Following the UK’s exit from the EU, the regulatory landscape for medical devices remains uncertain. Andrew Thompson, PhD, director of therapy research & analysis at GlobalData, explains what companies need to know.
Need to know:
- Covid-19 caused the implementation of the new EU Medical Device Regulation (MDR) to be delayed by 12 months to May 2021.
- In the UK, new devices must conform to the UK MDR 2002, the EU MDR (until 2023), or the EU In Vitro Diagnostic Regulation (IVDR) (until 2023) in order to be registered with the MHRA. However, while IVDR is due to be implemented for new devices in the EU from May 2023, it is likely to be delayed due to a shortage of notified bodies. Therefore, it’s uncertain whether new in vitro diagnostic (IVD) devices entering the UK will ever be subject to IVDR for UK marketing. Currently, the legal requirements for the UK are based on the IVD Directive. Manufacturers can already use the IVDR to obtain approval.
- Existing devices will remain on the EU market until their CE certificates expire. Then they will need to recertify using the new regulations or take the device off the market. Certificates are generally issued for three years, but for some high-risk devices, this is as short as one year. CE marks will be recognised in the UK until January 2023, at which point manufacturers are expected to comply with the new UKCA compliance marking.
- The UK will introduce a new medical device regulation, based on the findings of the Cumberlege Review, which looked at the harmful effects of some medicines and medical devices on female health.
- If the UK fully takes up recommendations in the Cumberlege Review and adopts the minimal standards of the MDR and IVDR, the UK’s medical device regulatory landscape could end up more stringent than the EU’s.
The year 2020 proved to be a momentous year for medical devices regulation in the UK. In May, there was widespread anticipation around the implementation of the new European Medical Devices Regulation (MDR), replacing the old Medical Devices Directive (MDD). During July 2020, member of parliament Baroness Cumberlege concluded the Independent Medicines and Medical Devices Safety Review, AKA the Cumberlege Review, which looked at the harmful effects of some medicines and medical devices on female health.
On 31 January 2020, the UK formally left the EU, entering a transition or implementation period, designed to soften the impact on business and give the UK and EU the space to conclude future trading relationship arrangements. Around the same time, there was the emergence of a new respiratory disease in China that was to greatly impact the rest of the world.
In 2020, the existing European directives relating to non-IVD medical devices were intended to be replaced by the MDR. This change, planned for May that year, was intended to also pass into British law at the same time – ensuring a smooth passage for medical devices.