Setting up V&V for an AIMD

The objective of Verification and Validation activities (V&V) is to collect data to demonstrate conformity of the AIMD with the requirements of the applicable regulation. As the transition from 90/385/EEC Directive (AIMDD) to 2017/745 EU Regulation (MDR) is taking place, the V&V is designed in order to demonstrate conformity with the applicable General Safety and Performance Requirements (GSPRs, as defined in Annex I of the MDR).
The V&V encompass the whole development of an AIMD, from the initial phase when the V&V Plan is outlined, to the finalization of the Technical Documentation for CE marking, when the V&V Report is documented. During the initial phases, Product Requirements are identified (from user needs, GSPRs, risk mitigations, and applicable standards) and translated into Product Specifications. As part of the V&V, Verification Tests include bench testing and, when required, animal testing, whereas Validation Tests include usability and clinical evaluation/investigation(s), to demonstrate compliance to Product Specifications and Requirements, respectively.
As part of the V&V of AIMDs, the key applicable harmonized standards are identified, which include:

  • EN 45502-1, for general requirements;
  • EN ISO 10993-1 for biological safety (biocompatibility) requirements
  • EN 60601-1, for general requirements applicable to the external components of the AIMD
  • Sterilization standards such as EN ISO 11135-1 for Ethylene Oxide sterilization requirements
  • EN 62304, for software development requirements.

For long-established AIMD, additional specific requirements come from subparts of both EN 45502 (such as EN 45502-2-1 for cardiac pacemakers and EN 45502-2-2 for implantable defibrillators) and of ISO 14708 (such as ISO 14708-3 for implantable neurostimulators).

In this context, Medidee can provide support throughout all V&V:

  • Identifying the relevant applicable requirements
  • Building a tailored V&V plan, which takes into account the novelties and criticalities of innovative AIMDs
  • Providing a comprehensive approach to standards applicability, including the prompt application of the state of the art
  • Ensuring traceability between requirements, specifications and V&V tests
  • Ultimately, by reviewing all V&V activities for compliance with the GSPRs