A Notified Body’s perspectives on progress made in transitioning combination products to the MDR

English

In May 2020, Dr Jonathan Sutch wrote an article in the Journal of Medical Device Regulation that outlined the regulatory pathways and discussed the potential challenges for combination products of the incoming Regulation (EU) 2017/745 on medical devices (MDR). The purpose of this current article is to provide an update on the status of the implementation of the MDR with respect to combination products based on the considerable experience gained since the entry into force of this legislation. Specifically, Dr Sutch provides an update on the implementation of Article 117 for integral drug/device combinations, Rule 14 for device/drug combinations and Rule 21 for substance-based devices.

Specification: 9 pages plus covers, in English, supplied by email as a PDF.

This article has been published in the February 2025 issue of the Journal of Medical Device Regulation.