MHRA publishes updated designated standards list for devices

Following feedback to MHRA’s call for evidence survey on designated standards, the agency has published the first set of updates to the designated standards lists for general medical devices, in vitro diagnostic (IVD) devices and active implantable medical devices.

The updates include revised designations for key standards relating to risk management of medical devices and quality management systems, and are the first in a series of planned updates in 2026.

MHRA is also developing a new internal process to ensure the designated standards lists remain responsive to emerging and updated standards, as medical technologies continue to evolve.

Compliance with appropriate standards is thought of as a way for an organization to demonstrate that their devices meet certain requirements. It may be helpful to consider that manufacturers are required to apply standards relative to their particular device.

For example, EN ISO 13485:2016 states that it is not the intent of that International Standard to imply the need for uniformity in the structure of different quality management systems, uniformity of documentation or alignment of documentation to the clause structure of the standard.

The standard also makes clear that the adoption of a quality management system is a strategic decision of an organization and that the design and implementation of an organization’s quality management system is influenced by a variety of factors including the organization’s particular objectives, its varying needs, the product provided and the processes employed, and the regulatory requirements applicable to the organization’s activities.

If your organization finds compliance with standards in relation to your specific requirements challenging, talk to Rosa.