Navigating the Regulatory Landscape for Drug-Device Combinations

Key highlights and compliance essentials from EMA (European Medicines Agency)

A new revision of Questions & Answers for applicants, marketing authorization 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 (EU) 2017/746) has been published.

This Question and Answer (Q&A) document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations in the context of combinations of medicinal products with medical devices. 

Here are the main points from the document: 

1. Regulatory framework: The document outlines the regulatory framework for products combining medicinal products and medical devices under Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). 
2. Integral products: It defines integral drug-device combinations (iDDCs) and the conditions under which they are regulated as medicinal products or medical devices. 
3. Notified Body requirements: Details the requirements for obtaining an EU declaration of conformity or a certificate of conformity from a notified body for certain medical devices. 
4. Consultation Procedures: Explains the consultation procedures for ancillary medicinal substances and companion diagnostics, including the roles of the EMA and national competent authorities. 
5. Article 117: Highlights the impact of Article 117 of the MDR on marketing authorisation applications for iDDCs, requiring evidence of compliance with general safety and performance requirements. 
6. Post-authorisation changes: Provides guidance on handling changes to the device part of an iDDC after initial marketing authorisation, including when new or updated notified body opinions are needed. 
7. Co-packaged devices: Discusses the requirements for medical devices co-packaged with medicinal products, including labelling and conformity assessment. 
8. Minor changes: Outlines the process for submitting minor changes to the marketing authorisation for integral DDCs following changes to the device. 
9. Transitional provisions: Mentions the transitional provisions for devices with certificates issued under previous directives, allowing continued market placement under certain conditions. 
10. Unique Device Identifier (UDI): Clarifies that iDDCs falling under medicinal products legislation do not need to meet MDR obligations related to UDI. 

To ensure Compliance and Safety in the Integration of Medicinal Products and Medical Devices do not forget to read this document:

Source:  https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf