2022 ‘Blue Guide’ – the updated EU product rules

Europe

On 29 June 2022 the European Commission published its revised ‘Blue Guide’ on the implementation of EU product rules. For over 20 years, the Blue Guide has been one of the main reference documents explaining how to implement and apply the EU product rules across different sectors and throughout the single market. It applies to Member States of the EU and EEA, including Iceland, Liechtenstein and Norway, as well as Switzerland and Turkey in certain cases.

The Blue Guide was first published more than two decades ago, in 2000, and was updated in 2014 and 2016. Although intended purely as a guidance document, it provides an explanation related to a wide range of products covered by Union harmonisation legislation (i.e., CE-marked products). The Guide generally discusses the non-food and non-agricultural products referred to as industrial products or products whether for use by consumers or professionals. These include electrical and electronic equipment, toys, machinery, radio equipment, medical devices and personal protective equipment, amongst many other things.

The 2022 revision of the Guide generally elaborates on the existing version, but also includes the following key amendments:

Distance and online sales to the EU market: In a dedicated new section, the Blue Guide clarifies when products offered for sale online or through other means of distance sales are deemed to be available on the Union market, and what the market surveillance authorities’ powers are in that regard. The key criterion is whether the offer is targeted at EU end users.

Products modifications and repairs: The updated Guide clarifies when a modified product is considered a new product, and therefore when it must comply with the provisions of the applicable legislation when it is made available on the market or put into service. This has to be verified by applying the appropriate conformity assessment procedure. When the modified product is considered a new product, then the person carrying out the substantial modification has to fulfil the same requirements as an original manufacturer, for example by preparing technical documentation, drawing up an EU declaration of conformity, and affixing the CE marking on the product. With respect to the repaired products, the Blue Guide clarifies that basically maintenance operations are excluded from the scope of the EU legislation. For example, if the original performance of a product is modified (within the intended use, range of performance and maintenance originally conceived at the design stage) because the spare-parts used for its repair perform better due to technical progress, this product is not to be considered new, according to EU legislation.

Software: A new section on software explains that at the time a product is placed on the market, manufacturers of software integrated in final products (e.g. a medical device or an in-vitro diagnostic medical device) have obligations to anticipate that product’s risks, including not only mechanical, chemical, electrical risks but also the safety-related aspects of cyber risks and risks related to the loss of connectivity of devices. Generally, software updates or repairs could be assimilated to maintenance operations. However, the Blue Guide details the cases where a product will be considered as substantially modified by a software change, and hence will require reassessment (e.g. the software update modifies the original intended functions, type or performance of the product and this was not anticipated in the initial risk assessment).

Instructions and safety information: The Guide now explicitly explains that while the safety information needs to be provided on paper, the set of product instructions may be provided on a website and must remain accessible for a reasonable period after the product was placed on the market, depending on the product’s intended use. However, a paper version should always be available free of charge for consumers upon request.

Modernisation of market surveillance provisions: A number of changes have been made as a result of the new Regulation (EU) 2019/1020 on market surveillance and the compliance of products, which improves and harmonises the requirements on non-food products at EU level, in particular by: (i) providing information and carrying out activities to promote compliance; (ii) providing more effective enforcement tools to address online sales; (iii) improving cooperation between Member States, between market surveillance and customs authorities, and through an EU product compliance network; (iv) providing a comprehensive framework for controls on all products (in harmonised and non-harmonised areas) entering the EU market.

Brexit: The Blue Guide includes explanations regarding the United Kingdom’s withdrawal from the European Union and the respective consequences, including implications for economic operators, conformity assessment procedures, and notified bodies. In the context of Brexit, the updated Blue Guide also discusses the application of the Protocol on Ireland/Northern Ireland, applicable since 1 January 2021.

The revised 2022 Blue Guide remains a substantial tool assisting the businesses involved in the product supply chain in the EU to better understand and apply the provisions of the EU legislation. Companies, which may be concerned by the updated rules, are advised to consider the necessity of additional alignment of their products and internal procedures.