The ISO14155 provides an important guide on the use of Good Clinical Practice in clinical investigations. In the ISO14155 you’ll find the main requirements to:
- protect the well-being, safety and rights of human subjects in the clinical investigation;
- assure the scientific relevance of the investigation and the trustworthiness of its results;
- define what the sponsor as well as the investigator are responsible for;
- assist all those parties involved in the conformity assessment of medical devices (sponsors, investigators, ethics committees, authorities and more).
The ISO14155:2020 update is the newest standard for the design, conduct, recording and reporting of clinical investigations for medical devices. In this article, we focus on what has exactly changed in the new ISO14155:2020 standard.
What’s new in the ISO14155:2020 update?
Since July 2020, the ISO14155 has been updated to its third edition. The 2020 version supersedes its precursor from 2011. The main reason that the ISO14155 has been updated, is to ensure that it’s in line with the latest developments in rules and regulation, such as the European Medical Device Regulation (MDR). Where the MDR requires the use of harmonized standards in the industry of clinical investigations.
The new ISO14155 is about 25 pages longer compared to its precursor and has a larger emphasis on the importance and role of clinical evidence, as well as certain risk management principles and a better guidance on how to design the clinical study. The major changes in the 2020 version are mentioned in the list below. Please keep in mind that all of these are very important when you’re planning, designing or conducting a clinical investigation.
- In the new version of the ISO14155, the opportunity is discussed for remote monitoring, digital signaturing for informed consent forms and a validation process for eCRFs systems.
- It is now more evident that all countries need to register clinical investigations in publicly available databases, and update these accordingly.
- It is now more evident that the investigation’s result needs to be published, regardless of the outcome.
- A new concept is introduced in the ISO14155: the serious health threat. This can be seen as a signal indicating the risk of death and requiring immediate action from the sponsor as well as the investigator.
- In all stages of the clinical investigation a risk-based approach has become the norm. That means risk management activities are to be performed throughout all the steps of the investigation.
- A description is provided of the feedback loop with clinical evaluation and risk management activities. For example, using the clinical evaluation to justify the clinical development stage, as well as the clinical investigation design and the updated version of the benefit-risk analysis.
- Clinical quality management, including the CAPA process (Corrective Action Preventive Action), has been reinforced.
- Facilities are now obliged to select investigation sites carefully and thus be representative of the intended use environment.
- It is now the task of the sponsor to recover and analyse a faulty device.
- According to the 2020 update, CROs (Contract Research Organisations) should be qualified suppliers of the sponsor, according to the Quality Management System (QMS).
- In Annex I – a part that is newly added in the 2020 version of the ISO14155 – some clarifications are described on the applicability of the requirements of this standard to certain clinical development stages. It also provides a table for the planning and designing the investigation throughout the lifecycle of the medical device. That also means pre- and post-market clinical trials.
- In case the sponsor is not located in the country where the study is held, the sponsor is obliged to select a local representative.
Important take-aways for medical device manufacturers
Are you a medical device manufacturer and do you want to implement the 2020 update of the ISO14155 in your clinical investigations? We recommend you to start transitioning today!
Her are some tips and tricks to help you:
- Make sure your transition activities are well documented.
- Implement the new ISO14155 standards into your QMS. Make sure you also perform a gap analysis. This will help you find certain shortcomings, like missing risk management procedures on data integrity, safety reportingprocedures using outdated guidelines and missing risk based monitoring
- Train your clinical professionals in the use of and the knowledge about the ISO14155:2020 update. Make sure they know about the most important changes and updates, such as risk management, CAPA, clinical evaluation.
- If you have any templates on clinical investigation processes, please update accordingly.
- If you haven’t validated your eCRF system yet, please do so ASAP.
- Make sure that your CRO has a formal qualification as a supplier. Do not forget to update your contracts with them.
E-learning course: learn everything about the ISO14155:2020 edition
Do you want to learn more about the 2020 update of the ISO14155? In my e-learning training on this subject, I will teach you everything there is to know about the updates provided in the 2020 version of the ISO14155. This training has been taken by >100 clinical investigators and sponsors and has been accredited by a certified accreditation association which guarantees the quality of the training. This training gives you in-depth preparation on the correct use of the ISO14155:2020 throughout the design, conduct, recording and reporting of clinical studies for medical devices.