CE Marked Class I Medical Device – Regulatory Compliance 

Regulatory Classification

The Orthocomfort Fully Adjustable Orthodontic Face Mask is classified as:



Class I Medical Device

In accordance with:

Regulation (EU) 2017/745 on Medical Devices (MDR)

As a Class I device, conformity assessment is conducted under manufacturer responsibility, supported by complete technical documentation and compliance procedures.

CE Marking & Declaration of Conformity

Orthocomfort devices are CE Marked following internal conformity assessment procedures in compliance with MDR requirements.

The following documentation is maintained and available upon request:

• EU Declaration of Conformity
• Technical Documentation File
• Risk Management Documentation
• Device Labeling Compliance Review



CE marking confirms that the device meets applicable safety and regulatory standards within the European Union.

Manufacturer Registration

Orthocomfort is registered with:

Spanish Agency of Medicines and Medical Devices (AEMPS) as a medical device manufacturer.

Registration ensures regulatory oversight and traceability within the Spanish and European medical device framework.

Technical Documentation & Traceability

Orthocomfort maintains structured documentation in accordance with MDR requirements, including:

• Device description and specifications
• Intended use documentation
• Risk analysis
• Manufacturing controls
• Labeling verification
• Post-market surveillance procedures



Each device is manufactured under traceability protocols ensuring production consistency and regulatory transparency.

Post-Market Surveillance

In accordance with MDR requirements for Class I medical devices, Orthocomfort implements post-market surveillance procedures to monitor product performance and maintain compliance.

This includes:

• Feedback monitoring
• Incident reporting procedures
• Documentation updates when required

Regulatory Transparency for Distribution Partners

Orthocomfort provides regulatory documentation to qualified distributors for:

• Product registration in local markets (where applicable)
• Regulatory review
• Due diligence processes

All documentation requests are handled directly through our compliance team.

Request Regulatory Documentation

Contact our compliance team for further information.

Orthodontic Face Mask Manufacturer

Fully Adjustable Facemask

Orthodontic OEM Manufacturer