Adjusted regulation for class I medical devices in drug-device combinations with regard to the confirmation of conformity with MDR 2017/745, Annex I.

The guidance document of the EMA on the implementation of the Medical Devices and in vitro Diagnostic Regulation in drug-device combinations has been updated.

Drug-device combinations (medicinal products with medical devices) require either a confirmation that they correspond to Annex I of the general safety and performance requirements of the MDR or IVDR for the medical device part. This can be in the form of a valid certificate of conformity or a Notified Body Opinion for the specific ‘drug-device combination’. If a declaration of conformity is missing for class I products (except class Im and class Is), a declaration by the MAH (Marketing Authorisation Holder) is now acceptable (MAH’s GSPRs compliance statement), which proves the compliance of the medical device with the general safety and performance requirements of the MDR, Appendix I. The questions and answers of the EU numbers 2.2., 2.4., 2.6., 2.7., 2.8., 2.10. and 2.11. have been adapted accordingly.

*“Questions & Answers with respect to the implementation of the regulations 2017/745 and 2017/746”

Update of the Q&A-document* concerning MD’s in drug-device combinations

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