ISO 14155 – Medical Devices Clinical Investigations on Human Subjects

The third edition of ISO 14155:2020 – Medical Devices Clinical Investigations on Human Subjects – Good clinical practice) provides references for

  • Designing
  • Conducting
  • Recording
  • Reporting of clinical studies regarding medical devices.

ISO 14155:2020 guides clinical research professionals and medical device manufacturers regarding the implementation of Good Clinical Practice (GCP), which they can apply in pre and post-market clinical investigations. These market investigations are designed to determine the safety and performance of a medical device.

General Specifications and Requirements of ISO 14155

Clinical Investigations in Europe & Compliance

What is New in 3rd Edition of ISO 14155?

The 3rd edition of ISO 14155 introduces many new changes and updates such as:

  • Emphasis on clinical evidence
  • Improved guidance (or study design)
  • Clarification on facilitating compliance with other international standards (e.g., with ICH-GCP)
  • Application of ISO 14971’s risk management principles on all stages of clinical investigations.

2ND Versus 3rd Version of ISO 14155

Note: By adding “clinical risk management” to the list of sponsor abilities, the third version of ISO 14155 has introduced the clinical quality management process. Now, it will require the sponsor’s implementation and oversight even if the task gets outsourced to a third-party Clinical Research Organization (CRO).

Major Changes in 3rd Version of ISO 14155

ISO 14155 & Application of GCP to Various Stages of Clinical Development

Another major update in the third version of ISO 14155 is that it provides clarity regarding the application of GCP to the various stages of clinical development. These stages are:

  • Early feasibility studies
  • Pre-market clinical investigations
  • Post-market studies
  • Registries.

EU MDR 2017/745 requires writing the clinical development section of the Clinical Evaluation Plan (CEP). This new update shall provide feasibility in doing so.

Implementation of ISO 14155:2020

ISO 14155 has been ready for implementation since its publication, i.e., July 2020. Even though the 3rd version of the standard contains many new updates, clarifications, and guidance, it should not significantly change the sponsors and clinical research professionals conducting trials according to ISO 14155:2011. It will also be necessary for both of them to ensure compliance with the 3rd version ISO 14155 while designing MDR clinical strategies and clinical investigations.

Getting ISO 14155

ISO 14155 is available for purchase from any ISO member. Purchasing its PDF and e-Pub layout will facilitate clinical research teams with different valuable tools which they can use to show compliance to the standard.

Where to Use ISO 14155 in Clinical Development?

Application of ISO 14155 on all the stages of clinical development is necessary. Be it

  • Early feasibility studies
  • Pre-market investigations
  • Post-market clinical investigations
  • Post-market studies
  • Registries, ISO 14155 applies to every single stage of clinical development.

Those medical device manufacturers who will comply with ISO 14155 will ensure ethical scientific conduction of clinical investigations.

Benefits of Conducting Clinical Investigation According to ISO 14155

Looking for ISO 14155 Compliant Systems?

Considered pioneers in the medical device manufacturing industry, TSQ and E are providing ISO 14155:2020 compliant systems to medical device manufacturers worldwide. Our consultancy will help you in the proper adoption of ISO 14155 compliant systems, and you will be able to attain international recognition for your clinical investigations. Contact us today through our website tsquality.ch.

About the Author

Waqas Imam

S. M. Waqas Imam is associated with TS Quality as a Regional Partner. He is also an ambassador of Medical Device Community. He is an Industrial Engineer by qualification and served the manufacturing industry since 2011. He is also IRCA CQI Lead Auditor of ISO 9001 and other management system standards. He had served as Quality Assurance and Regulatory Affairs Manager in QSA Surgical Pvt. Ltd. and Ultimate Medical Products. He managed requirements of ISO 13485:2003, EU directives, CE marking and FDA. He also served as Expert Blog Writer for 13485Academy and wrote expert articles on various topics of ISO 13485:2016.