Essentials of European Medical Device Regulatory Affairs - October 2019
EU Directives for Reclassification • Reclassification of breast implants: http://eur- lex.europa.eu/LexUriServ.do?uri=OJ:L:2003:028:0043:004 4:en:PDF • Reclassification of hip, knee and shoulder joint replacements: http://eur- lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2005:21 0:0041:0043:en:PDF
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MDR-Classification Annex VIII
• 22 rules (4 extra versus MDD)
• Rule 11 software
• Rule 19 nanomaterials
• Rule 20 All invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation • Rule 21 Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body
• Review your product under MDD and MDR. Plan for any change.
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