For the EU type examination according to Directive 2014/34/EU (Module B) Annex III, an informal application for EU type examination must be submitted to FSA GmbH together with the technical documentation. The technical documentation must be adequate to assess the conformity of the product with the requirements of Directive 2014/34/EU. The following information and documents are required:

• The name and address of the manufacturer and, if the application is submitted by the authorized representative, also his/her name and address.
• A written declaration that the same application has not been submitted to any other notified body.
• A general description of the product including information on intended use and limits of application.
• The operating instructions according to Annex II No. 1.0.6 of Directive 2014/34/EU.
• Drafts, manufacturing drawings and plans of components, assemblies, circuits, etc.
• Descriptions and explanations necessary to understand the mentioned drawings and diagrams and the operation of the product.
• An appropriate risk analysis and assessment.
• A list of which harmonized European standards have been applied in full or in part. If harmonized standards are not applied, a description must be given of how the essential health and safety requirements set out in Annex II of the Directive are met and what other relevant technical specifications are applied. If harmonized standards are applied in part, the relevant parts must be indicated.
• Representative test samples. The notified body may request additional samples if necessary to carry out the test program.

The EU type examination is treated confidentially. However, FSA GmbH is obliged to publish issued EU type examination certificates.

You can download a compilation of the required documentation here.

Due to the BREXIT we can unfortunately no longer offer the above services for products destined for the British market. In the UK, UKCA certification is required.

If an additional application is made for the assessment of the QM system "Production" (Directive 2014/34/EU, Annex IV), further documents must be submitted:

• All relevant information about the intended product category
• Documents about the QM system
• Technical documentation of the approved type and a copy of the
• EU type examination certificate

Deposit of documents:

• For "non-electrical" category 2 equipment, an internal production control is carried out by the manufacturer in accordance with Annex VIII of Directive 2014/34/EU.
• According to Article 13 (1) (b), the internal production control documentation must be deposited with a notified body until 10 years after the last product has been delivered.
• As a rule, the documents are not reviewed by FSA GmbH and can therefore also be submitted closed or sealed.
• After written acknowledgment of the deposit by FSA GmbH, the manufacturer can issue the declaration of conformity and affix the CE mark.

The technical documents (documentation) must contain the following:

• A general description of the type with information on the intended use and description of the limits of use.
• Operating instructions in accordance with the requirements of Directive 2014/34/EU, Annex II, point 1.0.6.
• Designs, manufacturing drawings and diagrams of components, assembly subassemblies, circuits, etc. (assembly drawing, group drawings and as far as relevant individual part drawings).
• List of standards applied in part or in full and a description of the solutions chosen to meet the essential requirements where the standards have not been applied.
• if applicable, results of design calculations, tests, etc.
• if applicable, test results

A fee is charged for the deposit of documents:
The fee for archiving technical documents is calculated per year and folder.

All prices quoted are net plus VAT.