, many changes have been introduced to how medical and in vitro diagnostic devices are placed on the market in Great Britain. At present, the changes involve secondary legislation. The manufacturers can choose to comply with the MD 93/42/EEC, EU MDR 2017/745, or UK MDR 2002
to place devices on the UK market until July 1, 2023.
To improve how medical and in vitro diagnostic devices are regulated in the UK, the Medical Devices Regulations 2002 will soon be amended. For this reason, between September and November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) consulted on proposed changes to the future medical device regulatory framework, which aims towards:
- improved patient and public safety, greater transparency of regulatory decision-making, and medical device information
- close alignment with international best practices, and
- more flexible, responsive, and proportionate regulation of medical devices.
The consultation involved responses from 413 individuals and 451 organisations. Considering the responders’ answers, the government responded to all the proposals, summarised in the report from June 26, 2022.