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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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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.

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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.


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.

Supplier Management

Automate queries to suppliers when new substances come in scope of the EU MDR, and minimize supplier fatigue by streamlining duplicate data collection.

Detailed Reporting

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.

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Why Assent

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.

Discover Our Approach

Assent’s Complete EU MDR Solution

Assent’s platform provides medical device manufacturers with data transparency, data security, program management, and supplier support. Learn more about how Assent provides the missing foundation complex manufacturers need to reveal hidden risks and opportunities.

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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.