UK regulatory framework – where are we now?

Laura Friedle-Hurst, Principal Advisor and Managing Director of LFH Regulatory, analyzes the latest news and speculation on the UK regulatory framework.

It seems like a lifetime ago since the referendum on Britain’s membership of the European Union (EU) in June 2016, when Britain exited the bloc in January 2020.

The UK MDR 2002 (SI 2002 No. 618, as amended) has been an integral requirement within the UK. UK regulation closely aligns with and currently follows EU directives:

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These directives have been replaced by the In Vitro Diagnostic Medical Devices Regulation (IVDR), EU 2017/746 with the IVDD and the Medical Devices Regulation (MDR), EU 2017/745 superseding both the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

After the transition period, EU MDR2017/745, and EU IVDR 2017/746 have not been transposed into British law. Since Brexit, Northern Ireland and Great Britain have diverged in terms of their regulatory requirements. Northern Ireland has implemented and continues to follow EU law, while Great Britain currently complies with EU MDD/IVDD/AIMDD (where applicable), or MDR/IVDR and/or UK MDR , the purpose of which is to create new laws currently being prepared.

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 a consultation on “The future regulation of medical devices in the UK”, indicating future changes to UK medical devices regulation Is. Five pillars on which the UK MDR would be based were established:

• Strengthening MHRA power to act
• Making the UK a focus for innovation
• Addressing health disparities and reducing biases throughout the medical device product lifecycle
• Proportionate regulation that supports businesses through access routes that build on synergy with both EU and wider global standards
• To create the UKCA mark as a global example.

Initially, the UK MDR was due to come into force in July 2023, but the MHRA extended the deadline by 12 months. A draft text is expected by mid-2023 followed by a two-month consultation.

Transitional arrangements are needed for the UK MDR to facilitate the supply of equipment to Great Britain as part of transition measures but this is still subject to parliamentary approval. Devices can be placed on the Great Britain market under the following timeframes:

• Conforming general medical devices with a valid declaration and CE marking with MDD or AIMDD can be placed on the market in Great Britain until the expiry of the certificate or 30 June 2028.
• In vitro diagnostic medical devices (IVDs) conforming to the IVDD may be placed on the market in Great Britain before the expiry of the certificate or until 30 June 2030 and,
• General medical devices, including custom-made devices that conform to the EU MDR and IVDs that conform to the IVDR, can be placed on the market in Great Britain until 30 June 2030.

Class I medical devices and general IVDs under the EU MDD or IVDD, which did not require a notified body to carry out conformity assessment, can only be placed on the market in Great Britain if the participation of a notified body under the EU MDR or IVDR is carried out. will be required. ,

The government intends to introduce legislation to strengthen post-market surveillance requirements ahead of the framework’s implementation later this year. Currently, the emphasis is on more stringent requirements, stricter timelines, information to be covered for PMS systems including trend reports, FSCA and new requirements for custom built equipment – ​​expected to come into effect from mid-2024.

Manufacturers may have had time to work towards 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, all of which differ under their certification capabilities. Notified bodies cannot certify under the new requirements as these do not yet exist, but many do not yet charge a UKCA certification fee compared to the EU. It is not clear whether existing EU Notified Bodies will expand their current certification capabilities or whether they are stuck to the draft text.

With the current struggle for certification of devices by Notified Bodies in the EU under EU MDR and IVDR, there will be concerns over UK Approved Body resources to allow manufacturers to transition in a timely manner, but the MHRA will focus on increasing capacity and implementation. Focusing on new regulatory requirements for approved bodies.

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

The LFH regulator will be on display at the Med-Tech Innovation Expo on Stand A31. Visit www.med-techexpo.com to register for free. Laura Friedle-Hurst will be part of a live episode of The MedTalk podcast discussing the latest in the UK regulatory landscape on the first day of the Introducing Health-Tech stage.