Medical Devices
In today’s rapidly evolving healthcare landscape, medical device manufacturers face the dual challenge of driving innovation while ensuring regulatory compliance.
MDCG
The final article of the cycle highlights the key points related to certain specific product categories, outlining the most important aspects to be taken into consideration.
MDCG
The new article provides an overview of the regulatory status of accessories and related products as set forth under the existing legal framework.
EU
The article highlights the key points related to the regulatory status of in vitro diagnostic medical devices under the existing legal framework.
Medical Devices
The European Union Medical Device Regulation (EU MDR) significantly reshaped the landscape for medical device manufacturers, introducing stringent regulatory requirements aimed at enhancing patient safety and device efficacy. Enforced since May 2021, the MDR replaced the older Medical Device Directive (MDD), demanding greater transparency and accountability from manufacturers operating within the EU market.
Gartner® Market Guide for Life Science Regulatory Information Management Solutions
Download NowGartner® Market Guide for Regulatory Intelligence Solutions
Download Now
