ISO 14155 2011 Major Changes – SAFETY
March 31 2011
The revised standard ISO14155 - has a new title - Clinical Investigation of Medical Deices for human subjects - Good Clinical Practise. This reflects its closer relationship with international good clinical practise regulations and guidelines. Manufacturers should be aware of these changes, one of the main changes is around safety evaluation and reporting.
In clause 8.2 of the 2003 previous version of the standard, the sponsor ensured that all adverse events and all adverse device effects were reported to and reviewed by the clinical investigator(s) and where appropriate, all serious adverse events and all serious adverse device effects had to be reported to the relevant authorities, ECs and/or safety monitoring committee(s). In addition, during the clinical investigation the sponsor informed in writing all principle clinical investigators about all serious adverse events and all serious adverse device effects occuring in (multicentre) clinical investigations that had been reported to the sponsor. It was also stated that this information must be sent to the clinical investigator(s) based on perceived risk.
However in clause 8.2.5, safety evaluation and reporting in the revised standard states that the sponsor is responsible for the classification of adverse events and ongoing safety evalution of the clinical investigation. It expands the safety evaluation and reporting requirements in very important ways, listing eight actions that must be taken instead of the two specified in the 2003 version of the standard; an important activity concerns a new category of safety data and device deficiencies. That is within clause 8.2.5(b) and requires the sponsor to review all device deficiencies and determine and document in writing whether they could have led to a serious adverse device effect. Device deficiency is a new concept in the management of clinical studies and fills a gap regarding an important source of data on medical devices used in clinical studies.