EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2014

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emdt.co.uk European Medical Device Technology Spring 2014 | 25 Articles 50 through 60 and Annex XIV of the proposed regulation for medical devices specify the requirements for conducting clini- cal investigations for regulatory purposes. According to paragraph 1 of Article 50, one of the purposes for a clinical investigation is, "to verify that devices achieve the intended benefits to the patient as specified by the manufacturer." In contrast, EP amendment 175 states that the purpose is, "to verify the clinical safety and efficacy of the device, including the intended benefits to the patient, when used for the intended purpose, in the tar- get population and in accordance with the instructions for use." Thus, the EP has introduced a require- ment for efficacy into the European medical device regulatory system, which, since its inception, has been based upon essential requirements for safety and performance, where device-related benefits must outweigh any risks of use. It should be noted that no definition for "efficacy" has been included in the EP text as if there were only one meaning of the term, which is clearly not the case. Proposed Streamlined Process Article 51, Application for Clinical Investiga- tions, specifies that the sponsor must obtain a single identification number for the clini- cal investigation from an electronic system, and use this number to register the clinical investigation. According to the Article, there is no stipulation that the approval process requires the favorable approval of an ethics committee, which is demanded under the current MDD and AIMDD. This would be a significant change from current requirements concerning the approval process for con- ducting a premarket clinical investigation. Instead, there is a requirement that at least one person whose primary area of interest is nonscientific must be taken into account in the assessment process, and the view of at least one patient must also be taken into consideration. This is an attempt to align the medical device clinical investigation approval process with the Commission's Proposal for a regula- tion on clinical trials for medicinal prod- ucts 4 , which would allow Member States to define the national process for the approval of clinical studies. The members of the EP indicate disagreement with this approach as they specified in amendment 181 the require- ment to involve an independent ethics com- mittee in the approval process. Temporary Halt or Study Termination Article 57 specifies the timelines in which sponsors need to inform Member States of a temporary halt of a clinical investiga- tion on safety grounds, the end of a clinical investigation, or early termination. The Commission's proposal requires the spon- sor to notify each Member State concerned, providing a justification in the event of early termination. EP amendment 189 adds a reason for this notification: "So that all Member States can inform sponsors con- ducting similar clinical investigations at the same time within the Union of the results of that clinical investigation." This would necessitate a determination presumably by the Member State of what constitutes a similar investigation. Any perceived ben- efits of this EP proposal clearly must be evaluated against the resources needed for implementation. Obsessed with perfection? Like next-generation, bioresorbable polymer scaffolds, perhaps? Learn more at www.resonetics.com or call 603.886.6772 to speak to an expert. The experts in micromachining polymers So are we, with more than 25 years of experience laser micromachining polymers for the life sciences market, where products can require features as small as 1 micron. Whether laser machining the worldÕs most advanced stents or drilling holes small enough WRÀOWHULQGLYLGXDOEORRGFHOOVZH·UH SURXGWREHDELWREVHVVHG Copyright © 2014 Resonetics. All rights reserved. 1000 µm 30 µm 90 µm Laser drilling Laser stripping ES430754_EMDT1405_025.pgs 04.29.2014 03:27 UBM black yellow magenta cyan

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