Module 19 2021

02/06/2021

Why regulate medical devices? “Regulation is primarily concerned with enabling patient access to high quality, safe and effective medical devices, and avoiding access to products that are unsafe. When appropriately implemented, regulation ensures public health benefit and the safety of patients, health care workers and the community.”

https://www.who.int/medical_devices/safety/en/

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UK Medicines and Medical Devices Act 2021

…the Secretary of State must have regard to— (a) the safety of medical devices; (b) the availability of medical devices; (c) the likelihood of the United Kingdom being seen as a favourable place in which to— (i) carry out research relating to medical devices, (ii) develop medical devices, or (iii) manufacture or supply medical devices.

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