UKCA and CE Mark
On 1st Augsut 2023 - the UK Government announced extension of CE mark recognition for businesses.
Just after this Announcement, our experts were swamped with phone calls and queries to see whether their Medical Devices were part of this extension.
The UK MHRA is recently on a spree of updating the UK MDR Regulation of 2002. This regulation will see significant amendments and the introduction of new regulatory requirements, which are mentioned in the latest update on the implementation of the future regulations for medical devices.
The Announcement on 1st August 2023 was released by the Department for Business and Trade with the following key points :
- Business department announces indefinite CE mark recognition beyond 2024 deadline
- As part of the government’s drive for smarter regulation, the extension will cut business costs and time required to place products on the market and benefit consumers
- Follows extensive engagement with industry, delivering on a key ask from businesses to ease burdens and boost growth for the UK economy
Medical Manufacturers sighed with relief, hoping this Announcement would allow them to lose the buckle and relax.
But the UK Medicines and Healthcare Regulatory Agency (MHRA) had different plans!
Right after the Announcement – UK MHRA released a statement on CE marking recognition for medical devices and in vitro diagnostics.
The Announcement mentions that The extended recognition of CE marking announced this morning [1st August 2023 by the Department for Business and Trade] does not apply to medical devices or IVDs.
The government has already put in place legislation that amends The Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR) to extend the acceptance of CE marked medical devices on the Great Britain market. More specifically, legislation now enables CE marked medical devices to be placed on the Great Britain market to the following timelines:
- general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of the expiry of the certificate or 30th June 2028
- in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner of the expiry of the certificate or 30th June 2030, and
- 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) can be placed on the Great Britain market up until 30th June 2030.
Medical Device Manufacturers can ‘step off’ the gas paddle on Regulatory Affairs only when they engage with a suitable set of Regulatory and Quality Compliance professionals!
Experts at Medi-Di-Dia are here to support Medical Device Manufacturers with complete Regulatory and Quality Compliance support. From strategy-making to the execution of relevant RAQA requirements, our experts will be your Regulatory Risk Partner.
Contact us by sending an email – mdd@mddltd.com or by filling up our contact form - https://mailchi.mp/4581bff533d0/ukmdr
