Technical documentation, also referred to as a technical file, is mandatory for most products that require CE marking in the European Union. As such, technical documentation is mandatory for electronics, toys, protective equipment, medical devices, machinery, and more.
However, understanding what to include in your technical documentation, and how to actually go about creating it, can be challenging.
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What is technical documentation?
Technical documentation is a set of product and compliance-related documents. The required documents vary depending on the product and regulation. Here is a general overview:
- Product design drawings
- Product photos
- Bill of materials
- Source code
- Product label files
- Packaging files
- User instructions
- List of applicable directives/regulations/standards
- Test reports
- Risk assessment
Most importers and manufacturers already have many of these documents as part of their product specifications, although not necessarily organized as technical documentation for compliance purposes.
Example: Technical documentation for toy
- Toy design and functionality description
- Technical drawing
- Component/materials list
- CE mark and traceability label files
- Packaging artwork files
- EN 71 test reports
- REACH test reports
- Declaration of Conformity copy
- User instructions copy
- Risk assessment
How do I know which documents to include?
The exact items needed in your technical documentation depend on what is written in the applicable directives and regulations. There can also be differences between conformity assessment procedures.
Example: Low Voltage Directive (Annex III)
(a) a general description of the electrical equipment;
(b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
(c) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the electrical equipment;
(d) a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union or international or national standards referred to in Articles 13 and 14 […]
(e) results of design calculations made, examinations carried out, etc.; and
(f) test reports.
Example: Toy Safety Directive (Annex IV)
(a) a detailed description of the design and manufacture, including a list of components and materials used in the toy as well as the safety data sheets on chemicals used, to be obtained from the chemical suppliers;
(b) the safety assessment(s) carried out in accordance with Article 18;
(c) a description of the conformity assessment procedure followed;
(d) a copy of the EC declaration of conformity;
(e) the addresses of the places of manufacture and storage;
(f) copies of documents that the manufacturer has submitted to a notified body, if involved;
(g) test reports and description of the means whereby the manufacturer ensured conformity of production with the harmonised standards, if the manufacturer followed the internal production control procedure referred to in Article 19(2); and
(h) a copy of the EC-type examination certificate, a description of the means whereby the manufacturer ensured conformity of the production with the product type as described in the EC-type examination certificate, and copies of the documents that the manufacturer submitted to the notified body, if the manufacturer submitted the toy to EC-type examination and followed the conformity to type procedure referred to in Article 19(3).
Which EU regulations and directives require technical documentation?
In general, directives and regulations that include CE marking provisions also require technical documentation. Here are some examples of such directives and regulations:
- Toy Safety Directive
- Low Voltage Directive
- EMC Directive
- RoHS Directive
- Radio Equipment Directive
- Battery Regulation
- Ecodesign Directive
- Medical Devices Regulation
- Personal Protective Equipment Regulation
- Machinery regulation
While not related to CE marking, the new General Product Safety Regulation (GPSR) also includes provisions that refer to technical documentation.
Which products require technical documentation?
There is not a definitive list of products that require technical documentation. This depends entirely on the applicable directives and regulations. Generally speaking though, it can be said that the following products must have technical documentation:
- Consumer electronics
- Protective equipment
- Medical devices
Notice that these are only examples and not an exhaustive list.
How do I create technical documentation?
Technical documentation is created by the importer or manufacturer of a product. The technical documentation is not ‘obtained’ from a government body or testing company.
For context, here are some of the actions taken when creating technical documentation:
1. Create product design files
2. Create a bill of materials
3. Create packaging artwork
4. Create product label files
5. Write user instructions
6. Book lab testing and obtain test reports
7. Assess applicable regulations and directives
8. Draft the Declaration of Conformity
Chances are that you most likely already have most documents required to create technical documentation as it is largely based on standard product documents.
Who is responsible for creating technical documentation?
The creation of technical documentation is often referred to as a manufacturer obligation.
Example: Toy Safety Directive (Article 4)
Manufacturers shall draw up the required technical documentation in accordance with Article 21 and carry out or have carried out the applicable conformity assessment procedure in accordance with Article 19.
However, keep in mind that a manufacturer is not necessarily the factory owner but the company which owns the brand or has created the design.
As such, if you find a factory on Alibaba which manufactures your products according to your design or with your brand – then you are the manufacturer.
Do importers need to create technical documentation?
Importers are required to “obtain” the technical documentation.
Example: Toy Safety Directive (Article 6)
They shall ensure that the manufacturer has drawn up the technical documentation, that the toy bears the required conformity marking and is accompanied by the required documents, and that the manufacturer has complied with the requirements set out in Article 4(5) and (6).
However, it is extremely unlikely that you can find a supplier outside the EU that just so happens to have a complete set of technical documentation. Even if they do, it is even less likely that they will be willing to share sensitive technical drawings, source code, and other valuable IPs.
What this means is that importers often have to create their own technical documentation, even if this is not specified in the directive or regulation.
Can I obtain technical documentation from my supplier?
As mentioned, it is very unlikely that a supplier outside the EU maintains a complete set of technical documentation, that they also happen to be willing to share.
Further, if you are manufacturing custom-designed products you are the legal manufacturer and it is entirely up to you to create the technical documentation.
The non-EU companies that have technical documentation are generally large multinationals like Apple, Nintendo and Xiaomi – not small factories making custom-designed and private-label products listed on Alibaba.
As such, the creation of technical documentation essentially always falls on the importer or manufacturer in the EU.
What can happen if I don’t have technical documentation?
Failing to provide technical documentation can result in fines and a forced recall. That said, it’s actually quite rare that national market surveillance authorities in the EU request technical documentation. What they primarily look at is the Declaration of Conformity (DoC) and the corresponding test report.
There are two reasons for this:
Complexity: It’s easier to assess compliance based on a quick DoC and test report review, compared to making that same assessment on the technical documentation. Ultimately, they can also send your product for compliance testing. I imagine that a few importers failing a DoC and test report check would have a set of technical documentation that holds up.
IP protection: Documents requested by government authorities can go into the public domain, meaning that the technical documentation becomes publically available. Few businesses want their product design drawings and BoM out there for the world to see. National market surveillance authorities in the EU understand this.
Do we need to submit the technical documentation?
There are three scenarios in which you need to submit the technical documentation:
A: In case your product must be certified by a Notified Body.
B: In case of a request from national market surveillance authorities.
C: Submit to an authorised representative.
That being said, most manufacturers and importers in the EU never submit their technical documentation.
Where should the technical documentation be stored?
Many businesses maintain a digital set of technical documentation and printed copies as backup.
Do I need one set of technical documentation for each product?
Yes, you normally need to create a set of technical documentation per product you place on the market. Mixing technical documents for more than one product would normally not make any sense.
Do I need technical documentation to sell on Amazon?
Amazon’s compliance team normally require the following documents when checking compliance:
- Declaration of Conformity (DoC)
- Test report
- Product photos (CE mark)
I am not aware of any case in which Amazon has requested technical documentation. I assume this is also for the same reason that most market surveillance authorities in the EU primarily check the DoC and test reports.
If an importer or manufacturer can’t get the DoC and test report right, their chances of having a correct technical file are slim.