With innovation leading to the increasing integration of drugs and devices, traditional boundaries between medicines and medical devices are often blurred. As a result, determining the correct regulatory pathway for drug-device combination products (DDCs) can prove challenging.
The development of these products involves interaction between EU and national regulations, one of which, the Medical Devices Regulation (MDR), is set to become fully applicable on 26 May 2021.
In this briefing we examine the key changes to the regulatory pathway for DDCs.
Click here or on the image below to download this briefing, or click the following links to view the rest of our series:
- Our Medical Devices
To assist medical device companies navigate the new MDR & IVDR regulatory regime we published under one roof the Regulations with easy access to the annexes and a table of equivalence comparing key articles from the Medical Devices Directives 93/42/EEC and 90/385/EEC and In Vitro Diagnostic Medical Devices Directive 98/79/EC with the MDR & IVDR.
- Low Rate of Notified Body Designations
under MDR and IVDR Causes Bottleneck Concerns for the European
We explore which EU Notified Bodies have been designated under the new Medical Devices and In-Vitro Devices Regulations, and the slow pace of approval despite increased demand for their services.
- Act Now to be Ready on Time – Guide
to New Classification Rules for In Vitro Diagnostic Medical
We outline the key changes to the classification of in vitro diagnostic medical devices in advance of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) becoming fully applicable on 26 May 2022.
- Medical Devices – New Classification
Rules – Is your Business Ready?
A guide to the classification of devices under the new Medical Devices Regulation.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.