Annex B: employer's legal obligations
Updated 26 February 2021
Applies to England
© Crown copyright 2021
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This publication is available at https://www.gov.uk/government/publications/coronavirus-covid-19-testing-guidance-for-employers/annex-a-employers-legal-obligations
Disclaimer
The legal obligations set out in the guidance have been summarised below.
This guidance, however, does not supersede any legal obligations relating to employment, equalities and data protection, nor does it provide any advice on the steps that might be required in order to meet those, or any other, legal obligations to which you as an employer might be subject when undertaking any activity that falls within the scope of this guidance.
Accordingly, it is important that as a business or an employer you continue to comply with your existing obligations and take independent legal advice if in any doubt about what those obligations are and how they might apply to you.
| Legislation | Obligation |
|---|---|
| Employment, equality and health and safety law | Employers must consider their legal obligations under employment, equality, and heath and safety law. |
|
Data Protection Act 2018 General Data Protection Regulation (GDPR) |
An employer has specific obligations under the GDPR and in particular in respect of handling sensitive health data. These obligations are dependent on the lawful basis relied upon to legitimate processing health data. |
| Control of Substances Hazardous to Health Regulations 2002 Schedule 3: Additional Provisions Relating to Work with Biological Agents | There are specific legal obligations employers and third-party providers must be aware of when overseeing a process involving handling, transportation and laboratory analysis of test samples. |
| Public Health (Control of Disease) Act 1984 and the Health Protection (Notification) Regulations 2010 | When collecting results, all medical practitioners and test providers have a statutory duty to report positive, negative, void and indeterminate results of COVID-19 virus tests to Public Health England. |
| CE mark | All medical devices sold in the UK, manufacturers must place a CE mark on an IVD. Tests without a CE mark are not legally allowed to be placed on the EU and UK markets unless they have an exemption. You can see a list of all tests granted an exemption. Employers are obliged to ensure that the test kit they or their provider is procuring is legal in the UK either through having the CE mark or an exemption. |
| Medical Devices Directive 93/42/EEC | Potential legal obligations in relation to the development of apps or software for the use of capturing, storing and disseminating health results. |
|
Medical Devices Directive 93/42/EEC The In Vitro Diagnostic Medical Devices Directive 98/79/EC |
It is important to note that where a testing service takes on the role of a legal manufacturer of an IVD then the regulations that cover manufacturing become legal obligations. |