EU MDR Class I for hospital equipment — what it means for procurement

EU Regulation 2017/745 (the Medical Device Regulation) came into force on 26 May 2021. Classification by risk determines which documents are mandatory and which conformity assessment route applies. Class I covers non-invasive devices with the lowest level of risk — including certain types of sanitary and environmental equipment used in healthcare facilities.

Classification under Annex VIII

MDR Annex VIII defines four risk classes (I, IIa, IIb, III) on the basis of:

• Duration of contact with the body (transient, short-term, long-term)
• Invasiveness (non-invasive, invasive, surgically invasive, implantable)
• Whether the device is active or passive
• Specific characteristics (measuring function, sterilisation, delivery of energy)

Rule 1 (the base rule for non-invasive devices): a non-invasive device that does not come into contact with the body is Class I. That is where Green Drain™ sits — a physical barrier inside the drain, with no patient contact, no active components and no sterilising function.

What Class I means in practice

Class I is self-certification. The manufacturer issues an EU Declaration of Conformity, registers the device in the EUDAMED database and runs post-market surveillance. No Notified Body involvement is required for the base class — unless the device has a measuring function, is supplied sterile or is intended for reuse.

That does not mean 'less regulated'. The technical file still has to cover:

1. A description of the device and its intended purpose
2. Identification of the applicable ISO/EN standards
3. Risk assessment to ISO 14971
4. Clinical evaluation (CER)
5. A quality management system (ISO 13485 recommended)
6. A post-market surveillance system
7. A vigilance system (incident reporting)

What Class I does not mean

In tenders, medical device status is sometimes read as a guarantee of outcome. It is not. Class I does not mean the device:

• Prevents, diagnoses or treats disease
• Guarantees a reduction in healthcare-associated infection rates
• Replaces hand hygiene, environmental cleaning or the existing IPC bundle
• Comes into direct or indirect contact with the patient

It does mean that the manufacturer has declared conformity with the MDR essential requirements and carries the liability for that declaration, that the device is registered in EUDAMED with a Basic UDI-DI and the manufacturer's SRN, that it is made under a quality management system aligned with ISO 13485:2016, and that a documented post-market surveillance plan exists.

The distinction matters when the technical specification is drafted. What is being specified is a documented barrier between the ward environment and the drain biofilm, not a device that lowers incidence on its own.

The difference between CE marking and MDR Class I

The two are frequently confused. A CE mark can indicate conformity with any number of different directives (construction products, low voltage, EMC and so on). CE + MDR specifically identifies a medical device. The distinction matters for:

• Which procurement channel applies in healthcare (medical versus technical)
• Eligibility for funding earmarked for medical equipment
• Its standing in IPC documentation (a valid infection control measure)
• How it is labelled in the CMMS (medical equipment, not an accessory)

What to ask for in the tender file

When a Class I device is bought for a hospital or a health centre, the file submitted through the Croatian public procurement portal (EOJN) should contain:

1. The EU Declaration of Conformity (DoC). Signed by the legal manufacturer or the EU Authorised Representative. It names the device, the UDI-DI and the harmonised standards applied.
2. Evidence of EUDAMED registration. Basic UDI-DI, the manufacturer's SRN and the device identifier. For Green Drain™ the SRN is DK-MF-000052289.
3. The ISO 13485 certificate. In date, issued by an accredited certification body, in the name of the manufacturer — not the distributor.
4. Instructions for Use (IFU). In Croatian, because the device is being made available on the Croatian market.
5. A technical documentation summary. Intended purpose, materials, performance evidence, biocompatibility evaluation and risk analysis.
6. A post-market surveillance plan. How the manufacturer collects complaints, vigilance signals and field experience.

If this is set as a condition of suitability, word it so that it can be checked: 'the product is registered in EUDAMED as a Class I medical device under Regulation (EU) 2017/745, SRN to be supplied'. EUDAMED is a public database, so the claim can be verified before the contract is signed.

ISO 13485 and the fit with the IPC programme

ISO 13485:2016 is the quality management standard for medical device manufacture. For a passive drain seal the elements that matter are lot traceability back to the production batch, controlled sourcing of medical-grade silicone, documented change control with risk assessment, complaint handling that feeds post-market surveillance, and CAPA root-cause analysis of failures.

A Class I seal does not replace existing infection control measures. It adds a documented, regulated barrier between the room and the drain biofilm — an exposure route described in the literature on hospital drains as a source of infection. In practice the IPC team adds the drain inventory and the barrier status to the built-environment risk assessment, procurement files the MDR documents alongside other medical device records, and the estates team logs every seal installed.

Croatian specifics

The Croatian Agency for Medicinal Products and Medical Devices (HALMED) is the competent authority for MDR devices. Foreign CE-MDR devices with a complete file do not require additional registration with HALMED, but the distributor must have a representative established in Croatia and a working vigilance system.

Green Flow d.o.o. (Zagreb) is the exclusive distributor of Green Drain™ for the Adria region, with a local vigilance contact point and the complete MDR file available for audit.