Medical devices: new guidelines for industry and notified bodies

New revision of the guidelines available to applicants, marketing authorization holders AND notified bodies medical devices was published today. This question and answer document provides practical considerations on the use of medical devices and in vitro diagnostic recipes for combinations medical products and medical devices.

Connecting Products a medicinal product (or substance) and a medical device are subject to either the Pharmaceuticals Framework or the Medical Devices Framework, depending on their main mode of action. The revision is based on experience gained since the implementation of the new regulations and real cases. The document includes regulatory and procedural guidelines regarding:

• integral drug-device connections (medical devices that are an integral drug product, such as pre-filled syringes) and their life cycle management;
• medical products which contain a medical device in their packaging (called collectively packaged) and how they should be labeled;
• medical device consultation procedure with auxiliary medicinal substance (a substance that supports the proper functioning of the device) and;
• consultation procedure regarding accompanying diagnostics and diagnostic tests necessary for the proper use of a specific drug.

These guidelines aim to support the application of the regulations on medical devices (Regulation (EU) 2017/745) and on in vitro diagnostic devices (Regulation (EU) 2017/746). These two regulations changed the European legal structure for medical devices, introducing new obligations and requirements for the EMA and competent national authorities when assessing certain categories of medical devices used in combination with medicines.