UK and Brexit: towards new Regulations for IVD medical devices

In May 2017, the European Union introduced two new Regulations for medical devices, the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). The transition periods in the EU were extended mainly due to COVID-19.

Whilst Brexit happened in 2016, the UK legislation in general terms (not only for medical devices) did not see a real change and clear course of action until 2020

In addition to the pandemic, the realization that the new regulation would take longer to apply in Europe than expected and a general desire to accommodate all parties resulted in further postponements. Thus, the transition periods were extended to May 26, 2021, for MDR, and there was extension of grace period for certain IVDs under the IVDR.

New legislation for the UK

Certainly, the new EU Regulations do not apply in the United Kingdom, while they do apply in Northern Ireland! However, the UK keeps the previous MDD and IVD Directives as the foundation of its regulatory structure. Nevertheless, the UK has already announced that it will implement a new Regulation, following the path previously drawn by the EU.

Will the new UK Regulation be very different from the previous Directive?

For IVDs, there might be some differences between the previous EU Directive and the new Regulation in the United Kingdom. Especially, there will likely be a combination of increased premarket clinical data and post market surveillance. Different sources argue that these measures may take a toll on smaller companies, notified bodies, and ultimately the consumers.

We still do not know when the UK will publish the new UK Regulation on medical devices and IVDs. Nonetheless, what is quite clear is that whatever the changes are, they will not be done overnight, but rather in a calculated and scaled manner.

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Silvia Zarzuela Martín

14/03/2022

RA Department

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References:

Haskell, H. (06/08/202). Cumberlege review exposes stubborn and dangerous flaws in healthcare. BMJ. Retrieved on 21/04/2022 https://doi.org/10.1136/bmj.m3099

Medical Technology. (2022). New UK medical device regulation spells potential trial concerns for some IVD players. Medical Devices. Retrieved on 21/04/2022 from https://medical-technology.nridigital.com/medical_technology_mar22/new_medical_device_regulation

Gov.Uk (2022). Consultation on the future regulation of medical devices in the United Kingdom. Medical Devices Regulation and Safety. Retrieved on 21/04/2022 from https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom

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