EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2015

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18 | Spring 2015 European Medical Device Technology emdt.co.uk regulatory Barbed Fittings Luers Check Valves Inline Filters Stopcocks Tubing Custom Components Our motto Expect Excellence is more than just a corporate slogan, it's a customer guarantee. Ark-Plas specializes in the manufacture of over 4000 stock plastic components and custom part engineering. Let us help solve your unique problems with over thirty years of injection molding and extrusion experience. Call today 870.453.2343 | www.ark-plas.com Swiss Reporting Requirements Swissmedic, the Swiss Competent Author- ity for medical devices, has published an information sheet on the authorization, notification and reporting for medical device clinical studies. Section 7.2.3 of the information sheet lists the criteria for determining whether an event is serious and therefore reportable, guidance on determining whether or not the event could be related to the study device, time- lines for reporting, the forms to be used for reporting, and other advice regarding the management of SAEs. Timelines for reporting to Swissmedic are not exactly the same as those specified in the European SAE guideline in that SAEs and reportable device deficiencies— termed "Events (serious and not obviously unrelated)"—must be reported to Swiss- medic within seven days. If such an event takes place in a Swiss study center, a special Swiss form should be used, which is available from the Swissmedic Web site. However, for SAEs occurring in multi- center studies, a report form in accord- ance with the European SAE guideline must also be submitted. This Excel table must be completed cumulatively over the course of the study. Italian Reporting Requirements Of the examples provided, the Italian Ministry of Health (Ministero della Salute), is the only Competent Authority that accepts the reporting of SAEs and reportable device deficiencies occurring in a premarket medical device clinical study in accordance with the European SAE guideline without any deviation or variation. Need for Reporting Plans Sponsors of European medical device clinical studies, especially studies con- ducted in more than one European member state, need to develop a Serious Adverse Event Reporting Plan as soon as possible in the study planning process. Plans should: 0 Specify the reference regulations and standards 0 Identify the countries where the study will be conducted 0 Include relevant definitions 0 Outline sponsor and investigator reporting responsibilities, reporting flow diagrams or explanations, and other information that will ensure that all parties understand the reporting requirements applicable to all coun- tries where the study is being con- ducted. Prudent sponsors will ensure that such a plan is developed before the first patient is enrolled in the clinical study. Maria E. Donawa, MD, is the president of Donawa Lifescience Consulting. www.egtechnology.co.uk Cambridge, UK +44 (0)1223 813184 info@egtechnology.co.uk Transforming ideas into successful products eg technology is an innovative and creative product design and engineering company that transforms ideas into successful products. We provide a professional engineering design service taking projects from concept through to transfer to manufacture. We are ISO13485 accredited and the applicable design process is rigorously implemented against each individual project to ensure risk, cost and time to deliver projects is PDQDJHGHHFWLYHO\DQGHɝFLHQWO\ See us at MEDTEC Europe Stand #7C18

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