The ISO standard for clinical investigation with medical devices (ISO14155:2011) has been under revision for quite some time. Last week, the new draft standard moved to the approval stage. It is expected that the final draft in standard (FDIS) will be approved and that the new standard will be published this year.
Conducting your clinical studies according to Good Clinical Practice (GCP) is important not only to collect good quality data under ethical conditions but also for regulatory compliance in the European Union (EU) and US. The US Food and Drug Administration (FDA) accepts clinical data collected outside the US for market applications under the condition that GCP has been followed and FDA recognizes the ISO14155 standard for medical device trials (but consider the additional local requirements too).
Not only pre-market clinical investigations should be conducted according to the GCP standard. Also, post-market clinical investigations with medical devices should follow the standard as far as relevant, considering the nature of the clinical investigation and the requirements of national regulations.
The ISO 14155 standard specifies general requirements to:
- Protect the rights, safety, and well-being of human subjects;
- Ensure scientific conduct of the clinical investigation and credibility of the clinical investigation results;
- Define the responsibilities of the sponsor and principal investigator;
- Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
The principles of good clinical practice, as well as the way clinical trials are designed, conducted and reported, are not changed by the revision of the standard. The main changes are a reinforcement of risk management in all phases of trial conduct, further alignment with ICH-GCP, and several additions and clarifications:
- Inclusion of a summary section of GCP principles (closely aligned with ICH-GCP);
- Reference to the registration of the trial in a publicly accessible database (for example clinicaltrials.gov - aligning with the Declaration of Helsinki);
- Risk-based monitoring and considerations when drawing up the monitoring plan;
- Guidance on statistical considerations (in line with increasing requirements by notified bodies! - you will find most changes in the annex that described the contents of the Clinical Investigation Plan);
- Guidance for Ethics Committees (a whole new annex);
- Guidance on audits;
- Guidance and clarifications on clinical quality management;
- Clarification on applicability of GCP to different clinical development stages (we believe this may be a good starting point when writing the Clinical Development Plan section of the Clinical Evaluation Plan [CEP] as prescribed by the Medical Device Regulation [MDR]).
The European Medical Device Regulation (MDR, EU 2017/745) increases clinical data requirements in support of safety and performance of medical devices and is likely to spark an increase in clinical investigations in Europe. In any stage of clinical development, from early feasibility studies to registries, GCP can and should be adhered to in order to ensure ethical and scientific conduct of the investigation and credibility of the results. We recommend to keep a close eye on this standard and make sure you are up to date when you are designing your clinical strategy and setting up new clinical investigations.