New Guidance for Medical Devices and Medicines

The European Medicines Agency (EMA) has released a revised question-and-answer document to aid manufacturers, regulators, and notified bodies involved with medical devices used alongside medications. This document offers practical guidance on implementing regulations for these combination products.

Combination Products: Which Regulations Apply?

Previously, regulations for products combining a medicinal product (drug) and a medical device depended on the product’s primary function. This revision clarifies regulations for:

• Integral Drug-Device Combinations: These are medical devices that function as a single unit with a medicine, like pre-filled syringes. The guidance covers managing these products throughout their lifecycle.
• Co-Packaged Medicinal Products: These are drugs with a medical device included in the packaging (e.g., inhalers). The document clarifies labeling requirements for these products.
• Medical Devices with Ancillary Medicinal Substances: These are devices that include a supporting medicinal substance (e.g., a coating that enhances device performance). The guidance outlines the consultation process for such devices.
• Companion Diagnostics: These are diagnostic tests crucial for using a specific medicine correctly. The document details the consultation procedure for companion diagnostics.

New Regulations and Responsibilities

The guidance supports the application of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). These regulations revamped the legal framework for medical devices in Europe, assigning new responsibilities to the EMA and national authorities for specific medical device categories used with medications. This revised document incorporates experience gained since implementing the new regulations and addresses real-world scenarios encountered.

Related Documents:
Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)
Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) – tracked changes