CRED ERP 25

device itself, what alternative solutions could be considered to display the labelling requirements? New May 2024 .................................................................................. 19 3.3. Do I need to submit a declaration of conformity / EU certificate as part of the dossier for a co-packaged medical device? Rev. May 2024 ........................................................... 20 3.4. What actions, if any, do I need to take if my co-packaged device is up-classified and requires to be certified by a notified body for the first time? Rev. May 2024 .................... 20 4. Consultation procedure for ancillary medicinal substances in medical devices (Art 1(8)) ..................................................................................... 21 4.1. What type of consultation procedure needs to be carried out for an ancillary medicinal substance that has already been consulted under the medical device Directive 93/42/EEC? Rev. May 2024 ....................................................................................................... 21 5. Consultation procedure for companion diagnostics ............................... 22 5.1. What type of consultation procedure needs to be carried out for a companion diagnostic New May 2024 ....................................................................................................... 22

Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (E EMA/37991/2019 Rev.4

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