The MHRA intends to update the regulatory framework by laying legislation concerning:

• Definitions used in the legislation

• Classifications

• Essential requirements

• Technical documentation retention periods

• Equivalence

• Implant cards

• Custom-made devices

• Claims

• Software as a Medical Device

• In vitro diagnostic (IVDs) devices

• International reliance

• Unique Device Identifiers

• Electronic instructions for use

Please refer to the guidance document for a short description of each of these areas.

When completing the questionnaire please refer to the information stated in the 2026 Regulations as outlined below. Please note that, in some cases, information relating to a single topic is distributed across multiple sections of the 2026 Regulations. Where this occurs, we have provided the primary page references only, rather than an exhaustive list of all relevant pages: 

• Definitions used in the legislation (pages 3-5, 13, 26 and 35-36)

• Classifications (general medical devices and active implantable medical devices: pages 91-100, IVD devices: pages 100-104)

• Essential requirements (general medical devices and active implantable medical devices: pages 71-74, IVD devices: pages 76-77)

• Technical documentation retention periods (pages 16-17, 29-30, 39-40, 74-75, and 78)

• Equivalence (pages 18-19, and 31-32)

• Implant cards (pages 24-25, and 34-35)

• Custom-made devices (pages 13, 14, 21-22, 26, 28, 32-33)

• Claims (pages 24, 33-34, and 44-45)

• Software as a Medical Device (pages 13, 19-20, 22-23, 25-26, 36, 41-43, and 45)

• IVD devices (please see above references, and also pages 35-45)

• International reliance (pages 51-62)

• Unique Device Identifiers (pages 79-87)

• Electronic instructions for use (pages 87 -91)