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 Publication
  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 MedTech Industry
  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.

If you require further information on any aspect of the MDR, please contact Charleen O’Keeffe or Laura Scott.