"The installation has CE" — a sentence that confirms nothing
2026-03-29 · Medpipe technical team
In brief. The CE marking confirms the conformity of only the device for which it was issued — the boundaries are set by the scope of the notified body's certificate. A marked system does not arise automatically from a sum of marked components. Combining devices into a system is governed by Article 22 of Regulation MDR (EU) 2017/745. At acceptance, request the scope of the certificate, the EU declaration of conformity and the assembly document.
The CE marking is not a stamp on the entire installation — it is a declaration about a specific device, within a specific scope, made by a specific entity. Without the certificate scope, the EU declaration of conformity and the system assembly document, the hospital does not know who is responsible for what.
"The installation has CE." The sentence is uttered at acceptance, everyone nods, the report goes into the file. And at that very moment the hospital usually has no idea who is responsible for the conformity of what it has just accepted.
The CE marking is not a stamp on the whole. It is a declaration about a specific device, within a specific scope, made by a specific entity.
What does the CE marking on a medical gas installation prove?
The CE marking on a medical gas installation confirms the conformity of the device for which it was issued — and of nothing beyond it. The regulator has its own CE. The terminal unit has its own. The compressor has its own. The sum of marked components does not automatically produce a marked system.
That is why the question "does the installation have CE marking" is wrongly framed. The proper one reads: who declared it and for what scope.
The scope of the notified body's certificate decides everything
A certificate whose scope has not been read is decoration. The scope of a notified body certificate indicates which categories of devices and which activities the assessment covers — and just as clearly, what it does not cover.
A certificate number in a bid looks impressive. The annex defining its scope makes the difference.
The EU declaration of conformity names the responsible party
The EU declaration of conformity is the document in which the manufacturer takes responsibility for the device under its own name and at its own risk. Without it the certificate hangs in a vacuum: there is an assessment, but no signature under its consequences.
If no one issues such a document for the installation being accepted, the responsibility does not disappear. It shifts towards the facility.
Art. 22 MDR: putting devices together is a separate obligation
An installation comes into being by combining many separate devices, and art. 22 MDR treats the assembly of devices as an event with its own documentary consequences. It is not enough that each component individually was legally placed on the market.
Whoever assembles is the one who declares. Exactly where that boundary runs is broken down in detail in the guide „Medical gases in practice. Volume 1" (GMWP) developed by INMED S.A.
ISO 13485 and CE marking are two different things
ISO 13485 certifies the manufacturer's quality management system, not the conformity of a specific device. The relationship between ISO 13485 and CE marking is often blurred in tenders — one sounds like the other and looks equally serious on letterhead.
What to ask the contractor before acceptance
Five questions that usually reveal whether the documentation really exists or only in the tender description:
- Which entity acts as the manufacturer of the installation being accepted?
- What is the full scope of the certificate — with its annex, not the number alone?
- Has an EU declaration of conformity been issued and what exactly does it cover?
- How was the assembly of devices into a single system documented?
- Which items are covered by the marking and which are deliberately outside it?
The answers should be given before the protocol is signed. After acceptance they change status from a condition to a complaint.
Frequently asked questions
Is the CE marking of individual components sufficient for acceptance of the installation?
No. The marking of individual devices does not replace the documentation of the system created by combining them. These are two separate layers of responsibility.
Who is the manufacturer of a medical gas installation?
The entity that assembles the devices into a system and signs off on it with its own documentation — not necessarily the manufacturer of the most expensive item in the cost estimate. Establishing this before acceptance is cheaper than afterwards.
Does the contractor's ISO 13485 certificate confirm the conformity of the installation?
No. It attests to the supplier's quality system and is an indication of credibility, not proof of conformity of the device as accepted.
A practical development of the topic — how to read scopes and what should go into the installation file — can be found in the GMWP. Order the GMWP guide and check your installation's documentation before someone else does.
Prepared by: the technical team of Małgorzata Dopierała, Damian Czyczyro and Przemysław Kostera — Medpipe Sp. z o.o., design, audits and inspections of medical gas installations. This article is based on the guide „Gazy medyczne w praktyce. Zeszyt 1” (Medical Gases in Practice, GMWP), INMED S.A.