already begun and will continue as letters are received from the legal manufacturers. For any other devices where Vygon is not the UKRP, we can advise the legal manufacturer on this new process.
It is important to note that this update does not affect the Vygon GmbH products under a derogation from the MHRA. This derogation is in place as the notified body we previously worked with is no longer recognised in the EU or the UK. As such, we will continue to apply for the derogation, until MDR certificates for the products are obtained.