Medizintechnologie e.V.
Reinhardtstr. 29 b
D - 10117 Berlin
Tel. (030) 246 255 - 0
Fax. (030) 246 255 - 99
info@bvmed.de
CE-Kennzeichnung
CE-Informationsflyer jetzt auch auf Englisch erschienen
Der englische Pressetext:
“The meaning of CE on medical devices”: New information flyer now available in English
BVMed, the German Medical Technology Association, recently issued an information flyer on the meaning of the CE marking for medical devices in English together with the German industry associations BAH, BPI, SPECTARIS, VDDI, VDGH and ZVEI.
The flyer points out the German legal particulars and objections to additional private marks of quality, safety and efficiency, arguing that the European "Blue Guide" (Guide to the Implementation of Directives based on the New Approach and the Global Approach) allows for additional marks only if they fulfil a different function from that of the CE marking.
Medical devices are subject to the laws and regulations which were enacted when the European Directives became national law with the German Medical Devices Act (Medizinproduktegesetz - MPG). As a consequence, all medical devices are subject to the strict and extensive Essential Requirements and quality assurance measures detailed in the directives.
Compliance with these comprehensive legal requirements ensures a high degree of health protection, performance and safety while assuring quality for patients, users and third parties.
The CE marking establishes that the manufacturer's product conforms to all applicable legal requirements. Depending on the product’s risk level, a Notified Body must be employed. The Notified Body's identification number accompanies the CE marking. The fulfilment of all legal specifications must be proven in a conformity assessment procedure, which for medical devices means:
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Safety: risks and side effects are analysed, assessed and minimised; biocompatibility is ensured while reducing or eliminating risk of infection; mechanical, electrical and electromagnetic safety is ensured; product combinations are allowed or forbidden; safety instructions and instructions for use are reviewed for completeness and comprehensibility. |
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Performance and benefit: compliance with specified product characteristics and specifications; therapeutic or diagnostic benefit is ensured; clinical or diagnostic evaluation of medical devices; measuring accuracy is ensured. |
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Monitoring of the manufacturer and of the medical device during the entire life cycle of a product. |
Based on these facts, the CE marking which is legally applied to medical devices is a symbol of quality, safety and efficiency.
The flyer can be downloaded on the Internet at www.bvmed.de (publications – medical devices legislation). Direct link: http://www.bvmed.de/publikation.php?5&l=2.
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