CE marking · End-to-end support
CE marking shows that your product meets the EU requirements that apply to it. Säfeli takes care of everything: advice, risk assessment, laboratory testing, technical documentation and the EU declaration of conformity. You stay in control of your product; we manage its compliance.
The process
The path is the same for every product; what changes are the legislation, the standards and the tests. We handle each step with you.
Functions, intended use, users, environment and technologies: everything starts here.
SäfeliWe analyse your product with your teams.
EU directives and regulations, Swiss ordinances: a single product often falls under several of them.
SäfeliWe identify every piece of legislation that applies, today and tomorrow.
Harmonised standards and the state of the art, in the editions that give a presumption of conformity.
SäfeliWe select the standards and check their status in the Official Journal.
Hazards, hazardous situations and risk reduction measures, across the whole product life cycle.
SäfeliWe conduct the assessment with your design teams.
Design requirements, tests and verifications that demonstrate conformity.
SäfeliWe carry out the tests and verify every requirement.
Description, drawings, risk assessment, test reports, instructions: the evidence of conformity.
SäfeliWe compile the complete technical file.
The manufacturer signs the EU declaration of conformity and affixes the CE marking to the product.
SäfeliWe prepare the declaration and check the marking; you sign.
We take care of everything
One partner for every part of CE marking: fewer contacts, fewer back-and-forths, a consistent technical file.
Legislation, standards, conformity assessment procedure, notified body where required: we answer your questions and make the regulatory decisions with you, from the first call to placing on the market.
What you receive
Electrical safety, mechanical safety, EMC, radio, IP rating, batteries: we take care of the tests required and provide reports you can use directly in your technical file.
What you receive
Description, drawings, risk assessment, test reports, instructions, labelling: we compile the technical documentation and prepare the EU declaration of conformity for you to sign.
What you receive
A new edition of a standard, a product change, new legislation such as the Machinery Regulation or the Cyber Resilience Act: we keep your technical file up to date and alert you to what changes.
What you receive
CE marking
By affixing the CE marking, the manufacturer declares that the product meets all applicable requirements and takes responsibility for it. Only the manufacturer or its authorised representative may affix it.
Regulation (EC) No 765/2008, Article 30CE marking is not granted by a third party. A notified body is only involved where the legislation requires it, depending on the product and its category.
Decision No 768/2008/EC, Annex IIThe technical documentation and the declaration of conformity must be available for the market surveillance authorities, generally for 10 years.
Blue Guide 2022, OJ C 247, 29.6.2022Swiss market
In Switzerland, the Product Safety Act (PrSG) and the sector-specific ordinances adopt most EU requirements. Depending on the sector, CE marking is required, accepted or replaced by other obligations. For each product, we check what applies on both markets, so that you can sell in Switzerland and in the EU with a single technical file whenever possible.
Source: Swiss Product Safety Act (PrSG), SR 930.11.
Frequently asked questions
Preparing to place a product on the market? Talk directly to an engineer.
Book a callThe manufacturer, or its authorised representative established in the EU. By affixing it, the manufacturer declares that the product meets all applicable requirements and takes responsibility for it. An importer or distributor that places a product on the market under its own name becomes the manufacturer.
Sources: Regulation (EC) No 765/2008, Article 30; Blue Guide 2022
No. It is not a certificate issued by a third party, but the manufacturer’s declaration that the product conforms. For some products, the legislation also requires a notified body to be involved before the marking can be affixed.
Sources: Regulation (EC) No 765/2008, Article 30; Decision No 768/2008/EC
It depends on the product, its stage of development and the tests required. The certification plan gives a precise estimate of your project’s timeline and costs before you commit.
Keep the documentation, follow new editions of standards and new legislation, reassess the product after every change and respond to requests from the authorities. Conformity is assessed at the moment each individual unit is placed on the market: a product manufactured today must comply with today’s rules.
Sources: Blue Guide 2022
Switzerland adopts most EU requirements, and the Switzerland–EU Mutual Recognition Agreement (MRA) makes market access easier in many sectors. Depending on the product, CE marking is required, accepted or replaced by other obligations, as with toys. We check this for your product.
Sources: Swiss Product Safety Act (PrSG), SR 930.11
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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