UK lists of designated standards for medical devices published

Standards recognised in support of UK regulations for medical devices identified

Following the end of the Brexit transition period, the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) will not be implemented in England, Scotland and Wales. The UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) continue to have effect. The UK Conformity Assessment (UKCA) mark will apply to medical devices, including in vitro diagnostic medical devices. Northern Ireland will have a special status as EU rules will continue to apply there.

The UK Medical Devices Regulations implement the EU Directives for active implantable medical devices, medical devices and in vitro diagnostic medical devices (IVDs) in the UK. These Directives have specific roles for harmonized European standards in demonstrating conformity. Harmonized standards are those referenced in the Official Journal of the European Union. Devices in conformity with relevant harmonised standards, or applicable parts of standards, are presumed to be in conformity with the regulatory requirements covered by those standards. Additionally, the presumption of conformity has  also been accepted for system or process requirements, including those requirements relating to quality management systems and risk management.

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 harmonised 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;
• Active implantable medical devices;
• In vitro diagnostic Medical devices.

At the time of publication, the lists of UK designated standards reproduces the lists of 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. Harmonised 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.  The UK Regulations will be updated through the Medicines and Medical Devices Bill, which is currently working its way through the legislative process. If the regulatory requirements in the UK 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. It remains to be seen whether UK-specific Annexes will be expected to show the relationship between the requirements of the standard and UK Regulations.

Manufacturers using standards to support the conformity of their devices should be aware of the publication of the UK lists of designated standards and look out for further information on how these lists will be maintained going forward.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development