Are the EU Harmonised Standards valid also in the UK?

As of January 1, 2021, the UK has continued to maintain many of the EU requirements, including the use of harmonised standards that can be used as a presumption of conformity for the legal requirements they cover. These EU harmonised standards were renamed and became designated standards in the UK. They apply to Northern Ireland, where EU legislation still applies, even though the UK government is still looking for new ways to regulate the situation on the NI market.

Designated standards are commonly used by companies to provide evidence of compliance with essential requirements. Those standards may relate to products, services or processes of companies, but it is important to keep in mind that they do not replace mandatory essential legal requirements – they are merely a tool to comply with them.

How are designated standards adopted?

Designated standards are developed by consensus and must be published as a reference on GOV.UK in a formal notice of publication.  The UK government will make public its proposals on the site for 28 days, and approved references to the standards will be published on the 29th day, unless the proposal is withdrawn or amended before that date.

At the moment, there are four recognised standardisation bodies:

  • British Standards Institution (BSI);
  • European Committee for Standardisation (CEN);
  • European Committee for Electrotechnical Standardisation (CENELEC);
  • European Telecommunications Standards Institute (ETSI).

Moreover, standards can be recognized by international standardising bodies, for instance: the International Organization for Standardization (ISO), International Electrotechnical Commission (IEC), and International Telecommunication Union (ITU).

How to understand the references to Designated Standards

 Based on the prefix of the designated standard, it is possible to understand the recognised standardization bodies or the international standardizing body that adopt it.

Among the prefix, designated standards can be indicated by “BS”, “EN”, “EN ISO” or “EN IEC”. However, the prefix EN indicates a standard that had been adopted by a European standardizing body.

For the time being, the essential legal requirements in GB remain equivalent to the EU law, but should the GB legal requirement change, then the standards would also need to be revised.

Should you like to know more about Designated Standards or appoint Obelis UK as your UK RP, please do not hesitate to contact us.

Are you a COVID-19 test manufacturer placing your devices on the UK market? Contact us now and we will assist you in your path to compliance!

Carla Pintor

Regulatory Affairs Department

04.11.2021

Should you like to appoint Obelis UK as your UK RP, or if you simply need guidance on your UK documentation, please do not hesitate to contact us.

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References:

European Commission. Internal Market, Industry, Entrepreneurship and SMEs. Harmonized Standards. Retrieved on 03/11/2021 from https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en

GOV. UK. (2021). Guidance Designated standards. Retrieved on 03/11/2021 from https://www.gov.uk/guidance/designated-standards

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