Overview of the Act
The Medicines and Medical Devices Act 2021 (the Act):
establishes a Patient Safety Commissioner, with the core duties of promoting patient safety and the importance of the patient voice in relation to the regulation of human medicines and medical devices;
introduces targeted delegated powers in the fields of human medicines, veterinary medicines and medical devices to enable the existing regulatory frameworks to be updated following the United Kingdom’s (UK) departure from the European Union (EU);
provides information sharing gateways to enabling sharing of information with relevant persons (such as regulators and regulatory networks) outside of the UK in order to give effect to international agreements and arrangements concerning the regulation of human medicines, veterinary medicines and medical devices;
provides a delegated power to establish one or more information systems in relation to medical devices;
provides a delegated power to establish on a legislative basis a medical device expert advisory committee; and
consolidates the enforcement provisions for medical devices and introduces civil sanctions.