The new Medical Devices Regulation (MDR) and In Vitro Diagnostic
Medical Devices Regulation (IVDR) represent a long-awaited
strengthening of the existing European regulatory system for
The Regulations will take full effect from 26 May 2021 and 26 May 2022 respectively. Over the coming years, compliance with the Regulations represents a real challenge for the MedTech industry. Our team of regulatory experts is up to speed with the Regulations and ready to assist companies in meeting this challenge.
To assist medical device companies navigate the new MDR & IVDR regulatory regime we have 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.
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.