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.

See Deeper With Assent’s EU MDR Solution

Assent’s EU MDR solution allows manufacturers to deep-map the complex manufacturing ecosystem, unlocking the ability to survey suppliers at the part level for substances of very high concern (SVHC) data, gain deep visibility into supply chain risk, and support IPC-1752A Class D XML imports.

Ensure Business Continuity

Protect your market access and ensure you meet your EU MDR requirements by seeing deep into your supply chain to examine suppliers, their products, and even substances within parts.

Maintain Brand Loyalty

To maintain brand reputation and protect against recalls, you need to ensure your products are trustworthy and safe. Assent will collect the hard data you need to get there, going down to the root of what’s material in your products.

Maximize Resources

Reassign internal resources from data collection to revenue-boosting activities, ensuring you meet your business goals.

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.