What qualifies a product to be labeled “Made in USA”?

To make an unqualified “Made in America” claim, a product must be “all or virtually all” made in the United States. This means final assembly occurs in the U.S., and nearly all materials, parts, and processing are of domestic origin. If significant imported content is involved, companies should use a qualified claim (e.g., “Assembled in the USA with imported parts”).

Why are “Made in America” claims facing increased enforcement?

Enforcement is increasing due to a 2026 executive order directing the FTC to prioritize action against deceptive U.S.-origin claims. Combined with existing rules that allow civil penalties, companies making unsupported claims face greater scrutiny, financial penalties, and reputational risk.

How can companies ensure their U.S.-origin claims are compliant?

Companies should treat country of origin claims as a compliance process by collecting and validating supply chain data, documenting sourcing and manufacturing details, and aligning marketing language with evidence. Claims should be reviewed across all channels — including labels, websites, and marketplaces — to ensure consistency and accuracy.

What changed in the 2026 EU Deforestation Regulation (EUDR) update?

The EU Council adopted revisions that postpone the application of the EU Deforestation Regulation (EUDR) while introducing simplification measures. Large and medium operators must comply by December 30, 2026, and small and micro operators have until June 2027. A new category of “downstream operator” was introduced, and certain small or micro primary operators may submit a simplified declaration instead of a full due diligence statement (DDS). These changes provide additional preparation time but do not reduce the regulation’s core due diligence and traceability requirements.

What are companies required to do under EUDR by 2026?

Companies placing in-scope products on the EU market must demonstrate that their goods are deforestation-free as of December 31, 2020; produced in accordance with the relevant legislation of the country of production; and covered by a DDS. This requires tracing commodities to the exact geolocation of the plot of land, conducting a risk assessment, mitigating identified deforestation risks, and maintaining auditable supply chain documentation. Commodities in scope include cattle, cocoa, coffee, palm oil, rubber, soya, and wood, along with many derived products.

What are the risks of non-compliance with EUDR?

Non-compliance penalties are determined by EU member states and may include fines of up to 4% of total annual EU turnover, confiscation of goods or revenues, temporary exclusion from public procurement, and public naming of non-compliant companies. Beyond financial penalties, the most immediate risk is loss of EU market access. Without a valid Due Diligence Statement, in-scope products cannot legally be placed on the EU market.

How should companies use the 2026 delay strategically?

The postponement to 2026 should be viewed as a strategic preparation window, not a pause. Companies should use this time to improve supplier engagement, close data gaps in traceability, implement structured risk assessment processes, centralize supply chain data management, and evaluate EUDR compliance software. Building traceability and defensible due diligence processes now will also strengthen readiness for related EU sustainability requirements.

Solutions
Product Compliance
EU Medical Device Regulation Solution

AI-Powered EU MDR Compliance Software for Medical Device Manufacturers

Reduce your risk, protect your EU market access, and increase your program’s productivity under the European Medical Device Regulation (EU MDR) with Assent’s secure MDR software.

Book a Demo Start Product Tour

Heart monitoring screen on generic medical device

Jump to a section

Challenge
Compliance Management
Your Bottom Line
Featured Resource
Solution
Case Studies
Other Solutions
Expert Resources
Get Started

Avoid Costly Recalls & Legal Risks With Superior MDR Data

Source Materials With Confidence

Assent’s team of experts ensures your program is up to date with the latest EU MDR requirements, and helps educate your suppliers.

Book a Demo

Data-Driven Decisions

Proactive Risk Identification

Reduce Supplier Fatigue

How Assent MDR Software Streamlines EU MDR Compliance

AI-Enhanced Data Management

Automate collection of EU MDR declarations and supply chain data for topics like substances of very high concern (SVHC) and per- and polyfluoroalkyl substances (PFAS).

A Single Platform for Medical Device Compliance

The Assent Sustainability Platform gives medical device manufacturers and their suppliers a centralized and intuitive space to rapidly share compliance data and EU MDR declarations.

Easier, Faster Compliance Reporting

Assent makes it easy to roll up medical device supply chain data to generate submissions to the European Database on Medical Devices (EUDAMED).

FAQ: EU Medical Device Regulation

This FAQ outlines what the EU Medical Device Regulation covers and how Assent’s AI-native software helps manufacturers manage compliance efficiently and accurately.

What is MDR in medical device compliance?

The Medical Device Regulation (MDR) is the European Union’s framework for ensuring the safety, quality, and traceability of all medical devices sold in the EU. It replaced the older Medical Device Directive (MDD) and expanded compliance obligations for manufacturers, including reporting on materials and suppliers. Achieving EU MDR compliance requires clear, accurate data about every part and substance in your device supply chain.

How is EU MDR different from the MDD?

The new EU Medical Device Regulation strengthens product oversight and patient safety compared to the former MDD. It expands which products are in scope, adds strict substance reporting rules under Section 10.4, and increases accountability through the European Database for Medical Devices (EUDAMED). In short: more data, more transparency, and higher expectations for manufacturers. Using tools like AI-native MDR software helps organizations keep up with these evolving standards.

What substances and materials are covered under the EU Medical Device Regulation?

The EU MDR expands reporting requirements to include substances that are carcinogenic, mutagenic, or toxic to reproduction (CMR), as well as those with endocrine-disrupting (ED) properties. Any material containing these substances above a 0.1% weight by weight threshold must be disclosed and justified under Section 10.4 of the regulation. Manufacturers also need to track updates to related frameworks like REACH and RoHS, since new substances are frequently added.

How does Assent help manufacturers meet EU MDR compliance requirements?

Assent’s AI-native MDR software simplifies complex compliance workflows by collecting, validating, and centralizing supplier data across your medical device supply chain. The platform automatically updates your technical files when new substances are added to MDR or REACH lists, reducing manual work and audit risk. With built-in dashboards and automated supplier engagement, manufacturers can maintain continuous medical device compliance and protect EU market access with confidence.

Case Studies

Medical Device Compliance at Scale With Assent

Argon Medical Devices needed support to collect and validate substance-level data for 60,000 parts from 630+ suppliers. By implementing Assent’s comprehensive platform, Argon was able to generate accurate compliance reports in 80% less time.

Christopher Mix

Manager of Corporate Compliance, Argon Medical Devices

Read Case Study View All Case Studies

Ryerson joined forces with Assent in 2020 to overhaul their compliance processes. Using Assent for product compliance, including TSCA PFAS, streamlined their operations and drove cost savings equivalent to 20 full-time salaries. The company has seen a 50% improvement in supplier outreach campaign completion time and accuracy, as well as a reduction in resources needed to achieve compliance.

Andrea Okun

Deputy General Counsel & Chief Compliance Officer, Ryerson

Read Case Study View All Case Studies

Explore Other Solutions with Assent

SOLUTION

Simplify SCIP Requirements

See Solution

SOLUTION

Streamline RoHS Compliance

See Solution

SOLUTION

Automate TSCA Compliance

See Solution

SOLUTION

PFAS Reporting

See Solution

Optimize your supply chain with industry-specific solutions.

Book a Demo

Book a Live Demo

Get Started With Our Complete EU MDR Platform

See how Assent helps you simplify EU MDR compliance with a secure AI-native platform that automates supplier data collection, streamlines data analysis, and generates defensible compliance records.

First Name*

Last Name*

Business Email*

Company*

Phone

Job Title*

Comments

AI-Powered EU MDR Compliance Software for Medical Device Manufacturers