All European CE-marking directives and regulations oblige the non-food product manufacturers to prepare technical documentation, also known as “Technical File”, before providing the final Declaration of Conformity. The technical documentation shall provide essential proof that a product fulfils the relevant product safety requirements.
This article provides a brief overview of what a technical file is and what it should contain. Special attention is given to the contents of the technical documentation for respiratory products (e.g. face masks) according to the PPE Regulation 2016/425.
What is a technical file?
The technical file represents a set of documents that demonstrate the conformity of a product with the CE-marking legislation. The documentation must specify the applicable product safety requirements and cover the design, manufacture, and operation of the product.
The technical file must be available for inspection by the national market surveillance authorities as soon as the product is placed on the European single market, whatever its geographical origin is. Sometimes, the documentation may also need to be submitted to a Notified Body for review.
Usually, the manufacturer or their authorised representative must keep the technical file for at least 10 years from the last date of manufacture of the product. However, some CE-marking directives provide for a different duration (e.g. 5 years according to the MDD 93/42/EEC).
What is the content of the technical documentation?
The contents of the technical documentation differ between the different CE-marking directives. However, as a rule, the documentation should include at least the following elements:
- A general description of the product.
- Conceptual product design and manufacturing drawings and, where appropriate, schemes of components, circuits, etc.
- Descriptions and explanations needed for the understanding of those drawings and schemes.
- A list of the harmonised and non-harmonised standards applied in full or in part during the conformity assessment process.
- Test reports and risk assessment file.
- Copies of conformity documentation for critical product components.
- Instructions for use.
- A copy of the Declaration of Conformity.
The exact details included in the technical file depend on the nature of the product and on what is considered as required for demonstrating the conformity of the product to the essential product safety requirements of the relevant directive(s).
The technical documentation for face masks according to the PPE 2016/425 must contain the following elements:
- General description of the product and scope of application.
- General requirements, such as design principles, comfort and effectiveness, design and fitting systems, etc.
- Conceptual product design and manufacturing drawings, and descriptions and explanations needed for the understanding of those drawings and schemes.
- A list of the harmonised standards applied in full or in part during the conformity assessment process.
- Risk assessment file and test reports.
- Mask marking and packaging information.
- Instructions for use.
- Photos of the product.
- A copy of the Declaration of Conformity.
- A copy of the EU type-examination certificate according to module B.
- Conformity documentation according to module C2.
What is the format of the technical file?
There are no legal requirements regarding the structure and format of the technical documentation. The documentation can be in both electronic and paper format. However, the technical file must always be up to date. This means that if there are any modifications to the product or amendments in the relevant directives/regulations, manufacturers should update the content of the file.
What are the language requirements for the technical file?
The technical file must be written in the official language of the Member State where the conformity procedures are to be carried out, or in which the Notified Body is established, or in a language that is accepted by it. Typically, all certification bodies accept technical documentation in English.
We at Clever Compliance can carry out a pre-assessment of your product’s technical documentation before you submit it to a Notified Body. Our compliance experts can also help you create the technical documentation contents according to several CE-marking directives and regulations. For more information, get in touch with us at [email protected].
But if you’re looking for a way to improve your day-to-day compliance operations and a tool that can help you design, create and distribute compliance documentation, then you may want to have a look at our product compliance management system or supplier compliance software.
