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
Many products require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.
When is CE marking mandatory?
CE marking is only obligatory for products for which EU specifications exist and require the affixing of CE marking.
Some products are subject to several EU requirements at the same time. You must make sure that your product complies with all the relevant requirements before affixing the CE marking to it. It is forbidden to affix the CE marking to products for which EU specifications do not exist or do not require the affixing of CE marking.
How to obtain CE marking?
As the product's manufacturer, you bear sole responsibility for declaring conformity with all requirements. You don't need a license to affix the CE marking to your product, however, before doing so, you must:
- ensure conformity with all relevant EU-wide requirements
- determine whether you can assess your product by yourself or if you have to involve a notified body
- put together a technical dossier documenting conformity: find out about technical documentation
- draft and sign an EU declaration of conformity
Once your product bears the CE marking — if the competent national authority requests — you must provide them with all the information and supporting documentation concerning CE marking.
Do you need an independent assessment?
You need to check if your product has to be tested by a notified body. You can find this information in the relevant legislation applicable to your product: check the rules by product category.
This step is not obligatory for all products.
If you need to involve a notified body, the CE marking must be accompanied by the identification number of the notified body. The CE mark and the identification number can be affixed separately, as long as they appear clearly linked to each other.
You can use the Nando database to search for a notified body that can certify your product.
If your product doesn't need to be verified by an independent body, then it is up to you to check that it complies with the technical requirements. This includes estimating and documenting the possible risks when using your product.
Do you need to pay any fees?
If you as a manufacturer carry out the conformity assessment yourself, you won't have to pay any fees. However, if you opt to use the services of a notified body, or if the EU specifications applicable to your product require the independent assessment by a notified body, then you must pay the notified body for the service they provide. The cost depends on which certification procedure that applies to your product and the complexity of the product etc.
How do you affix the CE marking?
The CE marking must be visible, legible and indelible.
The CE marking must consist of the initials "CE", both letters should have the same vertical dimension and be no smaller than 5mm (unless specified differently in the relevant product requirements).
If you wish to reduce or enlarge the CE marking on your product, you should respect the proportions of the two letters. As long as the initials remain visible, the CE marking can take different forms (for example colour, solid or hollow).
If the CE marking cannot be affixed to the product itself, you can affix it to the packaging if there is any, or to any accompanying documents. If your product is subject to several EU directives/regulations which require a CE marking to be affixed, the accompanying documents must indicate that your product conforms to all applicable EU directives/regulations.
You can download the CE marking image files from the DG GROW portal.