Class I Medical Device Self-Certification Under EU MDR

Class I Medical Device Self-Certification Under EU MDR: A Step-by-Step Guide for Manufacturers #

If you manufacture or sell medical devices in the European market, understanding the European Medical Device Regulation (EU MDR) is essential. Class I medical devices, being the lowest risk category, have fewer regulatory hurdles compared to higher classes—but that doesn’t mean compliance is simple. This guide walks you through the Class I self-certification process and helps determine whether you are considered a manufacturer under the EU MDR.

Table of Contents

1. Are You a Medical Device Manufacturer Under EU MDR?
2. Class I Medical Device Self-Certification: Your Compliance Roadmap
3. Common Questions from Medical Device Manufacturers
4. Why Work with a V-REG SOLUTIONS?

Class I Medical Device Self-Certification Under EU MDR: A Step-by-Step Guide for Manufacturers #

If you manufacture or sell medical devices in the European market, understanding the European Medical Device Regulation (EU MDR) is essential. Class I medical devices, being the lowest risk category, have fewer regulatory hurdles compared to higher classes—but that doesn’t mean compliance is simple. This guide walks you through the Class I self-certification process and helps determine whether you are considered a manufacturer under the EU MDR.

Table of Contents

1. Are You a Medical Device Manufacturer Under EU MDR?
2. Class I Medical Device Self-Certification: Your Compliance Roadmap
3. Common Questions from Medical Device Manufacturers
4. Why Work with a V-REG SOLUTIONS?

Are You a Medical Device Manufacturer Under EU MDR? #

Many businesses assume they are just sellers or distributors when, in reality, they fall under the definition of a manufacturer. Here’s how to determine if you are a manufacturer under the EU MDR:

✔️ Do you place a medical device on the market under your name or trademark? If yes, you are a manufacturer, even if another company designs or physically produces the device. #

✔️ Do you repackage, relabel, or modify a device before selling it? If you make changes that affect the device’s intended use, safety, or performance, you are considered a manufacturer. #

✔️ Do you take responsibility for compliance with MDR? If you ensure regulatory conformity, create documentation, and CE-mark a product, you are the legal manufacturer. #

If you answered “yes” to any of these questions, you must comply with the EU MDR requirements for medical device manufacturers.

Class I Medical Device Self-Certification: Your Compliance Roadmap #

Unlike higher-risk medical devices, most Class I devices [excluding sterile (Is), reusable (Ir), or have a measuring function (Im)] do not require a Notified Body. Instead, manufacturers can self-certify by following these key steps:

1. Confirm Your Device Classification #

Misclassification can lead to non-compliance and market withdrawal. Your device must align with the EU MDR classification rules (Annex VIII). If you’re unsure, consulting a regulatory expert can help.

2. Prepare Technical Documentation #

To meet the General Safety and Performance Requirements (GSPR) outlined in Annex I of the EU MDR, manufacturers must prepare and maintain:

• Device description, specification, and classification rationale
• Instructions for use and sample labelling
• GSPR Checklist, in relation to Annex I of EU 2017/745 or EU 2017/746 as applicable
• Applicable standards list
• Risk Management File, containing the Risk Management Plan and Risk Management Report, in conformity with EN ISO 14971
• Validation and Verification: Test Reports, when and where applicable, for example:
  1. Biological Evaluation to ISO 10993 series
  2. 60601 series testing
  3. Sterilization Validation report
  4. Any other relevant data
• Clinical Evaluation Report, in conformity with MEDDEV 2.7/1 rev.4, MDCG 2020-13
• Post-Market Surveillance Plan or Protocol
• Declaration of Conformity
• Your ISO 13485 QMS certificate or evidence that you have a QMS in accordance with Article 10 (9) of the regulations

Appoint an Authorized Representative #

If you are a manufacturer based outside the EU, you must appoint an Authorized Representative (AR). The AR acts as your official point of contact within the EU and ensures compliance with MDR requirements. Their responsibilities include:

• Ensuring your device meets all regulatory requirements
• Holding copies of technical documentation
• Communicating with EU regulatory authorities on your behalf
• Being listed on your product labelling for transparency

Implement a Quality Management System (QMS) #

While ISO 13485 certification is not mandatory for Class I manufacturers, having a QMS that aligns with MDR requirements ensures product consistency, traceability, and regulatory compliance.

Draft a Declaration of Conformity #

This is your legal statement confirming that your device complies with the EU MDR. Once completed, you are responsible for placing the CE mark on your product.

Register Your Company & Device #

All medical device manufacturers must register in the European Database on Medical Devices (EUDAMED) and obtain a Single Registration Number (SRN). In some EU countries, additional national registrations may be required.

Maintain Compliance & Post-Market Surveillance #

EU MDR compliance doesn’t end after certification. You must continuously monitor product performance, report incidents, and update documentation as necessary.

Common Questions from Medical Device Manufacturers #

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Do all Class I devices qualify for self-certification? No. Class I devices that are sterile (Is), reusable (Ir), or have a measuring function (Im) require Notified Body involvement.

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What happens if I misclassify my device? You risk regulatory penalties, product recalls, and losing market access. It’s best to seek expert guidance if you’re uncertain.

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Is a Quality Management System mandatory for Class I devices? Yes, but it doesn’t have to be ISO 13485 certified. However, a well-documented QMS helps ensure compliance and efficiency.

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How do I keep up with MDR updates? Subscribe to EU regulatory updates, join industry forums, and consult regulatory experts regularly.

Why Work with a V-REG SOLUTIONS? #

EU MDR compliance can be complex, and non-compliance can be costly. Working with an expert ensures:

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Proper classification and documentation.

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Faster market entry with fewer regulatory roadblocks

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Ongoing compliance with MDR updates

At VReg SOLUTIONS, we specialize in regulatory consulting for medical devices, helping manufacturers navigate EU MDR with confidence. Whether you need guidance on classification, technical documentation, or post-market compliance, we’re here to support you.

📞 Contact us today to ensure your Class I device is compliant and market-ready!

By following this roadmap, Class I medical device manufacturers can successfully navigate the self-certification process and ensure compliance with EU MDR requirement.