Compliance with New EU Medical Devices Regulation (EU MDR) Becomes Mandatory in May 2020
In May 2017, the EU Commission published the Medical Devices Regulation (MDR). The regulation becomes mandatory for medical device producers as of May 26, 2020.
The EU MDR replaces the previous Medical Device Directive (EU MDD) and Active Implantable Medical Device Directive.
EU MDR changes how medical devices are defined, how devices are classified for risk, and creates a new labeling system. The regulation also includes certain substance content requirements.
Under the new EU MDR, medical devices cannot contain substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR 1A/1B) or endocrine-disrupting substances (EDS) in amounts over 0.1% w/w without justification. The use of latex, as well as substances of human or animal origin, must also be declared if present.
Get Help With Substance Data
As part of our Data Services, we will collect substance data from your suppliers on your behalf, and check it against the lists of applicable CMR 1A/1B and endocrine-disrupting substances addressed under the EU MDR, using our powerful, purpose-built GreenData Manager compliance software.
Plus, we will track the regulations you are complying with for updates and new substance additions and alert you when there are changes to ensure you are always showing up-to-date compliance.
We can even collect information on the presence of animal and human derived materials, as well as latex, as required by the EU MDR.
GreenSoft Technology: A Trusted Partner
At GreenSoft, we have over 15 years of experience in managing compliance data.
We currently work with many medical device manufacturers of all sizes.
We have a broad range of expertise in active and passive components, electrical and mechanical parts, packing and printing materials, and raw materials including organic or non-organic chemicals. GreenSoft has relationships with over 32,000 suppliers worldwide and is ISO 9001:2015 certified.
Contact Us Today to Learn More and Get Started
Our EU MDR Data Services provide you with the substance data you need to enable your product to be submitted to the UDI database, and evaluated by a notified body for approval, while freeing up your time to focus on other elements of the product approval process.
Bonus: don’t miss our EU MDR webinar in November!