The EU Medical Device Regulation
The EU Medical Device Regulation (MDR) requires supply chain reporting to maintain market access. Assent supply chain sustainability platform helps complex manufacturers get there.
Complying With the EU Medical Device Regulation
The EU MDR establishes a regulatory framework for medical devices that safeguards public health and safety while supporting the competitiveness of the market. The regulation places restrictions and reporting requirements on substances used in the design and manufacture of medical devices, and the substances in scope of the regulation change frequently.
Manufacturers need to know when a substance is added and when substances used in their parts change. While this data can be difficult to collect from suppliers, the alternative is costly — enforcement actions can be taken by every EU member state for a single infraction.
Don’t Just Meet Your Requirements — Start Outdoing Them
While rules under RoHS are well-established, labeling requirements can be complicated, data can be difficult to collect, and the actual data you need often changes as exemptions expire, new substances are restricted, and parts are altered.
Assent’s solution was built in collaboration with supply chain and regulatory experts, giving you the deep insights you need to avoid costly enforcement action despite complex requirements — and continue your company’s growth in the EU.
The Risks of EU MDR Non-Compliance
Requirements under the EU MDR are stringent, but failure to comply could result in lost market access, product recalls, and lawsuits if complications arise from non-compliant products. Without Assent’s deep-mapping of your supply chain, due diligence is complicated and costly. You may also face delays in material sourcing due to supply chain disruptions and reputational damage.
Understanding the EU Medical Device Regulation
How steep is the cost of EU MDR non-compliance? A French company was fined $85,000 USD and five employees were criminally charged after it was discovered that their implants contained industrial-grade silicone.
This eBook explains how to achieve EU MDR compliance, medical device classifications, the difference between the former medical regulation and the new EU MDR, and best practices for maintaining market access.Get the Ebook
Our EU MDR Solution Capabilities
Advanced Data Management
Assent automates data collection and roll-up reporting on hidden EU MDR risks in your supply chain.
Automate queries to suppliers when new substances come in scope of the EU MDR, and minimize supplier fatigue by streamlining duplicate data collection.
Assent’s detailed dashboards and reports help you uncover hidden risks and opportunities in your supply chain, with parts data organized in one central database.
The Assent Advantage
Assent is the only supply chain sustainability platform built specifically for complex manufacturers, allowing you to continuously map and monitor suppliers, products, parts, practices, and regulations. As a complete turnkey solution, our platform helps manufacturers stay on top of the SVHC list by triggering additional data collection when the list or parts are updated.
Solutions for Product Compliance
Explore our solutions for getting standardized, validated, and usable product compliance data from your supply chain.
Streamline RoHS Compliance
Learn more about how Assent deep-maps your supply chain to streamline RoHS compliance.
Simplify SCIP Requirements
Meet your SCIP obligations and other related requirements. See how Assent can make SCIP submissions more simple.
Automate TSCA Compliance
Grow better with Assent’s product compliance platform, automating your TSCA program.
Industry Solutions for Complex Manufacturing
Discover how our automated supply chain sustainability management solutions help complex manufacturers see deeper, be smarter, and grow better.
Electronic Industry Solution
Find solutions to deep-map your electronics supply chain. Learn more about Assent’s platform and how we support your business growth goals.
Industrial Equipment Solution
Assent helps industrial equipment manufacturers grow better by allowing you to see deep into your supply chain.
See Deeper, Be Smarter, Grow Better
See why our supply chain sustainability platform is the number one choice for the world’s most sustainable complex manufacturers looking to solve EU Medical Device Regulation compliance.