Updated Standards for Conducting Medical Device Clinical Trials
In 2011, the International Organisation for Standardisation (ISO) adopted and published a revised version of ISO14155, essentially a clinical practice roadmap for taking a medical device through the clinical trial life cycle.
This amendment to the 2003 standard, known as ISO 14155:2011, provides guidance for conducting medical device clinical investigations, in which sponsors are responsible for implementing a risk management program, classification of adverse events and monitoring the ongoing safety evaluation of the clinical investigation for their medical devices.
Charting the changes
Perhaps the most obvious change is the title of the standard itself: ISO 14155:2011 Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice (GCP). The addition of GCP to the title indicates the alignment of medical device investigations to the International Conference on Harmonisation Good Clinical Practices (ICH GCP) E6 guidelines. Previously, ICH GCP and ISO14155 appeared contradictory, posing challenges for medical device manufacturers since their products typically feature physical, mechanical, engineering, electronic and/or software driven applications, while pharmaceutical products are broadly derived from organic/inorganic chemistry principles.
Within the document itself, consideration and application of risk management principles are the most significant changes, with risk acting as an overarching umbrella across the standard. The standard now takes into account the mechanical, physical and engineering nature of devices through normative referencing to another ISO standard, namely ISO 14971: Application of Risk Management to Medical Devices. The importance of this normative reference (another ISO standard incorporated by reference into the primary standard) to ISO 14971 cannot be overemphasised. This establishes the requirement for risk management to determine the safety of a medical device by the manufacturer as part of the product lifecycle management process.
Among other changes, ISO 14155:2011 also:
- Recommends that the content of the investigator’s brochure for medical device trials reflect the mechanical nature and performance of the device rather than just cover the mode of action.
- Expands safety evaluation and reporting requirements of medical devices.
- Requires the sponsor to review, investigate and document device deficiencies with respect to the impact on patient safety.
Putting it into practice
Compliance with implementation of this standard could prove difficult, but it is possible with a thorough review of the provisions and deciding upon how best to adhere to the new guidelines.
Before implementing the updated requirements, it is necessary to define how these changes will impact the company business pertaining to clinical investigations of medical devices. To this end, an individual business review of the standard is needed, particularly assessing its impact and considering any potential integration into existing systems, policies and procedures, and business models.
The preceding article is drawn with permission from the British Association of Research Quality Assurance (BARQA) and was first published in the April 2012 edition in its member magazine, Quasar. Terry Airlie, PPD’s manager, quality assurance, global quality and compliance, co-authored the article.