A 1990s installation without CE — legal, but not unconditionally
2026-07-18 · Medpipe technical team
In brief. An installation built in accordance with the regulations in force on the day of its construction remains legal — the CE marking requirement does not apply retroactively. The boundary is intervention: an extension or refurbishment creates a new scope, which is subject to the requirements of Regulation MDR (EU) 2017/745 and to testing according to the standard PN-EN ISO 7396-1:2016-07. What a historical installation lacks is not the marking but the evidence — substitute documentation reconstructs what can be documented.
Many Polish hospitals operate today on pipelines built before anyone required the CE mark. That is not a legal defect — until the moment someone reaches for a wrench.
Is an installation built before the CE era illegal?
No. A medical gas installation built in accordance with the regulations in force on the day it was carried out remains legal, and the CE marking requirement does not apply retroactively. Legacy installation without CE marking so it does not have to disappear from the hospital merely because it lacks a nameplate.
The protection, however, applies to the existing state. The law protects what was built then — not what someone adds tomorrow.
The real gap is not the marking, but the evidence
The biggest problem with old pipelines is not the lack of a certificate, but the lack of proof that the installation is what it claims to be. The binders vanished during the third reorganisation, the contractor has long ceased to exist, and the as-built diagram lives solely in the memory of a maintenance technician who retires in a year.
The effect is very practical: no one can say in advance exactly what a given area valve shuts off. An inspection, an audit and a failure all ask exactly the same question — and none of them accepts the answer "it has always been like that".
What can be reconstructed as substitute documentation?
Substitute documentation is a set of evidence produced today that replaces papers which can no longer be recovered. Surprisingly much can be reconstructed — provided it is done methodically and not as a side task during an inspection.
- Installation inventory on site: the actual routes, diameters, terminal units and the real coverage of the zone valves.
- Test and trial results confirming the current parameters and the tightness of the system.
- A compiled history of repairs, replacements and alterations — including those never documented.
- Unambiguous definition of the system boundaries: what is the device and what is the building installation.
The scope, the sequence and the required form of these activities are set out in the guide „Medical gases in practice. Volume 1" (GMWP) developed by INMED S.A.
When does an extension stop being servicing?
An extension stops being servicing the moment it changes the intended purpose, the design capacity or the system boundaries. Replacing a damaged component with an equivalent one is maintenance; a new wing, new terminal units or a different supply source is a regulatory event.
Then a dilemma modernisation versus a new medical device ceases to be academic. Art. 16 MDR assigns the manufacturer's obligations to whoever substantially modifies a device already placed on the market — not necessarily to whoever built it once. An invoice described as „installation works" offers no protection against that classification. GMWP shows where this boundary runs and what happens once it is crossed.
Frequently asked questions
Does an old installation have to be replaced because it has no CE marking?
No. The mere absence of CE marking on an installation predating the requirement is not in itself grounds for replacing it. Action is determined by the technical condition and the ability to demonstrate the parameters, not by the construction date.
Is an as-built survey enough to replace the original documentation?
An as-built survey is the foundation of substitute documentation, but on its own it is not enough. Without tests confirming the parameters and without defined system boundaries it remains a drawing, not evidence.
Who is responsible for the installation after an extension?
Liability rests with whoever made the substantial change — to the extent that they introduced it. That is why the nature of the works is worth settling on paper before anyone cuts the first pipe.
The legal status of installations predating the CE obligation, the actual scope of substitute documentation and the threshold beyond which an extension creates a new device are described in more detail in Zeszyt 1 — order the GMWP guide.
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.