24 May 2024
Medical devices: new guidance for industry and notified bodies
A revised guidance for applicants, marketing authorisation holders, and notified bodies on combinations of medicinal products and medical devices has been published. It provides regulatory and procedural guidance for integral drug-device combinations, co-packaged products, and consultation procedures for devices with ancillary substances and companion diagnostics. This guidance supports the implementation of the regulations on medical devices (Regulations (EU) 2017/745) and on in vitro devices (Regulation (EU) 2017/746), which have changed the European regulatory framework for medical devices and introduced new responsibilities for EMA and national authorities.
For more information, see here.
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