Amidst much anticipation, the Medical Devices Regulation becomes fully applicable across the EU from today, 26 May 2021. These Regulations represent a long-awaited strengthening of the European regulatory system for medical devices.
Our team of regulatory experts have examined various aspects of the new regulatory framework. Click the following links to view our briefings:
- MDR Countdown – 1 Month. European
Commission Updates its Rolling Plan
We summarise the key recent updates to the Commission's Rolling Plan for the implementation of the MDR.
- Drug-Device Combination Products: where do
they fall within the new MDR regime?
We examine the key changes to the regulatory pathway for drug devices under the MDR regime.
- Our Medical Devices Regulations
We have published under one roof the MDR and IVDR 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.
- 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.