Technical documentation and EU declaration of conformity
Coronavirus, medical supplies and protective equipment
- EN 149:2009 Respiratory protective devices – Filtering half masks to protect against particles - Requirements, testing, marking (commonly referred to as 'FFP masks')
- EN 14683:2019 EN Medical face masks - Requirements and test method
- EN 166:2001 Personal eye-protection – Specifications
- EN 14126:2003 Protective clothing - Performance requirements and tests methods for protective clothing against infective agents
- EN 14605:2009 Protective clothing against liquid chemicals - performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only
- EN 13795-1:2019 Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
- EN 13795-2:2019 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
- EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes (MDD)
- EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties (MMD)
- EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation (MDD)
- EN 455-4:2009 EN Medical gloves for single use - Part 4: Requirements and testing for shelf life determination (MDD)
- EN ISO 374-5:2017 Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks
- EN ISO 13688:2013 Protective clothing - General requirements
- EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
The technical documentation provides information on the design, manufacture, and operation of a product and must contain all the details necessary to demonstrate the product conforms to the applicable requirements.
If you are the manufacturer, there are certain rules that must be followed when placing a product on the market; you must:
- prepare the technical documentation before placing a product on the market
- ensure the technical documentation is made available to the market surveillance authorities (should they request to see it) as soon as the product is placed on the market
- keep the technical documentation for 10 years from the date the product is placed on the market (unless explicitly specified otherwise)
The technical documentation is necessary to prove the product meets the essential requirements and therefore justify and support an EU declaration of conformity. You need this documentation in order to affix the CE marking to the product.
How to draw up the technical documentation?
The technical documentation should include at least:
- your name and address, or those of any authorised representatives
- a brief description of the product
- identification of the product, for example, the product's serial number
- the name(s) and address(es) of the facilities involved in the design and manufacture of the product
- the name and address of any notified body involved in assessing the conformity of the product
- a statement of the conformity assessment procedure that has been followed
- the EU declaration of conformity
- label and instructions of use
- a statement of relevant regulations to which the product complies
- identification of technical standards with which compliance is claimed
- list of parts
- test results
As a manufacturer, you should be able to demonstrate where and how the various parts of the document are held and maintained.
You can usually choose in which language you want to prepare the technical documentation. However, the market surveillance authorities may ask you to translate the technical documentation depending on the EU country where the product has been placed on the market. If requested, you can also provide it in electronic format.
As a manufacturer, you are responsible for identifying all the possible risks your product could pose and determine the applicable essential requirements. This analysis must be included in the technical documentation. In addition, you will need to explain the ways in which you have addressed the risks identified to ensure that your product complies with the applicable requirements, for example, by applying harmonised standards.
EU declaration of conformity
An EU declaration of conformity (DoC) is a mandatory document that you as a manufacturer or your authorised representative need to sign to declare that your products comply with the EU requirements. By signing the DoC you take full responsibility for your product's compliance with the applicable EU law.
How to draw up a declaration of conformity
As a manufacturer, it is your responsibility to draw up the EU declaration of conformity(DoC). It should contain the following information:
- your name and full business address or that of your authorised representative
- the product's serial number, model or type identification
- a statement, stating you take full responsibility
- means of identification of product allowing traceability – this can include an image
- the details of the notified body which carried out the conformity assessment procedure (if applicable)
- the relevant legislation with which the product complies, as well as any harmonised standards or other means used to prove compliance
- your name and signature
- the date the declaration was issued
- supplementary information (if applicable)
For imported products, the importer must ensure that the product is accompanied by the DoC and must keep a copy of it for 10 years after the product has been placed on the market.
You must translate the EU declaration of conformity into the language or languages required by the EU country in which your product is sold.