Essentials of European Medical Device Regulatory Affairs - June 2020

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 (if marketing before May 2021) and MDR. Plan for any change.

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Reclassification Process MDD Art. 9.3.

Where a Member State considers that the classification rules set out in Annex IX require adaptation in the light of technical progress and any information which becomes available under the information system provided for in Article 10, it may submit a duly substantiated request to the Commission and ask it to take the necessary measures for adaptation of classification rules.

MDR Article 51 3.

Commission can also decide by an implementing act to reclassify

Process can be used to avoid divergence of opinion

TheOrganisation for Professionals in Regulatory Affairs

EU Directives for Reclassification • Reclassification of breast implants: http://eur- lex.europa.eu/LexUriServ.do?uri=OJ:L:2003:028:0043:0044:e n:PDF • Reclassification of hip, knee and shoulder joint replacements: http://eur- lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2005:210:0 041:0043:en:PDF

TheOrganisation for Professionals in Regulatory Affairs

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