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 meets every applicable provision of MDR (EU) 2017/745. Issued 20 April 2026 by Green Drain Europe ApS, signed by the Person Responsible for Regulatory Compliance, identifying all eight device variants by UDI-DI.
Region scope: This Declaration of Conformity applies to the European Union only. In the United States, Green Drain is not currently classified as a medical device. US plumbing-code certifications are listed on the Certifications page.
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.
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, 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, 20 April 2026
Authorised signatory
Keld Rindom, Managing Director and Person Responsible for Regulatory Compliance (PRRC)
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 device that was sterile, measuring, or in body contact would fall under a higher class with corresponding Notified Body involvement.
The Declaration of Conformity covers all eight Green Drain variants. Each variant has its own UDI-DI registered in the European database EUDAMED, sharing the Basic UDI-DI listed above.
The signed Declaration of Conformity, issued 20 April 2026 by Green Drain Europe ApS. Three pages, public, available for distribution to importers, distributors, specifiers, and competent authorities.
Required user-facing document under MDR Annex I, Section 23. Covers identification, intended purpose, installation, warnings, maintenance, and traceability for all 8 device variants.
Public-facing extract of the Annex II Technical Documentation. Device overview, functional principle, materials, manufacturing, and standards references.
Plain-language explanation of the regulatory position: classification, why MDR applies, conformity route, EUDAMED registration, and explicit scope and limitations.
Distributors, specifiers, and competent authorities can request additional Annex II Technical Documentation, GSPR checklist excerpts, or specification language tailored to a project.