EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2015

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16 | Spring 2015 European Medical Device Technology emdt.co.uk regulatory Adverse Event Reporting in European Premarket Clinical Studies Sponsors of clinical studies that are unaware of the variations in adverse event reporting that occur during European medical device premarket clinical studies risk delays and unplanned resource expenditures. A All serious adverse events (SAEs) must be fully recorded and imme- diately reported to all Competent Authorities of EU member states in which the clinical study is being conducted, according to Annex 7 of the Active Implantable Medical Device Direc- tive (AIMDD) and Annex X of the Medical Devices Direc- tive (MDD). However, no further detail on how these requirements should be met nor a definition of what constitutes "imme- diately" is provided in either the AIMDD or MDD. Fortunately, the European harmonized standard for clinical investigations, EN ISO 14155:2011, specifies the actions that sponsors and investigators should take to manage and report adverse events that occur during medical device clinical stud- ies, including device deficiencies that must be reported. The European guideline on SAE report- ing—"Guidelines on Medical Devices, Clinical Investigations: Serious Adverse Event Reporting under Directives 90/385 and 93/42/EEC"—also describes the recommended procedures for reporting SAEs and device deficiencies. In addition, it addresses the Competent Authorities, to whom reports should be submitted; report- ing timelines; reporting of an adverse event in a third country when the third country and European clinical sites are covered by the same clinical investigation plan; and information on the reporting form that is included in an Appendix. It should be noted, however, that this guideline was published in December 2010, which preceded the release of EN ISO 14155:2011. Thus, the definitions found in the guideline were based upon definitions in the final draft standard, which differ slightly from the final version of the standard. For this reason, companies should consider the definitions in ISO 14155:2011 as official and apply those definitions to their European clinical study procedures and documentation. According to the European SAE guide- lines, SAEs are to be reported simultane- ously to all national Competent Authorities of the Member States in which the clini- cal investigation has commenced using the summary tabulation provided in the Appendix. The sponsor is to report the following: 0 An SAE—which indicates an imminent risk of death, serious injury or serious illness and that requires prompt reme- dial action for other patients, subjects, users or other persons—or a new finding related to the SAE. These issues must be reported immediately, defined as no later than two calendar days after the sponsor becomes aware of a new reportable event or of new information in relation to an event already reported. 0 Any other reportable events—including reportable device deficiencies—or a new finding or update to an already reported event. The events or findings must be reported immediately, specified in this case as no later than seven calendar days following the date that the sponsor Maria Donawa

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