Plain-language explanation of Green Drain's EU MDR regulatory position.

Regulatory classification.

Reproduced verbatim from the Regulatory Summary.

Green Drain is classified as a Class I medical device under Regulation (EU) 2017/745 (Medical Device Regulation, MDR).

The device is non-sterile, non-measuring, non-invasive, and self-certified by the manufacturer. No Notified Body involvement is required. Regulatory Summary, Regulatory Classification

Why MDR applies to a drain device.

Green Drain is a passive mechanical device intended for use in built environments, including healthcare settings. The device does not act directly on the human body and has no therapeutic or diagnostic function. Its role is limited to environmental control within the scope of its intended purpose.

MDR applicability is based on the device's intended use as a supportive measure within infection prevention and control frameworks, specifically through the reduction of environmental exposure pathways associated with floor drain systems. Under MDR, the regulator does not assess the device by what it physically is. The regulator assesses what the device is intended for, in what setting, and how the manufacturer states it should be used. When that intended use plugs into a healthcare hygiene framework, the device falls within MDR scope.

This is the same logic that brings sterile single-use bandages, exam gloves, manual stethoscopes, and walking aids under MDR. None of those devices treat disease either. Each is regulated as a medical device because the manufacturer states that the device is for use within a healthcare context and is therefore subject to general safety and performance requirements.

Why Class I is the appropriate class.

Annex VIII of MDR sets out the classification rules. The class assigned to a device depends on its duration of use, invasiveness, body system contact, and intended purpose. Class I is the lowest risk class. Class IIa, IIb, and III escalate progressively to higher risk.

Green Drain qualifies for Class I because it is not invasive, not sterile, contains no measuring function, contains no software, and has no direct or indirect contact with the human body. The classification reflects the simplicity of the device and the indirect nature of its contribution to hygiene. A device that was sterile or in body contact would fall under a higher class with corresponding Notified Body involvement.

How conformity is assessed.

Conformity has been established under Article 52(7) of MDR (EU) 2017/745. The manufacturer declares conformity under sole responsibility. This is the prescribed conformity assessment route for Class I devices that are non-sterile, non-measuring, and not reusable surgical instruments.

Self-certification is not the absence of oversight. Under Article 52(7), the manufacturer must:

• Compile and maintain Annex II Technical Documentation
• Demonstrate compliance with the General Safety and Performance Requirements (Annex I)
• Implement risk management aligned with ISO 14971 principles
• Apply the CE marking and issue a signed Declaration of Conformity
• Carry out post-market surveillance through the device lifecycle
• Make all of the above available to competent authorities on request

Competent authorities in each EU member state retain audit rights. The Danish Medicines Agency (Lægemiddelstyrelsen) is the relevant authority for Green Drain Europe ApS. The manufacturer must respond to authority requests for documentation and must report serious incidents and field safety corrective actions through the EUDAMED system.

Device identification and EUDAMED registration.

Green Drain is registered within EUDAMED, the European database on medical devices. EUDAMED is the EU-wide registry where manufacturers, devices, and incidents are recorded. Some EUDAMED modules are publicly accessible, allowing distributors and procurement teams to verify a manufacturer's registration and a device's UDI-DI.

A distributor or buyer can search EUDAMED using the manufacturer SRN to confirm legal placement on the EU market. Each variant UDI-DI provides traceability at the device level.

Manufacturing and quality management.

Green Drain manufacturing operates under both ISO 9001:2015 (general QMS) and ISO 13485:2016 (medical-device-specific QMS). ISO 13485 is not a regulatory requirement for Class I devices; the manufacturer holds it voluntarily. Manufacturing processes include batch-level traceability, quality control and inspection, change control, and corrective and preventive action procedures.

Frequently asked regulatory questions.

Is self-certification under Article 52(7) less rigorous than Notified Body certification?

It is a different pathway, not a less rigorous one. The same General Safety and Performance Requirements apply. The manufacturer compiles the same Technical Documentation. Risk management follows the same standard. The difference is who reviews the file before placement on market: for Class I non-sterile devices, the manufacturer signs and is accountable; for Class IIa, IIb, and III, a Notified Body audits before market entry. In both cases, competent authorities retain ongoing audit rights.

How is this different from the EU's previous Medical Devices Directive?

MDR (EU) 2017/745 entered into force on 26 May 2021, replacing the previous Medical Devices Directive (93/42/EEC). MDR strengthens requirements around technical documentation, post-market surveillance, traceability through UDI, and EUDAMED registration. Green Drain's classification was established under MDR.

What is a Person Responsible for Regulatory Compliance (PRRC)?

Article 15 of MDR requires every manufacturer to designate a PRRC, an individual with specified qualifications who is the named person accountable for regulatory matters. The PRRC verifies device conformity, post-market surveillance, vigilance reporting, and technical documentation. For Green Drain Europe ApS, the PRRC is Keld Rindom, who also serves as Managing Director.

Does this apply outside the EU?

The MDR classification applies to the European Union and, through mutual recognition arrangements, to the European Economic Area (Iceland, Liechtenstein, Norway). Switzerland and the United Kingdom each operate parallel medical device frameworks. The United States has not classified Green Drain as a medical device. Other regions are governed by their own national regulators.

Where can I verify EUDAMED registration?

EUDAMED is accessible at ec.europa.eu/tools/eudamed. Public access varies by module; some manufacturer and device data is searchable using the SRN or UDI-DI. The ongoing rollout of EUDAMED modules is published by the European Commission.

What if a Class IIa or higher classification was needed in the future?

If the device's intended purpose, design, or contact characteristics change in a way that triggers a higher classification, the manufacturer would need to engage a Notified Body, expand the technical documentation, and re-certify. Class assignment is intended-use-specific.

Related documents and certifications.