EMA: Revised Q&As on Implementation of MDR and IVDR
The EMA has published a new revision of the guidance available to applicants, marketing authorisation holders and notified bodies of medical devices. This question-and-answer document provides practical considerations on the implementation of the medical devices and in vitro diagnostic regulations (MDR and IVDR) for combinations of medicinal products and medical devices.
The document covers regulatory and procedural guidance for:
- Integral drug-device combinations (medical devices that form an integral product with a medicine, such as pre-filled syringes) and their lifecycle management;
- Medicinal products that include a medical device in their packaging (referred to as co-packaged) and how these should be labelled;
- The consultation procedure for medical devices with an ancillary medicinal substance (a substance that supports the proper functioning of the device) and;
- The consultation procedure for companion diagnostics, diagnostic tests that are essential for the correct use of a specific medicine.
Source:
EMA: Medical devices
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