The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe. Compliance with this new regulation is mandatory for all medical device companies that want to sell their products in the European market.
The Medical Device Regulation was oﬃcially published on May 5th 2017 and came into force on May 25th 2017. Medical devices companies like Medtronic have had a transition time of three years until May 26th 2020 to meet the requirements of this regulation.
Include devices with non-viable human tissue/cells or non-medical purpose
Increased oversight of notified bodies
Clinical data, hazardous substances, cybersecurity
Implmentation of the Eudamed database and UDI device registration
Nanomaterials, closed-loop systems
Definition of responsibilities and requirements within the supply chain
Create a harmonized approach in the EU
This regulation brings forth a set of new standards and requirements with which our products need to comply.
Some of our products cannot be made MDR compliant which means they will be either phased out or replaced by an appropriate alternative.
Click any of the button below to access more information about MDR or if you would like our local sales representative to provide you a complete overview of the impacted products and the proposed alternatives.