EU MDR Class I Medical Device
The EU MDR Class I Medical Device framework helps you demonstrate compliance with Regulation (EU) 2017/745 (MDR), ensuring your products meet regulatory and market requirements.
What EU MDR Class I Medical Device Covers
The Regulation (EU) 2017/745 (MDR) requires businesses operating in EU to demonstrate compliance through proper assets and reporting. Sustalium provides a structured compliance framework that guides you through every requirement, from initial assessment to final publication. Your compliance asset includes a public-facing certificate page with a unique URL and QR code, making it easy to share with buyers, regulators, and stakeholders. With Sustalium, you can create, manage, and update your compliance assets efficiently — no consultants required.
The Professional Choice for EU MDR Class I Medical Device
Manufacturers face a growing challenge: compliance assets that must be structured, verifiable, and always current — not scattered across PDFs, spreadsheets, and email chains.
Structured for this framework
Pre-built EU MDR Class I Medical Device template with all required fields, data structures, and output formats. Enter your data once — it maps to the framework automatically. No starting from scratch, no manual formatting, no compliance gaps.
What you get
Structured compliance framework for EU MDR Class I Medical Device, Public certificate page with QR code, Audit-ready PDF export — delivered as a verifiable public page with QR code, PDF export, and tiered access controls.
Covers your markets
EU — Sustalium's structured approach works across jurisdictions, so you don't rebuild for each market.
Generate your EU MDR Class I Medical Device compliance asset in minutes.
Applicable Markets
- EU: Mandatory under Regulation (EU) 2017/745 (MDR)
What's Included
- Compliance declaration and evidence pack
- Regulatory assets and reporting
- Audit-ready records and certificates
- Risk assessment and mitigation summary
- Stakeholder communication templates
- Versioned compliance history
Who It's For
Manufacturers, importers, distributors, and brand owners who need to demonstrate Medical Devices compliance for EU markets.
Frequently Asked Questions
What is EU MDR Class I Medical Device?
EU MDR Class I Medical Device is a compliance framework that Declaration of Conformity for Class I medical devices under EU MDR. Sustalium provides the structured framework so you do not have to start from scratch.
Who needs EU MDR Class I Medical Device?
EU MDR Class I Medical Device is relevant for Medical device manufacturers, Class I device makers, Healthcare suppliers. Any business in EU or selling to partners who require this declaration benefits from a published, verifiable compliance document.
How long does it take to publish a EU MDR Class I Medical Device?
Publishing your EU MDR Class I Medical Device takes ~1-2 hours. The data model is already structured — add your data, review, and publish. No research, no consultants, no starting from scratch.
What do I receive after publishing?
A public, verifiable compliance page with a unique URL and QR code. Share as a link, embed on your website, or export as a PDF. Public, audit-only, and internal access tiers let you control who sees what.
What happens when EU MDR Class I Medical Device regulations change?
Sustalium continuously updates every framework as regulations evolve. Your existing data carries forward — review and re-publish. No starting over, no missed deadlines.
Create Your EU MDR Class I Medical Device asset
Generate your EU MDR Class I Medical Device compliance asset in minutes.
From €10 per asset · No subscription · Published in minutes