Sources of information

The UK Responsible Person must understand the legal and regulatory requirements that manufacturers of medical devices must comply with. Following are the key regulatory texts and guidance to be considered.

• The Medical Devices Regulations 2002 (SI 2002 No 618, as amended) 
  • https://www.legislation.gov.uk/uksi/2002/618/contents

• The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (SI 791)
  • https://www.legislation.gov.uk/uksi/2019/791/contents/made

• The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (SI 1478) 
  • https://www.legislation.gov.uk/uksi/2020/1478/made 

• Regulating medical devices from 1 January 2021
  • https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021

• Register as a manufacturer to sell medical devices from 1 January 2021
  • https://www.gov.uk/guidance/register-as-a-manufacturer-to-sell-medical-devices-from-1-january-2021 

• Using the UKCA mark from 1 January 2021
  • https://www.gov.uk/guidance/using-the-ukca-mark-from-1-january-2021