The Medicines and Medical Devices Act 2021 (the “MMD Act”) was granted royal assent on 11th February 2021. The MMD Act confers broad powers on the Secretary of State to amend or supplement the law relating to medical devices being placed on the UK market.
Amongst other things, the MMD Act provides a power for the Secretary of State to make provision, under secondary legislation, about the establishment and operation of registers of medical devices that are available on the UK market. These ‘information systems’ could allow the MHRA to respond to concerns around patient safety and assist with making evidence-based decisions about whether to remove products from the market. The functionality of the registers created could also support the MHRA’s post-market monitoring of medical devices by facilitating the tracking and monitoring of medical devices being used across the UK.
The MMD Act also introduces new offences, sanctions and enforcement regimes that could be imposed for breaches of medical devices related laws and regulations, which could vary between imprisonment, a fine, or both.
The introduction of secondary legislation under the MMD Act will be a topic of great interest to manufacturers wishing to place medical devices on the UK market, as the overarching objective of any such legislation must be the safeguarding of public health, with consideration to:
- the safety of medical devices;
- the availability of medical devices; and
- the likelihood of the UK being seen as a favorable place in which to carry out medical devices research, develop medical devices or manufacture or supply medical devices.
As a result of the Sectary of State’s power, the UK legislation regarding medical devices will continue to be updated in line with research and developments in this area. The aim of any such research and developments will likely be to ensure the UK remains a leader in the global life sciences industry and has a robust regime in place to safeguard public health when placing medical devices on the UK market.
See the MMD Act in full here.