Table of Contents

Introduction

Navigating EU MDR compliance can feel like stepping into a regulatory maze—especially for startups and consultants handling Class I medical devices. The European Union Medical Device Regulation (EU MDR) tightened the rules in recent years, and many founders underestimate what’s actually required for a “low-risk” product.

This FAQ breaks down the most common compliance questions for Class I medical devices under EU MDR compliance. It’s designed to give you practical, no-fluff answers in plain English. Whether you’re a medical device startup founder, legal advisor, or regulatory consultant, this guide will help you avoid delays, penalties, or product recalls.

Let’s start with the basics and build up to the common pitfalls and strategic insights.

Q1: What exactly qualifies as a Class I medical device under EU MDR?

A Class I medical device is one that presents low risk to users and patients. Examples include bandages, wheelchairs, stethoscopes, and reusable surgical instruments. These devices must still meet strict safety and performance requirements under EU MDR compliance 2017/745.

Key point: Risk classification isn’t based on your opinion or marketing—it’s determined by Annex VIII of the regulation, which considers invasiveness, duration of use, and body contact.

Tip: Always use the official EU MDR compliance medical classification rules and seek professional advice to avoid misclassification.

Q2: Do I still need CE marking for a Class I device?

Yes. Even Class I devices must have a CE mark before entering the EU market. However, most Class I devices can be “self-certified,” which means the manufacturer can affix the CE mark without going through a Notified Body.

Exception: If your Class I device is sterile, has a measuring function, or is reusable surgical equipment, a Notified Body must be involved.

Action: Complete your technical documentation and create a Declaration of Conformity (DoC) before applying the CE mark.

Q3: What documentation is required for Class I devices?

Here’s what you need for compliance:

Technical documentation (Annex II & III MDR)
Declaration of Conformity
Product labeling and instructions for use
Risk management file (ISO 14971)
Post-market surveillance plan
Clinical evaluation report

Even for low-risk devices, the documentation must show that your product meets General Safety and Performance Requirements (GSPR) in Annex I.

Tip: Don’t wait until the end to compile this—start documentation during product development.

Q4: Do I need a Quality Management System (QMS)?

Yes, a QMS is mandatory under Article 10(9) of EU MDR Compliance, even for Class I devices.

It doesn’t have to be ISO 13485 certified, but your QMS must cover:

Complaint handling
Post-market surveillance
Traceability
Design and development
Production control

Mistake to avoid: Using only ISO 9001—it doesn’t meet EU MDR Compliance-specific requirements.

Q5: What are Post-Market Surveillance (PMS) and Vigilance?

PMS refers to monitoring your device’s performance after it’s on the market. You must collect user feedback, analyze complaints, and take corrective actions where needed.

Vigilance refers to serious incidents and field safety corrective actions (FSCA) that must be reported to the competent authority.

Deliverables required:

PMS Plan (Annex III)
PMS Report or PSUR (depending on class)
Trend reporting

Key tip: For Class I devices, you only need a PMS Report—not a full Periodic Safety Update Report (PSUR).

Q6: What if I outsource manufacturing?

If you’re the legal manufacturer under MDR—even if someone else produces the device—you are responsible for EU MDR compliance.

You’ll need:

A signed agreement with the subcontractor
Clear QMS control over outsourced processes
Ability to trace each batch and demonstrate conformity

Common mistake: Thinking the supplier holds the liability. They don’t—you do.

Q7: How does Brexit affect Class I compliance in the UK vs EU?

Post-Brexit, the UK has its own regulations under the MHRA. If you want to sell in both regions:

For the EU, you need CE marking under EU MDR Compliance.
For the UK, you need to register with MHRA and may need a UK Responsible Person.

Extra step: Appoint an Authorized Representative in the EU if you’re not based there.

Takeaway: You may need dual documentation, dual representation, and slightly different labeling.

Q8: What if I want to sell online or through Amazon?

Amazon and other platforms now require proof of EU MDR compliance. They may ask for:

CE Certificate
Declaration of Conformity
Manufacturer’s details and labeling

Without this EU MDR compliance, your product could be delisted or blocked in EU markets.

Checklist for selling online:

Upload CE documents in seller portals
Ensure packaging and IFUs meet MDR labeling
Include Authorized Representative info if needed

Bonus Tip: Don’t Ignore Language Requirements

All documents—especially labeling and instructions for use—must be translated into the official language(s) of the countries where the product is sold.

Mistake: Launching with English-only documentation in countries like France or Germany.

Fix: Use certified medical translators and review national competent authority guidelines.

Closing Thoughts + Call-to-Action

Complying with EU MDR Compliance for Class I devices isn’t as simple as it sounds. While you don’t need a Notified Body in most cases, you still face documentation, surveillance, and liability obligations. This FAQ should give you a reliable roadmap to start—but don’t try to do it all from memory.

📩 Still have questions? Book a consultation with our legal and regulatory compliance team.

📄 Want a quick guide? Download our Class I Device EU MDR Compliance Checklist now.

EU MDR Compliance FAQ for Class I Medical Devices