Construction acceptance does not release the installation for clinical use
2026-05-02 · Medpipe technical team
In brief. Construction acceptance confirms conformity with the design and the construction regulations — it does not release a medical gas installation for clinical use. Clinical release requires acceptance and testing according to the standard PN-EN ISO 7396-1:2016-07 and documentation of the medical device compliant with the requirements of Regulation MDR (EU) 2017/745. These are two independent legal regimes and two different final documents.
The acceptance report signed, the inspector satisfied, the investment settled — and the installation still may not be used on a patient. This is not an official's mistake, but two different legal regimes meeting on one construction site.
Why does construction acceptance not release the installation for clinical use?
Construction acceptance confirms that the building was executed in line with the design and technical building regulations — it does not confirm that the installation is a medical device released for clinical use. These are two independent regimes measuring entirely different things.
Topic medical gas installation and construction law looks like routine plumbing work. The real stake is different: at the other end of the pipe is the patient's breath, not domestic hot water. Construction law asks about the building. Medical device law asks about the intended purpose and the clinical safety of the system.
What exactly do the designer's sanitary-installation qualifications cover?
Designer's sanitary engineering licence entitle the holder to design installations within the meaning of construction law — and nothing beyond that. They do not make anyone a manufacturer of a medical device, nor do they replace conformity assessment.
Therefore medical device design is a separate document, created under a different regime and evidenced by different means. A signature on the discipline design does not transfer that responsibility. The drawing may be flawless and the system will still remain formally not released for use.
Where do the boundaries of responsibility run on a hospital construction site?
Limits of responsibility defines not the scope of the contract, but who is formally responsible for the device put into use. Within a single facility, a consistent separation must be made between:
- the role of the sanitary systems designer and the role of the pipeline system manufacturer,
- construction documentation and medical device documentation,
- acceptance of the works and release of the system for clinical use,
- the provisions of the contract with the contractor and the scope of the declaration of conformity.
These pairs get confused precisely because they concern the same pipe in the same wall. The consequences only come to light at handover of the facility — or during an inspection.
Why does the problem start in the contracting authority's documentation?
If the client's documentation describes construction works only, then at the end of the project no one is responsible for the medical device. That gap cannot be repaired with an acceptance report — it had to be anticipated when the subject matter of the contract was described.
The systematic separation of the two regimes is described in the guide „Medical gases in practice. Volume 1" (GMWP) developed by INMED S.A. There you will find the logic behind the division of roles and documents, as well as the points at which projects most often get stuck.
Frequently asked questions
Does an occupancy permit mean that the installation may be connected to a patient?
No. An occupancy permit concerns the building structure, not the release of the medical gas system for clinical use. That is a separate path and a separate set of evidence.
Can a sanitary systems designer be responsible for a medical device?
Not by virtue of construction licences alone. Liability for the device arises under a different regime and requires deliberate assignment in the tender and contract documentation.
When at the latest must the two regimes be separated?
Before the procurement procedure is announced. At the acceptance stage only costly corrections remain — which the GMWP states outright.
Do you want to put the division of roles, documents and acceptances in order on your own project? Order the GMWP guide and go through both legal regimes step by step.
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.