UK designated standards

It is important to be aware that the MDR and IVDR will not be implemented in England, Scotland and Wales.
In this context, the distinction between Great Britain (GB) – England, Scotland and Wales – and the United
Kingdom, which comprises Great Britain and Northern Ireland, is relevant. Northern Ireland will have a special status as EU rules will continue to apply there. The Northern Ireland Protocol is a key part of the agreement on the UK withdrawal from the European Union. The effect of the Northern Ireland Protocol is that products on the Northern Ireland market, including medical devices, are required to comply with EU Regulations and Directives as well as with UK law. Separate requirements regarding CE marking will apply in Northern Ireland.

The UK Medical Devices Regulations19 implement the EU Directives for active implantable medical devices,[20] medical devices[21] and in vitro diagnostic medical devices[22] (IVDs) in the UK and continue to apply in Great Britain. These Directives have specific roles for harmonized standards in demonstrating conformity (see 3.2).

Therefore, the UK Medical Devices Regulations have a similar role for standards to support the regulatory
requirements. With the UK leaving the EU, the link with the publication of the list of harmonized standards published in the Official Journal has been broken. As a result, the UK has published its own list of standards that support UK Regulation. These have been termed ‘designated standards’

Three lists of designated standards for medical devices have been published. These lists of standards apply to medical devices,[23] active implantable medical devices[24] and in vitro diagnostic medical devices,[25] respectively.

At the time of publication, the lists of UK designated standards reproduce the harmonized standards in the Official Journal of the European Union for the respective Directives for medical devices. The listed standards are all European standards and not identified as the UK adoptions of those standards by BSI. Harmonize European standards include a European foreword and Annex Zs that describe the relationship between the requirements of the standard and the regulatory requirements in the Directives that are applicable to the scope of that standard. As the UK Regulations currently mirror the requirements in the EU Directives for medical devices, the Annex Zs currently also link the requirements of the standard with the requirements of the UK Regulations.

The process by which the lists of designated standards will be maintained has not yet been made available publicly. As no further standards will be harmonized in Europe for the Directives for medical devices, future European Standards will not be published with Annex Zs for these Directives. In addition, the UK Regulations will be updated and the Medicines and Medical Devices Act [26] has been adopted. If the regulatory requirements in Great Britain start to diverge from those in the EU, the relationship between the UK Regulations and a particular standard might not be reflected by a European Annex Z. Therefore, adoptions of European standards in the UK might also contain a national annex that is the equivalent of a European Annex Z showing the relationship between the standard and the regulatory requirements in Great Britain. The European Annex Zs, with the relationship between the standard and the MDR or IVDR, will be relevant for Northern Ireland.

This blog post is an excerpt from our latest whitepaper: Using Standards to Demonstrate Conformity. Please download the full whitepaper to find out more information. 

[19] The Medical Devices Regulations 2002 (SI 2002 No 618, as amended).
[20] Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices.
[21] Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.
[22] Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.
[23] Notices of publication and a consolidated list for designated standards for medical devices.
[24] Notices of publication and a consolidated list for designated standards for active implantable medical devices.
[25] Notices of publication and a consolidated list for designated standards for in vitro diagnostic medical devices.
[26] Medicines and Medical Devices Act 2021.