EU and US Regulations on Instructions for Use: Find the Differences! (Part 1)

In the EU, a manufacturer can use European harmonized standards to comply with the relevant essential health and safety requirements of the CE marking directives and accordingly affix CE marking. Many of these CE marking directives also set requirements for instructions for use.
Although there are many similarities, the process of product compliance in the US is slightly different from the process of EU compliance.

In this part, Ferry Vermeulen and Michael Gerrits, describe the requirements in the EU. In the next part, which is published next week, the US requirements for instruction for use are laid out, and a comparison is made with the EU rules.

[custom_headline type=”left” level=”h2″ looks_like=”h3″ accent=”false”]Product Safety in the EU[/custom_headline]

[custom_headline type=”left” level=”h3″ looks_like=”h4″ accent=”false”]Introduction CE marking[/custom_headline]
The European New Approach Directives form the starting point of the CE marking (Conformité Européenne). CE marking is a key indicator of the compliance of a product with the relevant EU legislation. When a product complies with the applicable EU legislation, the free movement of products within the European market is enabled. By affixing the CE marking on a product, the product’s manufacturer (the importer of a product from outside the EU is legally considered as the manufacturer too) declares, on his sole and ultimate responsibility, conformity with all of the legal requirements to achieve CE marking. With this, the manufacturer ensures validity for that product to be sold throughout the European Economic Area, as well as Turkey. The procedure of CE marking also applies to products made in third countries, which are sold in the EEA and Turkey. The European Commission draws up the legislation. Accordingly, the EU member states have to implement the exact legislation in their national laws (except for Regulations that are directly applicable).

What CE marking (not) means:

  • CE marking merely states that the product is assessed on safety, health and environmental protection requirements before being placed on the market and thus satisfies the legislative requirements (e.g. a harmonized high level of safety) to be sold there;
  • The CE mark means that the manufacturer (or its authorized representative or the importer) has verified that the product complies with all relevant essential requirements of the applicable directive(s) and/or regulations.
  • The CE mark can indicate that a notified body, if required by the applicable directive(s) and/or regulations (for certain products that present inherently higher risks), has examined the product. A notified body is an independent organization, appointed by national authorities, that performs the safety check.
  • CE marking, however, does not indicate that the product has been approved as safe by the European Union or by another authority.
  • The CE mark is not an indication that a product was made in the EEA.

When a product is subject to CE marking, it is the manufacturer’s responsibility to carry out the conformity assessment, to draw up the technical file and the EC declaration of conformity and to affix CE marking on the product. It’s the responsibility of distributors to verify the presence of both the CE marking and the required documentation. If the product is being imported from a country outside the EU, it is the importer’s responsibility to ensure that the manufacturer outside the EU has undertaken all the required steps and that the documentation is available upon request.

[custom_headline type=”left” level=”h3″ looks_like=”h4″ accent=”false”]Regulated Products in the EU[/custom_headline]

Not all products are part of CE marking and thus not all products have to bear the CE marking logo. In fact, the CE mark shall be affixed only to products to which its affixing is provided for by specific EU harmonization legislation. CE Marking harmonization legislation (European Union legislation that require the affixing of a CE mark to the products covered by them) have been developed for product groups like medical devices, machinery, toys and radio and telecommunications terminal equipment. In total there have been developed pieces of legislation for over 20 product groups.

[custom_headline type=”left” level=”h3″ looks_like=”h4″ accent=”false”]Non-Regulated Products in the EU[/custom_headline]

Consumer products

The General Product Safety Directive 2011/95/EC (GPSD) has been developed to ensure a high level of product safety throughout the EU. The GPSD applies to all consumer products that are not (or just partly) covered by specific EU sector legislation (e.g. outdoor furniture, gymnastic equipment, child use and care articles, lighters, floating leisure articles for use on and in the water). The Directive also complements the provisions of sector legislation which do not cover certain matters, for instance in relation to importers’ obligations and the authorities’ powers and tasks. The objectives of the GPSD are both to protect consumer health and safety (by ensuring that only safe consumer products will be placed on the EU market) and to ensure the proper functioning of the internal market.

The GPSD gives a generic definition of what a safe product is. According to this definition, a safe product:

“shall mean any product which, under normal or reasonably foreseeable conditions of use including duration and, where applicable, putting into service, installation and maintenance requirements, does not present any risk or only the minimum risks compatible with the product’s use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons (…)”

In particular, the Directive takes the following points into account:

  1. the characteristics of the product, including its composition, packaging, instructions for assembly and, where applicable, for installation and maintenance;
  2. the effect on other products, where it is reasonably foreseeable that it will be used with other products;
  3. the presentation of the product, the labeling, any warnings and instructions for its use and disposal and any other indication or information regarding the product;
  4. the categories of consumers at risk when using the product, in particular children and the elderly.

Products must comply with the given definition. In the absence of specific EU harmonization rules, the safety of a product is assessed in accordance with:

  • European (harmonized) standards,
  • Rules or standards drawn up in the Member State in which the product is marketed,
  • EU technical specifications,
  • Codes of good practice (e.g. Tampon Code of Practice),
  • The state of the art, and
  • The reasonable expectations of consumers.

Professional products

For non-regulated non-consumer goods no EU harmonization legislation exists. As a result, these products shall conform to the specific rules of national law of the Member State(s) in whose territory the product is marketed and laying down the health and safety requirements which the product must satisfy in order to be marketed.

[custom_headline type=”left” level=”h3″ looks_like=”h4″ accent=”false”]Product Liability in the EU[/custom_headline]

As a manufacturer, importer or distributor you should make sure that the products you market are safe and comply with the applicable product safety legislation. You can be held responsible for damage caused by defects to your products. By ensuring that your products comply with the relevant safety requirements, you will generally avoid product liability claims for defective products.
Directive 85/374/EEC concerning liability for defective products lays down the principles of product liability in the EU. This Directive establishes the principle of liability without fault applicable to producers. Where a defective product causes damage to a consumer, the producer may be liable. The legislation applies to all movable products, e.g. consumer products, pharmaceuticals, agricultural products and electricity.

All circumstances are taken into account when deciding whether a product is defective, including:

  • The manner in which a product is marketed (including sales literature);
  • Any instructions or warnings that are given with it;
  • What might reasonably be expected to be done with it;
  • The time the producer supplied the product.

The producer will be held responsible if there is a causal relationship between the defect in a product and the damage, meaning that it is clear that the product was defective and the defect caused the damage.

[custom_headline type=”left” level=”h3″ looks_like=”h4″ accent=”false”]CE marking and instructions[/custom_headline]

The fundamental requirements, as set out in the CE marking directives, also include requirements regarding documentation (user’s manual, installation instructions, maintenance prescriptions, EC declaration). Most directives require “adequate” instructions for use. In the more detailed (product specific) harmonized European standards can be found how to meet these requirements technically.

The European harmonized standard EN-IEC 82079–1 Preparation of Instructions For Use gives concrete (minimal) requirements for the instructions for use.

[alert]Next week part 2 of this article will be published. Part 2 will elaborate on the US rules and requirements for User Manuals and Instructions for Use.[/alert]
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