Brexit: Leaving the European Union (EU) put the UK into a transitional phase, designed to soften the impact on businesses and allow the UK and EU to conclude a future trading relationship. The transition period for the exit of the UK from the EU ended on 31 December 2020. From 1 January 2021, the medical device regulatory landscape in the UK changed. The regulatory structure for medical devices is very complicated and fragmented.
Listed below are the old and new medical device regulations in EU and the UK, as identified by GlobalData.
The EU medical device regulations
Since the early 1990s, medical devices in the EU have been regulated by three EU directives: active implantable medical devices directive (EU AIMDD), in vitro diagnostic devices directive (EU IVDD), and medical devices directive (EU MDD).
This legislation was implemented and enforced in each EU member state by a competent authority. In the process, medical devices were assessed for conformity with EU standards by third-party organisations known as ‘Notified Bodies’ designated by the competent authorities in each country. Products that conformed to the standards could then display the Conformité Européen (CE) mark and access the EU market with that certification.
In May 2017, the EU had a major update to its regulatory framework to keep up with advances in science and technology. As such, two new regulations, Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR), came into effect with a staggered transitional period.
The MDR was due 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 five-year transition period.
The UK medical device regulations
The MDR was intended to also pass into British law at the same time, ensuring a smooth passage for medical devices. However, due to the delay, the new regulation came into effect outside of the Brexit transition period and was therefore not implemented into UK law.
The UK regulatory framework for medical devices known as the Medical Devices Regulations 2002 (MDR 2002), which originates from the EU directives, has been preserved and converted into UK domestic law. This law in its amended format will stay in place until 30 June 2023.
On 11 February 2021, the Medicines and Medical Devices Act was passed into law enabling the UK to build its own regulatory system. This section highlights the new regulations for existing and new medical devices.
Existing medical devices
From 1 January 2021, manufacturers with devices already on the UK market were required to undertake certain regulatory activities to maintain conformance. 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 registration process depending on the risk of the device, where higher-risk devices required an earlier registration. Manufacturers based outside the UK were required to appoint a ‘UK Responsible Person’ to register devices with the MHRA in line with the grace periods.
This is an edited extract from the Brexit Impact on Medical Devices – Thematic Research report produced by GlobalData Thematic Research.