EU Declaration of Conformity
The manufacturer's signed declaration of conformity with MDR (EU) 2017/745.
The EU Declaration of Conformity is the legally required document under Article 19 of the Medical Device Regulation. It is the manufacturer's formal, signed statement that Green Drain GD-MD meets every applicable provision of MDR (EU) 2017/745. Version 2.0, issued 14 September 2026 by Green Drain Europe ApS and signed by the Person Responsible for Regulatory Compliance, identifying all ten device variants by UDI-DI. It supersedes the declaration issued 20 April 2026.
Region scope: This Declaration of Conformity applies to the European Union only. In the United States, Green Drain is not yet regulated as a medical device. US plumbing-code certifications are listed on the Certifications page.
What the EU Declaration of Conformity is.
Under the EU Medical Device Regulation, every medical device sold in the European Economic Area must be supported by a Declaration of Conformity (DoC) before it can be placed on the market. The DoC is the manufacturer's legally binding statement that the device meets the General Safety and Performance Requirements set out in Annex I of the Regulation, and that the appropriate conformity assessment procedure has been carried out.
For a Class I device that is non-sterile, non-measuring, and not a reusable surgical instrument, the conformity assessment route is set out in Article 52(7). The manufacturer carries out the assessment under sole responsibility, compiles the Annex II Technical Documentation, applies the CE marking, and signs the Declaration of Conformity. No Notified Body is required for this class.
The DoC is what distributors, importers, and competent authorities request first. It is what specifiers reference when verifying that a product is legally placed on the EU market. It is the document that makes the rest of the regulatory file actionable.
Key facts on the document.
Manufacturer
Green Drain Europe ApS
Birk Centerpark 40, DK-7400 Herning, Denmark
Single Registration Number (SRN)
DK-MF-000052289
Trade name and device type
Green Drain GD-MD, waterless drain trap seal
Basic UDI-DI
5745001471GreenDrainMDRJD
Risk classification
Class I per Annex VIII of MDR (EU) 2017/745
Conformity assessment
Article 52(7), self-declared under sole responsibility
Place and date of issue
Herning, 14 September 2026
Authorised signatory
Keld Rindom, Managing Director and Person Responsible for Regulatory Compliance (PRRC)
Document version
v2.0, status Public. Supersedes the declaration issued 20 April 2026.
Intended purpose, as stated in the Declaration.
The intended purpose is the legally bounded description of what the device is for. It defines what claims may be made and what claims may not. The text below is reproduced verbatim from the Declaration of Conformity.
Green Drain is a passive mechanical device intended for installation in floor drains. It functions as a one-way barrier allowing fluid passage while restricting the upward movement of air and aerosols from drainage systems.
The device is intended to support hygiene and infection prevention and control measures by reducing potential environmental exposure pathways.
The device does not have a direct medical, therapeutic, or diagnostic effect on the human body. EU Declaration of Conformity, Section 3 (Intended Purpose)
How conformity is demonstrated.
Compliance with the General Safety and Performance Requirements (GSPR) of Annex I is demonstrated through a structured set of documents that the manufacturer maintains and makes available to competent authorities on request.
Annex II Technical Documentation
The complete Technical Documentation file required under MDR Annex II. Includes device description, design and manufacturing information, GSPR checklist, benefit-risk analysis, and post-market surveillance plan. Held by the manufacturer; made available to competent authorities on request.
GSPR Checklist (Annex I)
Item-by-item documentation of how each applicable General Safety and Performance Requirement is met. Annex I covers requirements on device safety, performance characteristics, materials, infection and microbial contamination, devices incorporating substances, devices interacting with the environment, and information supplied with the device.
Risk Management File (ISO 14971)
Aligned with the international standard for risk management of medical devices. Documents identified hazards, estimated and evaluated risks, risk control measures, and residual risk acceptability. Updated through the device lifecycle as part of post-market surveillance.
Verification and Validation Documentation
Engineering test data demonstrating that the device meets specifications and intended purpose. Includes laboratory testing of functional performance under controlled flow conditions, mechanical integrity, dimensional conformity, packaging and transport resilience, and aerosol containment under controlled testing.
Standards and quality systems referenced.
The Declaration of Conformity references the following standards and quality systems that support the demonstration of conformity. These are independent of MDR but reinforce the regulatory file with internationally recognised benchmarks.
ASSE 1072: Drain Trap Seal Devices
The American Society of Sanitary Engineering performance standard for barrier-type floor drain trap seal protection devices. Green Drain holds an IAPMO cUPC listing under this standard. View the cUPC ASSE 1072-2020 page for the full North American certification details.
WMTS 522: WaterMark Technical Specification
The Australian plumbing standard for waterless trap seal devices. Green Drain is WaterMark certified under this specification. View the WaterMark certification page for license details.
ETA-18/0536: European Technical Assessment
The European Technical Assessment for Green Drain, issued by ETA-Danmark A/S under EAD 180020-00-0704 for waterless odour traps. Validates performance characteristics under the Construction Products Regulation, separate from but cross-referenced by the MDR file. View the CE / ETA-18/0536 page.
ISO 9001:2015 and ISO 13485:2016
Quality Management Systems standards. ISO 9001:2015 is the general QMS standard; ISO 13485:2016 is the medical-device-specific QMS standard. Although Class I devices do not require ISO 13485 certification, Green Drain manufacturing operates under both. This includes batch-level traceability, change control, and corrective and preventive action processes.
Device profile, as declared.
Section 8 of the Declaration of Conformity records specific characteristics of the device that determine the applicable regulatory pathway.
Each of these attributes is what places the device in Class I under Annex VIII of MDR. A sterile or measuring version would still be Class I, but a Notified Body would have to assess its sterility or measuring function (Article 52(7)). A different intended purpose, such as contact with injured skin, could place it in a higher class.
Device variants identified by UDI-DI.
The Declaration of Conformity covers all ten Green Drain GD-MD variants. Each variant has its own UDI-DI registered in the European database EUDAMED, sharing the Basic UDI-DI listed above.
EU Declaration of Conformity
The signed Declaration of Conformity, version 2.0, issued 14 September 2026 by Green Drain Europe ApS. Three pages, public, available for distribution to importers, distributors, specifiers, and competent authorities.
- Manufacturer identification and SRN
- Basic UDI-DI plus all ten variant UDI-DIs
- Verbatim intended purpose statement
- Risk classification and conformity assessment route
- Standards and quality systems referenced
- Authorised signatory details
Need verification or technical support for an EU project?
Distributors, specifiers, and competent authorities can request additional Annex II Technical Documentation, GSPR checklist excerpts, or specification language tailored to a project.