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Clinical evidence guidelines: Medical devices

6 November 2020
Download Clinical evidence guidelines: Medical devices

Description

The Clinical Evidence Guidelines for medical devices are intended to provide guidance to manufacturers of medical devices (including In vitro diagnostic medical devices (IVDs)) on what constitutes clinical evidence and the process of clinical data generation and clinical evaluation to produce such clinical evidence. While this guideline refers to IVDs, it is acknowledged that the information provided at this point is incomplete.

Sections of this guidance provide specific information on the clinical evidence requirements for the following types of devices:

  • Total and partial joint prostheses
  • Cardiovascular devices to promote patency or functional flow
  • Implantable pulse generators
  • Heart valve prostheses
  • Supportive devices - meshes, patches and tissue adhesives

There is also a specific section (Section 10) on implantable medical devices in the magnetic resonance environment.

  • Introduction
  • Legislative basis
  • Part 1 - General requirements
    1. The essential principles
    2. Clinical evidence
    3. Clinical evaluation report and supporting documents
    4. Demonstrating substantial equivalence
  • Part 2 - Requirements for specific high risk devices
    1. Total and partial joint prostheses
    2. Cardiovascular devices to promote patency or functional flow
    3. Implantable pulse generator systems
    4. Heart valve replacement using a prosthetic valve
    5. Supportive devices - meshes, patches and tissue adhesives
    6. Implantable devices in the magnetic resonance environment
  • Appendix 1: CER and supporting documents
  • Appendix 2: Glossary and abbreviations
  • Appendix 3: Source material
  • Appendix 4: References

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