CEPROCON.COM • BLOG ARTICLE • WEEK 10
What every construction product manufacturer needs to prepare, organise and maintain. This article is a practical guide to the technical file for CE marking construction products.
CE marking a construction product generates paperwork — and quite a lot of it. Test reports, product specifications, declarations, factory records, Notified Body certificates: over the course of a CE marking project, manufacturers accumulate a significant body of documentation. The technical file is where all of that comes together.
Yet despite its importance, the technical file is one of the least well understood aspects of CE marking. Many manufacturers treat it as an afterthought — assembling documents only when an audit or a customer request forces the issue. Others are uncertain what the file should contain, how it should be structured, or how long it must be kept.
This article provides a practical, comprehensive guide to building a technical file that is not just compliant, but genuinely useful as a working document throughout the life of your CE marked product.
What is the technical file?
The technical file is the complete set of documentation that supports a manufacturer’s Declaration of Performance (DoP) and CE marking. It is the evidence base — the collection of documents that demonstrates that the manufacturer has correctly followed the CE marking process and that the declared performance is genuine and verifiable.
The Construction Products Regulation (CPR) does not prescribe a single, rigid format for the technical file. What it requires is that the manufacturer holds documentation sufficient to demonstrate conformity with the applicable harmonised standard or European Assessment Document, and that this documentation is available to market surveillance authorities on request.
The technical file is not submitted to any authority as a matter of course — it sits with the manufacturer. But if a market surveillance authority requests it, it must be produced promptly and in good order. A missing, incomplete, or disorganised technical file in that situation is a serious compliance problem.
The core documents every technical file needs
While the specific content varies by product and harmonised standard, every technical file for a CE marked construction product should contain the following categories of documentation:
1. Product description and identification
A clear description of the product type — what it is, what it is made of, how it is constructed, and what it is intended to do. This includes dimensional specifications, material specifications, component descriptions, and any product variants covered by the same DoP. The product description must be precise enough that someone reading it could identify whether a specific physical product is or is not within scope.
2. The applicable harmonised standard or EAD
A copy of — or reference to — the harmonised standard (hEN) or European Assessment Document (EAD) under which the product is CE marked, including the specific version used. This provides the technical baseline against which all assessments are conducted. Where the standard has been revised since the original assessment, the file should record how the transition was managed.
3. Scope determination record
Documentation of the reasoning behind the scope determination — why this standard applies to this product, which intended uses are covered, and any scope boundaries that were considered. This is particularly important where the scope clause required interpretation, or where the product sits at the edge of a standard’s scope. A well-documented scope determination protects the manufacturer if the decision is ever questioned.
4. Type testing documentation
The test reports for all essential characteristics that were assessed by type testing. Each report should clearly identify the test standard used, the test method, the samples tested, the conditions, and the result. Where testing was carried out by an accredited or Notified Testing Laboratory, the laboratory’s accreditation details should be included. Raw data and calibration records for in-house testing should also be retained.
5. Calculations and design documentation
For products where performance is established by calculation rather than physical testing — such as some structural products assessed using Eurocodes — the calculations, design assumptions, and supporting data must be included. The methodology must be traceable and verifiable.
6. Notified Body documentation
Where a Notified Body was involved — under AVCP systems 1+, 1, 2+, or 3 — the relevant documentation issued by the Notified Body must be included. This means the Certificate of Constancy of Performance (systems 1+ and 1), the Certificate of Conformity of the FPC (system 2+), or the Notified Body test report (system 3). The Notified Body’s four-digit identification number must be consistent between this documentation, the DoP, and the CE marking label.
For products CE marked via the EAD/ETA route, the file should also contain the European Technical Assessment itself, along with documentation of the Technical Assessment Body (TAB) involvement. Note that the TAB and any subsequently involved Notified Body are distinct entities — both sets of documentation belong in the file.
7. Factory Production Control documentation
The FPC system documentation — written procedures, inspection records, test records, calibration records, non-conformance logs, and corrective action records — is a core part of the technical file. Under all AVCP systems the manufacturer must operate an FPC system, and under systems 1+, 1, and 2+ the Notified Body will audit it. The file should contain the current FPC manual or procedure set, plus records demonstrating that the system is being operated in practice.
8. The Declaration of Performance
The current version of the DoP — and all previous versions — must be retained in the technical file. Previous versions matter because they establish the declared performance at specific points in time, which is relevant if a product liability question arises relating to products placed on the market before the current DoP was issued. For a full explanation of what the DoP must contain and why it matters, see our article on The Declaration of Performance (DoP): what it is and why it matters.
9. CE marking label and accompanying information
A record of the CE marking label as affixed — including all the required accompanying information specified in Annex ZA.3 of the harmonised standard. Where the CE marking appears on packaging or accompanying documents rather than on the product itself, examples of those should be retained.
10. Instructions for use and safety information
Where the harmonised standard or applicable regulations require instructions for use to accompany the product, copies of those instructions in all required languages should be included in the technical file.
How to organise the technical file
There is no mandated structure for a technical file, but a logical, consistent organisation makes it far easier to use — both internally and in a market surveillance situation. A practical structure that works well for most construction products is:
| Section | Contents |
|---|---|
| Section 1 — Product overview | Product description, specifications, variants, intended use(s) |
| Section 2 — Regulatory basis | Applicable harmonised standard or EAD, scope determination record, AVCP system determination |
| Section 3 — Type testing | All test reports, laboratory accreditation details, raw data (where held) |
| Section 4 — Notified Body documentation | Certificate(s) or test reports from Notified Body; ETA and TAB documentation where applicable |
| Section 5 — Factory Production Control | FPC manual/procedures, inspection and test records, calibration records, non-conformance and corrective action records |
| Section 6 — Declaration of Performance | Current DoP and all superseded versions with effective dates |
| Section 7 — CE marking | CE label records, Annex ZA.3 accompanying information, instructions for use |
| Section 8 — Change log | Record of any changes to the product, standard, or documentation, with dates and descriptions |
Whether the file is maintained in physical form, electronically, or both is a matter for the manufacturer to decide. Electronic files are generally easier to manage, update, and retrieve — but whatever system is used, version control is essential. Every document in the file should be clearly identified with its version number and date.
How long must the technical file be kept?
The CPR requires manufacturers to keep the technical documentation and the DoP available for ten years after the last unit of the product has been placed on the market. This is a long retention period — and it runs from the last unit placed on the market, not from the date CE marking was first obtained.
For a product that is manufactured and sold continuously, this means the technical file must be maintained indefinitely while the product is on the market, plus ten years after it is discontinued. The practical implication is that document management — keeping records organised, accessible, and backed up — is not a one-off task but an ongoing responsibility.
When the technical file needs to be updated
The technical file is a living document, not a one-time submission. It must be reviewed and updated whenever:
- The product is modified in a way that could affect its performance against any essential characteristic
- The applicable harmonised standard is revised and the new version becomes mandatory
- New test results are obtained — whether through routine FPC testing, repeat type testing, or Notified Body surveillance
- The Notified Body issues a revised or renewed certificate
- The DoP is revised for any reason
- The CE marking label or accompanying information changes
Each update should be logged in the change record (Section 8 in the structure above), with a clear description of what changed, why, and when. This creates a traceable history of the product’s compliance status over time.
The most common technical file mistakes
Missing test reports. Test reports are obtained, the DoP is drawn up, and the CE mark is affixed — but the original test reports are never formally filed. Years later, when a customer or authority requests the file, the reports cannot be located. Always file test reports immediately and confirm they are in the technical file before the CE mark goes on the product.
Outdated DoP versions retained without version control. Multiple versions of a DoP exist across shared drives, email attachments, and printed copies, with no clear record of which is current. This creates real legal uncertainty about what was declared and when. Implement version control from day one — every DoP should have a version number, a date, and a clear status (current or superseded).
FPC records not maintained in practice. The FPC manual is well written and the Notified Body approved it — but in day-to-day production the records are not being completed consistently. FPC records that exist only on paper, but do not reflect what actually happens in the factory, are worse than useless: they create a false picture of compliance that will not survive scrutiny.
No change management process. The product is modified — a new raw material supplier, a formulation change, a dimensional adjustment — but the technical file is not reviewed and the DoP is not updated. This is one of the most common and most serious compliance failures. Every product change should trigger a formal review of whether the technical file and DoP need updating.
Treating the file as a one-time project. The technical file is built, CE marking is obtained, and the file is then left untouched. Standards are revised, certificates lapse, test methods are updated — and the file silently goes out of date. Technical file maintenance should be a scheduled, recurring activity, not something that only happens in response to a problem.
Summary
The technical file is the documentary foundation of CE marking for construction products. It brings together everything that supports the Declaration of Performance — the product description, the standard, the test results, the Notified Body documentation, the FPC records, and the DoP itself — into a coherent, organised, and retrievable body of evidence.
Building a good technical file from the start of a CE marking project takes planning and discipline. Maintaining it over the life of the product takes consistent process. But the alternative — an incomplete, disorganised file that fails under scrutiny — is a compliance and commercial risk that no manufacturer should be willing to accept.
For a broader view of how the technical file fits into the overall compliance journey, see our step-by-step overview of the CE marking process for construction products.
Need help building or reviewing your technical file?
Ceprocon helps manufacturers build compliant, well-organised technical files for CE marking under the CPR — from the initial scope determination through to DoP preparation and FPC documentation. We also cover technical file requirements in depth in our professional training programme.
contact@ceprocon.com • ceprocon.com
