After many delays it now officially available: the new ISO14155 standard for clinical investigations of medical devices . This third edition of the standard cancels and replaces the second edition from 2011.
What is this standard about?
The International Organization for Standardization (ISO) publishes the ISO standard for Good clinical practices (GCP) for the design, conduct, recording and reporting of clinical studies with medical devices. Conducting your clinical studies according to GCP is important not only to collect good quality data under ethical conditions but also for regulatory compliance in the European Union (EU) and rest of the world.
The EU Medical Devices Regulation (MDR) 2017/745 requires clinical investigations to be conducted according to GCP and directly references the ISO14155 standard. 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. FDA recognizes the ISO14155 standard for medical device trials. Other regions similarly recognize the GCP standard.
Not only pre-market clinical investigations should be conducted according to GCP. 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 responsibilities of sponsor and principal investigator;
- Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
What is new?
The principles of good clinical practice as well as the way clinical trials are designed, conducted and reported remain the same but there are some new elements introduced with this update. The main changes are the reinforcement of risk management in all phases of trial conduct, further alignment with ICH-GCP, and several additions and clarifications as listed below. The change we like the most is the additional text that explains how the standard can be applied to post-market studies of different designs. Below is a summary of changes:
- Inclusion of a summary section of GCP principles (closely aligned with ICH-GCP);
- Reference to registration of the trial in a publicly accessible database (alignment 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]).
Do I have to comply immediately?
A standard is valid from the moment of publication. It is expected that there will be no official transition period communicated for this standard. Since the changes are relatively small, we recommend to implement the updated ISO14155 as soon as possible.
Where do I obtain a copy?
ISO standards are copyright and cannot be distributed freely. You can purchase ISO Standards and other ISO publications from the ISO country members. The ISO members page lists contact information for all ISO members, including links to their online stores where available. Multiple languages are available. Note that the same standard may have a different price in different countries.
Is it enough to comply to the ISO14155 standard?
No, clinical investigations in Europe must comply with the Medical device directives (MDD) and from 26 May 2021 on with the MDR. Clinical investigations must further comply with good clinical practices (for example, ISO14155), relevant provisions of the EU General Data Protection Regulation (GDPR) 2016/679 the Declaration of Helsinki and applicable national laws.
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 comply with the ISO14155 standard in all medical device studies in humans, both pre-market and post-market.