The third edition of ISO 14155 is currently being prepared for circulation and ballot as ISO/FDIS 14155:2019. Jeremy Tinkler, Director of Regulatory Consultancy at MedPass and Chairman of the ISO Technical Committee responsible for this standard, has written an article for the August edition of the Journal of Medical Device Regulation examining why the revision was necessary and what changes have been made. He notes that, although publication of third edition should not lead to any major changes in the clinical research activities of users who were fully compliant with the second edition, the extensive additional clarification and guidance are expected to be very useful to them. It should also result in a gradual increase in patient safety, as its implementation takes effect.
The article provides a historical perspective by putting the revision of the standard into the context of the development of standards and guidance on Good Clinical Practice (GCP). The standard is now 40% longer than the 2011 version and has 10 annexes instead of seven. Moreover, three of the annexes are now normative (containing requirements), rather than one. The article identifies the reasons for the revision, noting that it addresses the following needs:
- – Alignment with developments in regulations and other standards.
- – Reflection of the continued emphasis on clinical evidence in European Regulations.
- – Closer alignment with definitions in updated GCP guidelines for medicinal products.
- – Guidance on study design.
- – Additional guidance on risk management.
The main changes between the second and third editions of the standard are discussed. These comprise:
- – Inclusion of a summary section of GCP principles.
- – Reference to registration of the clinical investigation in a publicly accessible database.
- – Inclusion of guidance with regard to clinical quality management.
- – Inclusion of risk-based monitoring.
- – Inclusion of guidance on study design and statistical considerations.
- – Inclusion of guidance for Ethics Committees.
- – Reinforcement of risk management throughout the process of a clinical investigation.
- – Clarification of applicability of the requirements of this document to the different clinical development stages.
- – Inclusion of guidance on clinical investigation audits.
- – Applicability to in vitro diagnostic medical devices (IVDs).
- -The need for specific medical expertise in the planning of a clinical investigation.
The article will be published in August. © Journal of Medical Device Regulation