The UK Regulatory Framework –where are we now?

Laura Friedl-Hirst, principal consultant and managing director of LFH Regulatory, analyses the latest news and speculation on the UK Regulatory Framework.

It feels like a lifetime ago since the UK’s referendum on European Union (EU) membership in June 2016, with the UK exiting the bloc in January 2020.

The UK MDR 2002 (SI 2002 No 618, as amended) has been an integral requirement within the UK. The UK regulation is closely aligned and currently follows the 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)

These Directives have been transposed into Regulation, with the In Vitro Diagnostic Medical Devices Regulation (IVDR), EU 2017/746 superseding the IVDD and the Medical Devices Regulation (MDR), EU 2017/745 superseding both the MDD and AIMDD.

Following the transition period, the EU MDR2017/745, and EU IVDR 2017/746 have not been transposed into British law. Since Brexit, Northern Ireland and Great Britain have separated in terms of their regulatory requirements. Northern Ireland has implemented and continues to follow EU law, whereas Great Britain currently complies with EU MDD/IVDD/AIMDD (where applicable), or MDR/ IVDR and/or UK MDR with the aim to create new legislation currently being drafted.

So, what does Brexit mean for medical device compliance and manufacturers in the Great Britain market?

On 26 June 2022, the Medicines and Healthcare products Regulatory Agency (MHRA) published its response to the consultation on the “future regulation of medical devices in the UK”, indicating future change for UK medical devices regulation going forward. Five pillars on which the UK MDR will be based upon, were established:

● Strengthening MHRA power to act

● Making the UK a focus for innovation

● Addressing health inequalities and mitigating biases throughout medical device product lifecycles

● Proportionate regulation which supports businesses through access routes that build on synergies with both EU and wider global standards

● Building the UKCA mark as a global exemplar.

Initially, UK MDR was due to be implemented in July 2023, but the MHRA extended the timeframe by 12 months. A draft text is expected by the middle of 2023 followed by a two-month consultation.

Transitional arrangements to the UK MDR are required to facilitate supply of devices to Great Britain under the transition measures but is still subject to parliamentary approval. Devices may be placed on the Great Britain market under the following timelines:

● General medical devices compliant with the MDD or AIMDD with a valid declaration and CE marking can be placed be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028

● in vitro diagnostic medical devices (IVDs) compliant with the IVDD can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030 and,

● general medical devices, including custom-made devices, compliant with the EU MDR and IVDs compliant with the IVDR can be placed on the Great Britain market up until the 30 June 2030.

Class I medical devices and general IVDs under EU MDD or IVDD, for which the conformity assessment did not require a Notified Body, can only be placed on the Great Britain market if the involvement of a notified body would be required under the EU MDR or IVDR.

The Government intends to introduce legislation later this year to strengthen post-market surveillance requirements prior to the framework’s implementation. Presently, the emphasis is on more stringent requirements, tighter timelines, information to be covered for PMS systems including trend reports, FSCA’s and new requirements for custom made devices – expected to apply from mid-2024.

Manufacturers may have time to work towards the UK regulatory requirements but with no draft regulation in place, the requirements remain unclear.

As of May 2023, four UK Approved Bodies are certified for UKCA accreditation, but this is under the current UK MDR framework for whom all vary under their certification capabilities. Notified Bodies cannot certify under the new requirements as these do not yet exist, but not many have yet taken up UKCA certification duties compared with the EU. It is unclear if existing EU Notified Bodies will expand their current certification capabilities or whether they are holding out for a draft text.

With the current struggles for certification of devices by Notified Bodies in the EU under the EU MDR and IVDR, the concern will be over UK Approved Body resource to allow manufacturers to transition in a timely manner, but the MHRA is focusing on growing capacity and implementing new regulatory requirements for Approved Bodies.

With no draft text currently available of the new UK MDR with manufacturers following the UK MDR 2002 or the EU Directive framework, it is unclear what path companies need to take to supply Great Britain. Hopefully, this will change soon.