Medizinische Produkte der Klasse I müssen beim Inverkehrbringen über eine Konformitätserklärung, verfügen, die der Konformitätserklärung anderer elektrotechnischer Produkte entspricht. Medizinische Produkte einer höheren Klasse als I nach RV 54/2015 Slg. benötigen für das Inverkehrbringen eine Beurteilung durch die benannte Stelle
Ing. Martin Novotný
Regierungsverordnung Nr. 54/2015 Slg. – Richtlinie 93/42/EWG, 2007/47/EG des Rates für medizinische Produkte.
Regierungsverordnung Nr. 481/2012 Slg. zur Beschränkung der Verwendung bestimmter gefährlicher Stoffe in Elektro- und Elektronikgeräten.
Zertifizierung der Qualitätsmanagementsysteme nach der Norm ČSN EN ISO 13485:2012
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