EU Medical Device Documentation
Class I medical device under MDR (EU) 2017/745.
Green Drain GD-MD, the medical-line device, follows the Class I conformity assessment route under Article 52(7) MDR. The four public regulatory documents, version 2.0 issued 14 September 2026, are available below.
- Class IRisk Classification
- EUDAMEDRegistered
- ISO 13485Manufacturing QMS
- 27EU Member States
Region scope
The classification on this page applies to the European Union only. Green Drain Europe ApS holds the EU Declaration of Conformity and Technical Documentation; the device is registered in EUDAMED under SRN DK-MF-000052289.
In the United States, Green Drain is not yet regulated as a medical device. US plumbing-code certifications (cUPC / ASSE 1072), food-equipment certifications (NSF/ANSI 2), and food-safety certification (HACCP International) are listed on the Certifications page.
Public regulatory documents.
Four regulatory documents are made publicly available to support transparency for EU specifiers and stakeholders. Additional Annex II Technical Documentation is held by the manufacturer and provided to competent authorities on request.
EU Declaration of Conformity
The manufacturer's signed declaration that Green Drain GD-MD conforms to the applicable provisions of MDR (EU) 2017/745. Identifies all ten device variants by UDI-DI and confirms compliance with Annex I General Safety and Performance Requirements. The primary regulatory document distributors and competent authorities request first.
Instructions for Use (IFU)
User-facing document covering device identification, intended purpose, intended users and environments, installation, warnings and limitations, maintenance, removal, disposal, materials, and traceability. Required under MDR Annex I, Section 23. The complete UDI-DI table for all ten variants is included.
Technical Summary
A public-facing overview derived from the Annex II Technical Documentation. Covers device overview, functional principle, key characteristics, verification and performance, materials, manufacturing and quality systems, and regulatory status. Designed for technical specifiers including architects, engineers, and infection prevention consultants.
Regulatory Summary
Plain-language explanation of the regulatory position: classification rationale, conformity assessment route, compliance framework, EUDAMED registration, and explicit scope and limitations. The document to share with non-technical stakeholders evaluating regulatory standing.
What MDR Class I means for EU specifiers.
Green Drain's MDR classification reflects how the device is used in healthcare and built-environment hygiene programs. The classification confirms regulatory standing without changing what the device does or how it's installed.
Regulatory scope
Green Drain's intended use is as a supportive measure within infection prevention and control frameworks, specifically through the reduction of environmental exposure pathways associated with floor drain systems. That intended use places it within the scope of MDR (EU) 2017/745.
Why Class I
The device is non-invasive, non-sterile, contains no measuring function and no software, and does not have direct or indirect contact with the human body. Under Annex VIII classification rules, this places it in Class I, the lowest risk class under MDR.
Self-certification under Article 52(7)
Class I devices that are non-sterile and non-measuring follow the self-certification pathway. The manufacturer holds full Annex II Technical Documentation, a Risk Management File aligned with ISO 14971, and a GSPR checklist demonstrating compliance with Annex I. Competent authorities may audit this file at any time.
Manufacturing under ISO 13485
MDR Article 10(9) requires every manufacturer to run a quality management system. For Class I devices it does not have to be certified, but Green Drain manufacturing is certified to ISO 13485:2016 in addition to ISO 9001:2015. This includes batch-level traceability, change control, and corrective and preventive action processes.
Scope and limitations.
Green Drain GD-MD is a passive environmental control device. Its regulatory classification confirms what the device does, and equally what it does not do. The boundaries are stated explicitly in the IFU and Regulatory Summary.
The device does
- Function as a one-way mechanical barrier in floor drains
- Restrict the upward movement of air and aerosols from drainage systems
- Support hygiene and infection prevention and control programs
- Reduce environmental exposure pathways associated with floor drains
The device does NOT
- Prevent, diagnose, treat, or cure disease
- Make claims about reduction of infection rates or patient outcomes
- Replace established hygiene protocols or cleaning procedures
- Have direct or indirect contact with the human body
Unique Device Identification (UDI-DI).
Each variant carries a distinct UDI-DI registered in the European database EUDAMED. The Basic UDI-DI groups all ten variants under a single product family identifier.
Basic UDI-DI
5745001471GreenDrainMDRJD
Need additional documentation for your EU project?
Annex II Technical Documentation, GSPR checklists, Risk Management File excerpts, and other technical files are available to competent authorities and qualified specifiers on request.