20 Manufacturers of Class I devices vs. MDR • An introduction to the basics for Class I manufacturers. It’s good to have thought of everything if the authorities want to see the documentation. • And new! Biological evaluation according to ISO 10993 Manufacturers of Class I devices vs. MDR – thought of everything? The luxury of not being dependent on a Notified Body when obtaining marketing authorisation for proprietary medical devices sounds tempting at first glance, but essential parts can easily be overlooked if there is nobody “watching your back”. Many surgical instruments used to be Class I under the MDD. But first things first: The introduction of the Medical Device Regulation (EU Regulation 2017/745; MDR for short) on 26 May 2021 brought a slew of regulatory reforms to which Member States are now subject, even if the provisions do not have to be transposed into national law. Although the underlying tone of the MDR is similar to the preceding directive, it is primarily stricter, more detailed and more “modern”. This is particularly evident in the General Safety and Performance Requirements in Annex I of the MDR, which now also address, or in some cases even include for the first ENGLISH Authors: Dr. Wolfgang Sening, CEO Philip Eschenbacher, Head of R&D, Senior Consultant Regulatory Affairs & Quality Management Dr. Patrick Hansmann, Deputy Head 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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