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.
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Assent has helped hundreds of companies. We’re proud to work with the following organizations.
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.
Learn more about recent enforcement actions that demonstrate why proactive compliance is a business must.
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.
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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.
Industry Solutions for Complex Manufacturing
Discover how our automated supply chain sustainability management solutions help complex manufacturers see deeper, be smarter, and grow better.
EU Medical Device Regulation Resources
Browse related education, regulatory information, and expert-led webinars from our resource library and blog.
The EU MDR Deadline and What Happens Now
Medical device companies doing business in the European Union (EU) may have circled May 26, 2021, in red on their calendars — but any company treating the dea …
Why EU MDR Compliance Is Important for Global Manufacturers
For manufacturers, missing supplier information is the main cause of lost sales and product recalls. Medical device companies will face increased risk when the …
The Regulatory Landscape for Medical Devices
Due to their impact on human life, medical devices are highly regulated. Not only that, but the list of products in scope of medical device regulations continue …
