Guidance on Electronic Instructions for Use of Medical Devices in the UK

1. Introduction

Regulation 4J of the Medical Device Regulations 2002 (as amended) (UK MDR 2002) allows manufacturers of certain types of medical devices and accessories to provide electronic instructions for use. This fulfils the requirements of the medical device regulatory system. Providing instructions for use in electronic form can benefit professional users by reducing environmental burden and costs while maintaining safety. Electronic instructions may also improve safety levels as they are less susceptible to loss, provided sufficient safeguards are in place. https://www.gov.uk/government/publications/electronic-instructions-for-use-of-medical-devices-guidance-on-regulations/guidance-on-the-regulations-for-electronic-instructions-for-use-of-medical-devices

2. Definitions

• Instructions for use: Information provided by the manufacturer to inform the user of the device's safe and proper use, intended performance, and precautions, as outlined in point 15 (Part III of Annex I to the UK MDR 2002, modified by Part 1 of Schedule 2A) and point 13 of Annex I (Part II of the UK MDR 2002, modified by Part 2 of Schedule 2A). https://www.gov.uk/government/publications/electronic-instructions-for-use-of-medical-devices-guidance-on-regulations/guidance-on-the-regulations-for-electronic-instructions-for-use-of-medical-devices
• Instructions for use in electronic form: Instructions displayed electronically by the device, contained in portable electronic storage media supplied with the device, or available through a website. https://www.gov.uk/government/publications/electronic-instructions-for-use-of-medical-devices-guidance-on-regulations/guidance-on-the-regulations-for-electronic-instructions-for-use-of-medical-devices
• Professional users: Persons using the medical device in the course of their work and within a professional healthcare activity. https://www.gov.uk/government/publications/electronic-instructions-for-use-of-medical-devices-guidance-on-regulations/guidance-on-the-regulations-for-electronic-instructions-for-use-of-medical-devices
• Fixed installed medical devices: Devices and accessories intended to be installed, fastened, or secured at a special location in a healthcare facility, immovable without tools or apparatus, and not intended for use in a mobile healthcare facility. https://www.gov.uk/government/publications/electronic-instructions-for-use-of-medical-devices-guidance-on-regulations/guidance-on-the-regulations-for-electronic-instructions-for-use-of-medical-devices

3. Applicable Types of Device

The regulation applies to:

• Active implantable medical devices and accessories intended for exclusive use for an indicated purpose.
• Implantable medical devices and accessories intended for exclusive use for that purpose.
• Fixed installed medical devices.
• Medical devices and accessories (general or active implantable) fitted with a built-in system visually displaying the instructions for use.
• Standalone software covered by the UK MDR 2002. It does not apply to in vitro diagnostic devices (guidance available in MEDDEV 2.14/3 rev.1). https://www.gov.uk/government/publications/electronic-instructions-for-use-of-medical-devices-guidance-on-regulations/guidance-on-the-regulations-for-electronic-instructions-for-use-of-medical-devices

4. Conditions

Manufacturers may provide electronic instructions for use if:

• Intended exclusively for professional users, with non-professional use not reasonably foreseeable.
• A risk assessment concludes that safety levels are maintained or improved compared to paper form.
• Parts of instructions intended for patients are available in paper form.
• Text (which may include symbols and graphics) is identical to paper form; video and audio files may be additional and optional. https://www.gov.uk/government/publications/electronic-instructions-for-use-of-medical-devices-guidance-on-regulations/guidance-on-the-regulations-for-electronic-instructions-for-use-of-medical-devices

5. Risk Assessment

The risk assessment must cover:

• Knowledge and experience of intended users.
• Characteristics of the use environment.
• Expected knowledge, experience, and familiarity of users with hardware and software for displaying instructions.
• Access to reasonably foreseen electronic resources.
• Safeguards against content tampering.
• Safety and backup mechanisms for hardware or software faults, especially if integrated in the device.
• Foreseeable medical emergency situations requiring paper format.
• Impact of temporary website or internet unavailability and coping measures.
• Time period for providing paper instructions on request.
• Measures ensuring electronic instructions reach professional users. The assessment must be updated based on post-marketing experience. https://www.gov.uk/government/publications/electronic-instructions-for-use-of-medical-devices-guidance-on-regulations/guidance-on-the-regulations-for-electronic-instructions-for-use-of-medical-devices

6. Requirements for Electronic Labelling

Where instructions are provided electronically:

• Comply with national regulations on labelling language unless justified in the risk assessment.
• Provide printed paper instructions at no cost within 7 days of request (may request receipt as proof).
• Provide information on the device surface (or leaflet if not practical) about foreseeable medical emergency situations.
• For devices with built-in visual display, include details on how to start the device.
• Ensure proper design and functioning, with verification and validation evidence.
• Ensure failure of built-in display does not impede device functioning or safe use, particularly life monitoring or support functions.
• Provide software and hardware requirements for displaying instructions in product catalogues and support material.
• Have a system to indicate revisions and inform users if revisions are safety-related.
• Keep electronic instructions available for 2 years after expiry of the last produced device (15 years for implantable devices); use independently supported technology with backups.
• Indicate on the unit, sales packaging, or device (for fixed installed) that instructions are electronic and how to access them. Access information must include:
• Information needed to view instructions.
• Unique reference number for direct access and identification.
• Relevant manufacturer contact details.
• Where, how, and by what time to request paper form. https://www.gov.uk/government/publications/electronic-instructions-for-use-of-medical-devices-guidance-on-regulations/guidance-on-the-regulations-for-electronic-instructions-for-use-of-medical-devices

7. Website Provision

Where instructions are provided electronically via website:

• Use a commonly used format readable with freely available software.
• Protect against hardware and software intrusion.
• Minimize server downtime and display errors.
• Mention provided languages.
• Fulfil UK MDR 2002 requirements.
• Display a stable, directly accessible internet address with any code safeguards.
• Include all previous versions with publication dates, clarifying current revisions and product associations. https://www.gov.uk/government/publications/electronic-instructions-for-use-of-medical-devices-guidance-on-regulations/guidance-on-the-regulations-for-electronic-instructions-for-use-of-medical-devices