Over the past several years, regulations for the medical device industry have continued to evolve placing more emphasis on clinical data and patient safety.
It started with the transition to the new European Union Medical Device Regulation (EU MDR) which incorporated more scrutiny on clinical evidence. And, more recently, it expanded to include the updated ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good Clinical Practice (GCP).
The third edition of the ISO 14155 guidance outlines standards for the design, conduct, recording and reporting of medical device clinical studies, providing manufacturers with information on how to implement GCP for pre- and post-market clinical investigations to determine safety and performance of a medical device. This standard is valid from July 2020 with no official transition time, and, specifically, outlines requirements intended to:
- Protect the rights, safety and well-being of human subjects
- Ensure the scientific conduct of the clinical investigation and the credibility of 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
New changes to the 2020 revision of ISO 14155
Widely used across the world by manufacturers and regulatory authorities, the updated edition introduces clarifications to facilitate compliance to other international standards. For example, the U.S. Food and Drug Administration (FDA) recognises the ISO 14155 standard for medical device trials and accepts clinical data collected outside the U.S.
To align with recent regulatory changes, updates include (1) a stronger emphasis on the role of clinical evidence, as presented in the EU MDR; (2) the addition of clinical risk management to the manufacturer’s responsibility; and (3) improved guidance on clinical study design. Also, the document provides more information on conducting safer medical device clinical trials with better evidence, detailing informed consent, vulnerable populations, data protection and statistical considerations.
Plan and execute an ISO 14155- and EU MDR-compliant clinical trial
Medical device manufacturers should comply with the updated standard to ensure credibility of clinical trials, including proper patient safety and scientific conduct. Further, it will be important to ensure compliance with the new standard when designing forthcoming MDR clinical trials. In addition, manufacturers will need to consider whether other standards and/or country or regional requirements also apply to medical device(s) under investigation. In the case that differences in requirements exist, the most stringent guidelines should be applied.
Moreover, while this standard does not apply to in vitro diagnostic medical devices, there may be situations, dependent on the device and national or regional requirements, where manufacturers might consider whether specific requirements of this document could be applicable.
Partner with a regulatory expert
Choosing a partner that has extensive regulatory expertise and can assist in conducting clinical trials according to ISO 14155 and EU MDR standards — at any stage of clinical development — allows device developers to perform international medical device clinical trials that generate clinical data with integrity. With extensive regulatory knowledge, a CRO can help to navigate today’s constantly changing regulatory landscape and accelerate regulatory approval.
To learn more about ICON’s Medical Device & Diagnostics Research regulatory expertise contact us.
For further info on how regulations for the medical device industry have continued to evolve placing more emphasis on clinical data and patient safety, please visit https://www.iso.org/.