EU MDR Compliance
For Medical Device Manufacturers
GreenSoft provides the critical substance data you need to comply with the EU Medical Device Regulation (EU MDR) through our expert supply chain data collection, validation, and compliance software solutions.
Supply Chain
Data Collection
Regulatory
Screening
Compliance
Monitoring
Project
Management
Navigating Strict EU MDR Requirements
Mandatory since May 2021, the EU Medical Device Regulation (MDR) imposes strict rules on medical devices sold in the EU. Manufacturers must verify that their products do not exceed 0.1% w/w of carcinogenic, mutagenic, or toxic for reproduction (CMR 1A/1B) substances or endocrine-disrupting substances (EDS) without justification. Latex and substances of human or animal origin must also be disclosed.
Meeting these requirements demands extensive supply chain data collection and analysis — a complex, resource-intensive task.
We collect supply chain data for you
We contact your suppliers directly to collect data on the presence of EU MDR regulated substances in your products and provide the data you need for submission to the UDI database and evaluation by a notified body for approval.
Hands-On Data Collection & Validation
We collect and validate detailed substance data from your suppliers, including animal- and human-derived materials.
Regulatory Screening
Using GreenData Manager (GDM) software, we cross-check your product data against the list of CMR 1A/1B and EDS substances restricted under EU MDR.
Compliance Monitoring
We monitor regulatory updates and notify you of changes affecting your products.
Expert Project Management
A dedicated Project Manager is assigned to your project to provide bi-weekly status updates and keep your project on track.
Data Sheet
Simplifying Substance Data Collection with GreenSoft’s EU MDR Solution
GreenSoft's EU MDR solution provides the substance data you need for submission to the UDI database and evaluation by a notified body for approval, freeing you up to focus on other elements of the approval process.
A New Standard for Medical Device Compliance
Published in 2017, the EU Medical Device Regulation (MDR) replaced the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive.
EU MDR changed how medical devices are defined and how devices are classified for risk, created a new labeling system, and includes substance content requirements.
Why Choose GreenSoft?
A Trusted Partner for Medical Device Manufacturers
With over 20 years of experience, GreenSoft supports medical device manufacturers of all sizes. We have expertise in active and passive components, electrical and mechanical parts, packaging, and raw materials.
Fast & Reliable Data Collection
Our extensive component database of over 97 million parts allows us to streamline the data collection process. By analyzing your BOM or parts list, we quickly identify components with existing validated compliance data, reducing time spent on supplier outreach.
Hands-on Collection Provides the Highest Quality Data
At GreenSoft, real people from our Data Team contact your suppliers directly and follow up as many times as it takes to collect full and accurate data. This process of manual checks combined with automated processes guarantees higher quality data and higher project completion rates.
Ready to simplify your EU MDR reporting process?
Manage MDR Data with GreenData Manager
EU MDR is one of 27 Environmental Regulations included in GreenData Manager® (GDM), the premier software solution for compliance data management, storage, and reporting.
Store and manage all MDR data collected from your suppliers in one place.
Effortlessly generate compliance reports at the company-level, product family-level, or product-level.
Seamless integration into your existing PLM or ERP system.
Create a materials database for your company that can be used for all regulations.
EU MDR Resources
DATA SHEET
Compliance Data Services for the EU MDR
GreenSoft's EU MDR solution provides the substance data you need to enable your product to be submitted to the UDI database and evaluated by a notified body for approval, freeing you up to focus on other elements of the approval process.
VIDEO
Substance Requirements of the EU Medical Device Regulation (EU MDR)
Learn about the various substance and labelling requirements affecting medical device manufacturers under the EU Medical Device Regulation (EU MDR).
WHITE PAPER
Environmental Compliance Data Services
Collecting environmental compliance information is a tedious and resource intensive process. GreenSoft offers a better way to complete the data collection and verification that is needed to comply with required regulations.