Brexit: Leaving the European Union (EU) has placed the UK in a transition phase, designed to mitigate the impact on business and allow the UK and EU to enter into a future trading relationship . The transition period for the UK’s exit from the EU ended on 31 December 2020. From 1 January 2021, the regulatory landscape for medical devices in the UK has changed. The regulatory structure for medical devices is very complicated and fragmented.
Below are the old and new medical device regulations in the EU and UK, as identified by GlobalData.
European regulations on medical devices
Since the early 1990s, medical devices in the EU have been regulated by three European directives: the Active Implantable Medical Devices Directive (EU AIMDD), the In Vitro Diagnostic Devices Directive (EU IVDD) and the on medical devices (EU MDD).
This legislation has been implemented and enforced in each EU Member State by a competent authority. During this process, the compliance of medical devices with EU standards was assessed by third-party organizations called “Notified Bodies” appointed by the competent authorities in each country. Products complying with the standards could then display the European Conformity (CE) mark and enter the EU market with this certification.
In May 2017, the EU made a major update to its regulatory framework to keep up with advances in science and technology. Thus, two new regulations, the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR), entered into force with a staggered transition period.
The MDR was to become fully applicable in May 2020 after a three-year transition period but was postponed to May 2021 due to the Covid-19 pandemic. The IVDR will be fully applicable in May 2022, after a transition period of five years.
UK medical device regulations
The MDR was also to pass into UK law at the same time, ensuring a smooth passage for medical devices. However, due to the delay, the new regulation entered into force outside the Brexit transition period and was therefore not transposed into UK law.
The UK regulatory framework for medical devices known as the Medical Devices Regulations 2002 (MDR 2002), which derives from EU directives, has been preserved and converted into UK national legislation. This law in its amended form will remain in force until June 30, 2023.
On February 11, 2021, the Medicines and Medical Devices Act was enacted allowing the UK to set up its own regulatory system. This section highlights new regulations for existing and new medical devices.
Existing medical devices
From 1 January 2021, manufacturers of devices already in the UK market were required to undertake certain regulatory activities to maintain compliance. As such, the Medicines and Healthcare Products Regulatory Agency (MHRA) became responsible for the UK medical device market.
The new regulations required medical devices of all classes to be registered with the agency. Manufacturers were given a grace period of four to 12 months to comply with the new device risk-based registration process, where high-risk devices required registration earlier. Manufacturers based outside the UK were required to appoint a ‘UK responsible person’ to register the devices with the MHRA under the grace periods.
This is an edited excerpt from Impact of Brexit on Medical Devices – Topic Search report produced by GlobalData Thematic Research.