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Draft Secondary Legislation
The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021

Published - Thursday 17th June 2021

Department: Department of Health and Social Care

These Regulations amend the Medical Devices Regulations 2002 (S.I. 2002/618), to require that coronavirus test devices must be approved by the Secretary of State, before they are placed on market or put into service. They specify the application procedure for approval, and the performance requirements that such devices must meet …


Draft Secondary Legislation
The Medical Devices (Northern Ireland Protocol) Regulations 2021

Published - Wednesday 16th June 2021

Department: Department of Health and Social Care

These Regulations make provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC …


Draft Secondary Legislation
The Health Security (EU Exit) Regulations 2021

Published - Tuesday 8th June 2021

Department: Department of Health and Social Care

These Regulations are made in part in exercise of the powers in section 8(1) of the European Union (Withdrawal) Act 2018 (c.16) in order to address failures of retained EU law to operate effectively and other deficiencies (in particular under section 8(2)(a) and (g) of that Act) arising from the …


Draft Secondary Legislation
The Calorie Labelling (Out of Home Sector) (England) Regulations 2021

Published - Thursday 13th May 2021

Department: Department of Health and Social Care

These Regulations require qualifying businesses which sell food for immediate consumption, either in a café, restaurant or other catering establishment or as take away food, to provide information relating to the energy content of the food they sell to consumers in kilocalories (“calorie information”).


Draft Secondary Legislation
The Coronavirus Act 2020 (Early Expiry) Regulations 2021

Published - Wednesday 21st April 2021

Department: Department of Health and Social Care

These Regulations provide for the expiry of twelve sections of the Coronavirus Act 2020 (c. 7) (the “Act”). There are seven devolved sections, sections 8, 9 and 25 to 29, for which the Secretary of State has obtained the necessary consent to expire on behalf of Wales, Scotland, and Northern …


Draft Secondary Legislation
The Food and Feed Safety (Miscellaneous Amendments and Transitional Provisions) Regulations 2021

Published - Monday 22nd March 2021

Department: Department of Health and Social Care

Part 2 of these Regulations is made in exercise of the powers conferred by the Food Safety Act 1990 (c. 16). Part 2 amends the Quick-frozen Foodstuffs (England) Regulations 2007 (S.I. 2007/191) and the Food Additives, Flavourings, Enzymes and Extraction Solvents (England) Regulations 2013 (S.I. 2013/2210). The amendments to these …


Draft Secondary Legislation
The Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) (No. 2) Regulations 2020

Published - Monday 30th November 2020

Department: Department of Health and Social Care

These Regulations make modifications to the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (“2014 Regulations”) which are needed as a result of the effects of the coronavirus pandemic.


Draft Secondary Legislation
The Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020

Published - Wednesday 25th November 2020

Department: Department of Health and Social Care

These Regulations provide for certain tests for coronavirus to meet specified standards. Regulation 3 specifies the tests to which these Regulations apply. Regulations 4 and 5 set out standards to be met by tests and test providers, respectively. Regulation 6 requires test providers to apply for accreditation with the United …


Draft Secondary Legislation
The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020

Published - Tuesday 10th November 2020

Department: Department of Health and Social Care

These Regulations are made in exercise of the powers in sections 8(1) and 8C of the European Union (Withdrawal) Act 2018 (c. 16) in order to address failures of retained EU law to operate effectively and other deficiencies (in particular under section 8(2)(a)) arising from the withdrawal of the United …


Draft Secondary Legislation
The Coronavirus Act 2020 (Expiry of Mental Health Provisions) (England and Wales) Regulations 2020

Published - Wednesday 21st October 2020

Department: Department of Health and Social Care

These Regulations expire parts of Schedule 8 to the Coronavirus Act 2020 (c. 7) (the “Act”) in both England and Wales. Schedule 8 to the Act made certain modifications to the Mental Health Act 1983 (c. 20) in response to coronavirus. It has not been commenced in relation to England, …