20 Requirements for the surfaces of medical devices and instruments • Disinfectability and durability • Resistance to disinfectants • Disinfectant performance • UDI durability Disinfectability and durability of surfaces on medical devices and instruments The new EU regulation for medical devices (Medical Device Regulation – MDR 2017/745) has been in force since May 25, 2021. New devices require authorization under this regulation and can no longer be placed on the market under the “old” Directive 93/42/EEC. Anyone who develops, produces, and places medical devices on the market is considered a manufacturer, and any obligations they must comply with are formulated in Article 10 of 2017/745, also known as the Medical Device Regulation (MDR). New devices must be approved according to this regulation and can no longer be placed on the market according to the “old” directives 93/42/EEC (Medical Device Directive, MDD) or 90/385/EEC (Active Implantable Medical Device Directive, AIMDD). There is great deal to consider and be set out in the MDR, and all of this (and more) needs to be taken into account when medical devices are to be placed onto the market or when an authority announces that the documents are to be examined. What looks superficially like a manageable change from the MDD/AIMDD to the MDR can have serious consequences for the companies concerned. For example, the MDR now increasingly requires evidence such as material testing for cleaning or disinfection processes, transport validation, a biological evaluation according to the new ISO 10993-1, updating of the clinical ENGLISH Authors: Dr. Wolfgang Sening, CEO Philip Eschenbacher, Head of R&D, Senior Consultant Regulatory Affairs & Quality Management senetics healthcare group GmbH & Co. KG Hardtstraße 16, 91522 Ansbach, Germany E-Mail: info@senetics.de Web: www.senetics.de
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