Laura Friedl-Hirst, senior consultant and managing director of LFH Regulatory, reviews the latest news and speculation on the UK Regulatory Framework.
It feels like a lifetime ago since the UK’s referendum on membership of the European Union (EU) in June 2016, with the UK leaving the bloc in January 2020.
The UK MDR 2002 (SI 2002 No 618, as amended) has been of great importance in the UK. UK legislation is closely aligned with and currently follows EU directives:
- Medical Device Directive 93/42/EEC (MDD)
- Active Implantable Medical Device Directive 90/385/EEC (AIMDD)
- In Vitro Diagnostics Directive 98/97/EC (IVDD)
The Directive has been converted into a Regulation, with the In Vitro Diagnostic Medical Devices Regulation (IVDR), EU 2017/746 replacing IVDD and the Medical Devices Regulation (MDR), EU 2017/745 improving MDD and AIMDD.
Following the transition period, EU MDR2017/745, and EU IVDR 2017/746 have not been transposed into British legislation. Since Brexit, Northern Ireland and Great Britain have diverged in terms of their priorities. Northern Ireland has implemented and continues to comply with EU legislation, while Great Britain is currently complying with the EU MDD/IVDD/AIMDD (where applicable), or the MDR/IVDR and/or the UK MDR with a view to developing the new legislation currently being drafted.
So, what does Brexit mean for medical devices and manufacturers in Great Britain?
On 26 June 2022, the Medicines and Healthcare Products Regulatory Agency (MHRA) published its response to the consultation on “future regulation of medical devices in the UK”, which outlines future changes to the UK’s medical device legislation going forward. The five pillars on which the UK MDR will be implemented are set out:
- Strengthening the MHRA’s operational capacity
- Making the UK a focus for innovation
- Tackling health inequities and reducing bias throughout the life cycle of medical products
- Harmonized rules that support businesses through entry procedures based on agreements with the EU and international standards
- Branding the UKCA as a global model.
Initially, the UK MDR was due to be implemented in July 2023, but the MHRA extended that period by 12 months. The draft is expected in mid-2023 and will be followed by a two-month consultation.
Transitional arrangements for the UK MDR are needed to facilitate the transfer of equipment to Great Britain under the transitional arrangements but are subject to parliamentary approval. Devices can be placed on the market in Great Britain in the following order:
- Medical devices that comply with MDD or AIMDD with a valid declaration and CE mark can be placed on the market in Great Britain until the expiry date of the certificate or 30 June 2028.
- in vitro diagnostic medical devices (IVDs) compliant with the IVDD can be placed on the market in Great Britain until the expiry of the certificate or 30 June 2030 and,
- Conventional medical devices, including custom-made devices, that comply with the EU MDR and IVDs compliant with the IVDR can be placed on the market in Great Britain until 30 June 2030.
Class I medical devices and most IVDs under the EU MDD or IVDD, for which conformity assessment did not require a notified body, can be placed on the market in Great Britain if exposure to a notified body is required under the EU MDR or IVDR. .
The government plans to introduce legislation later this year to strengthen post-market inspection requirements before they are implemented. For now, the emphasis is on more robust, less time-consuming, more detailed requirements for PMS systems including transport reporting, FSCAs and new requirements for custom-made equipment – expected to come into force from mid-2024.
Producers may have time to work to meet UK regulatory requirements but without draft legislation, the requirements are unclear.
By May 2023, UK Accredited Bodies are guaranteed to be accredited by the UKCA, but this is subject to the UK MDR system which varies according to their capacity. Notified Bodies cannot certify according to the new requirements because these are not yet in place, but not many have taken up the UKCA certification process compared to the EU. It is not clear whether the existing EU Notified Bodies will increase their certification capacity or whether they are waiting to write documents.
With the current difficulties in getting devices approved by the Notified Bodies in the EU under the EU MDR and IVDR, the concern will be on the UK Approved Body resource to allow manufacturers to change in time, but the MHRA is looking at strong development and implementation. new requirements for Accredited bodies.
With no documentation currently available on the new UK MDR with manufacturers complying with the UK MDR 2002 or the EU Directive framework, it is unclear what steps companies will need to take to submit to Great Britain. Hopefully, this will change soon.
LFH Regulatory will exhibit on Stand A31 at the Med-Tech Innovation Expo. To register for FREE, visit www.med-techexpo.com. Laura Friedl-Hirst will be part of a live episode of The MedTalk Podcast discussing the latest UK regulatory developments on Day One of the Introducing Health-Tech Stage.