The EU has strengthened the entire system, consisting of manufacturers, importers, distributors, notified bodies, and market surveillance authorities, through the New Legislative Framework. The new legislation aims to reduce burdens on trade while ensuring a high level of safety.
Manufacturers play a crucial role in ensuring that products placed on the extended single market of the European Economic Area (EEA) are safe. They are responsible for checking that their products meet EU safety, health, and environmental protection requirements. It is the manufacturer’s responsibility to carry out the conformity assessment, set up the technical file, issue the EU declaration of conformity, and affix the CE marking to a product. Only then can this product be traded on the EEA market.
If you are a manufacturer, you have to follow these 6 steps to affix a CE marking to your product:
- Identify the applicable directive(s) and harmonised standards
- Verify product specific requirements
- Identify whether an independent conformity assessment (by a notified body) is necessary
- Test the product and check its conformity
- Draw up and keep available the required technical documentation
- Affix the CE marking and draw up the EU Declaration of Conformity (27 KB).
These 6 steps may differ by product as the conformity assessment procedure varies. Manufacturers must not affix CE marking to products that don’t fall under the scope of one of the directives providing for its affixing.
For products that present higher safety risks such as gas boilers, safety cannot be checked by the manufacturer alone. In these cases, an independent organisation, specifically a notified body appointed by national authorities, has to perform the safety check. The manufacturer may affix the CE marking to the product only once this has been done.
Learn about the different categories of products conformity here: ec.europa.eu/growth/single-market/ce-marking/manufacturers_en
Importers and distributors help ensure that only products compliant with EU legislation and bearing the CE marking are placed on the extended Single Market of the EEA. As they are the intermediaries between manufacturers and traders, they must have overall knowledge of the legal requirements and make sure that the products they distribute or import meet them.
When importing from non-EU countries, importers must check that products fulfil all EU safety, health and environmental protection requirements before placing them on the market. The importer has to verify that:
- the manufacturer outside the EU has taken the necessary steps to allow the product to be placed on the EU market
- the necessary documentation such as the EU Declaration of Conformity (27 KB) and the technical documentation is available upon request
- contact with the manufacturer is possible at any time
Distributors must handle the product carefully and they mustn’t affect its compliance with EU legislation. The distributor has to know which products must bear the CE marking and the accompanying documentation. They should be able to identify products that are not in compliance.
Distributors must be able to demonstrate to national authorities that they:
- have confirmation from the manufacturer or the importer that the necessary measures have been taken
- are able to assist national authorities in their efforts to receive the required documentation
If importers or distributors market the products under their own names, they take over the manufacturer’s responsibilities. In this case, they must have sufficient information on the design and production of the product because they will be assuming the legal responsibility when affixing the CE marking.
Although most European manufacturers, importers, and distributors follow the rules, consumers can also play an important role in improving the safety of products:
- Always buy products from trustworthy shops and online outlets: If an offer seems too good to be true, it may well be. Trustworthy shops take care with the products they sell and usually accept returns. On the other hand, rogue traders tend to ignore health and safety rules, and may also sell fake products.
- Read all warnings and instructions: Be aware of age and safety recommendations, especially in the case of toys.
- Always report a safety problem: Inform the manufacturer or the retailer from whom you bought the product. In addition, contact the appropriate public authority. This ensures that further steps to ensure the safety of the product will be taken.
Standards are technical specifications defining requirements for products, production processes, services or test-methods. These specifications are voluntary. They are developed by industry and market actors following some basic principles such as consensus, openness, transparency and non-discrimination. Standards ensure interoperability and safety, reduce costs and facilitate companies’ integration in the value chain and trade.
European Standards are under the responsibility of the European Standardisation Organisations (CEN, CENELEC, ETSI) and can be used to support EU legislation and policies.
The Safety Gate provided by the European Commission is a rapid alert system for dangerous non-food products. The Safety Gate rapid alert system enables quick exchange of information between EU/EEA member states, the UK and the European Commission about dangerous non-food products posing a risk to health and safety of consumers.
The Product Safety Business Alert Gateway allows businesses to report dangerous products to the EU Member State authorities.
Spotlight On Covid-19 Related Medical Products
The European Commission has published information on:
- conformity assessment for protective equipment
- conformity assessment for 3D printing and 3D printed products to be used in a medical context
- applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution)
- 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
Learn more about European Standards here.
Learn more about the CE Marking in Ireland here: een.ec.europa.eu
If you need information on doing business in Europe or up-to-date European legislation for:
- CE Marking and Standards
- Export documentation
- Certification of origin service
- Labelling legislation
you can contact your local Enterprise Europe Network Ireland centre for further information on legislation and certification here.