CE marking · Gap analysis
Is your product already on the market, or do you want to know where its technical file stands? We visit you, examine the product and its documentation against the applicable legislation and standards, then give you a clear gap analysis: where you stand, what is missing and how to fix it.
Who it is for
Check an existing technical file against current legislation and standards.
Know where the project stands before starting testing or production.
Importer, distributor or acquirer wanting to know the actual status of a product.
Prepare a sound response to a request for documentation.
Our approach
An advisory audit: we do not just list the gaps, we tell you how to close them.
We come to see you, examine the product and its variants, its marking, its instructions and its manufacturing, and talk with your design and production teams.
What you receive
We establish the audit’s reference framework: EU and Swiss legislation, harmonised standards and current editions, including upcoming changes such as the Machinery Regulation or the Cyber Resilience Act.
What you receive
For each requirement, we compare what exists with what is expected: technical documentation, risk assessment, test reports, declaration of conformity, marking and instructions. Each gap is described and ranked by priority.
What you receive
We recommend how to close each gap: tests to complete, documents to draft, design corrections, priorities and timeline. We can then support you in implementing them.
What you receive
When to carry out an audit
Machinery Regulation from 20 January 2027, Cyber Resilience Act from 11 December 2027: is your product ready?
Regulations (EU) 2023/1230 and 2024/2847When a harmonised standard changes, the old edition eventually ceases to give a presumption of conformity.
New version, new component, new software: do tests need to be repeated or the technical file updated?
A market surveillance authority, distributor, customer or acquirer asking for the documentation.
Our approach
Your product, its situation and your objectives. 30 minutes.
You send us the existing technical file; we establish the reference framework.
Examination of the product and discussions with your teams, on site.
Gaps, priorities and action plan, presented to your teams.
Swiss market
In Switzerland, as in the EU, market surveillance authorities can request a product’s technical documentation and declaration of conformity. An audit tells you the actual status of your technical file, so you can respond with confidence, with an action plan if anything is missing.
Source: Swiss Product Safety Act (PrSG), SR 930.11.
Frequently asked questions
Does your product raise a specific question? Ask an engineer directly.
Book a callIt is an analysis of the gaps: for each requirement applicable to your product, we compare what exists, in the product and in the technical file, with what is expected. The result is a list of gaps ranked by priority, each with the way to close it.
Not necessarily. Conformity is assessed at the moment each individual unit is placed on the market: a product manufactured today must comply with today’s legislation and, to benefit from the presumption of conformity, with the current editions of the harmonised standards. An audit lets you take stock.
Sources: Blue Guide 2022, OJ C 247, 29.6.2022
No. The audit checks what exists and identifies what is missing: it specifies exactly which tests need to be completed, which we can then take care of.
A clear report: the reference framework applied, the table of requirements and their status, the gaps ranked by priority, and a practical action plan to close them. We present it to you and, if you wish, support you in implementing it.
Yes, anywhere in Switzerland. Seeing the product, its manufacturing and your teams makes for a far more accurate audit than simply reading documents. Part of the analysis can also be done remotely.
Book a call
Book a 30-minute slot with an engineer directly. No back-and-forth by email: you choose the time, we prepare the call.
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