The purpose of the “Blue Guide on the Implementation of the Product Rules” (the 2022 Blue Guide) is to contribute to a better understanding of EU product rules and to facilitate their uniform application throughout the single market. The European Commission published its third update to the Blue Guide on 29 June 2022 and it applies to Member States of the EU and EEA, including Iceland, Liechtenstein and Norway, as well as Turkey in some cases.
Aligned with the New Legislative Framework, it covers a wide range of products subject to Union harmonisation legislation, including toys, radio equipment, low voltage electrical equipment, medical devices, and fertilising products. Although non-binding in nature, the Blue Guide is an important and comprehensive guidance document for market surveillance authorities as well as economic operators involved in the product supply chain in the EU.
The Blue Guide provides guidance on a wide variety of product regulatory matters, including the European conformity assessment system, the accreditation of laboratories, CE marking and market surveillance. It also provides guidance on the role and obligations of the various actors in the product supply chain and the regulation of the free movement of products within the EU.
The 2022 Blue Guide builds on its past editions, but also reflects on changes since the previous edition was published in 2016. It addresses changes brought about by new EU legislation, including the adoption of the Market Surveillance Regulation (EU) 2019/1020 (the MSR).
Key amendments to the 2022 Blue Guide include:
‘Making available’ and ‘placing on the market’
Further guidance is now provided on the concepts of ‘making available’ and ‘placing on the market’ in the context of products offered for sale online or through distance selling. In that regard, the 2022 Blue Guide elaborates on the factors that determine whether online or distance selling is targeted at EU end-users and when a product sold by these means is ‘placed’ on the Union market.
Substantial Modification
The 2022 Blue Guide introduces a three-point test to determine when a product, which has been subject to important changes or overhaul after it has been put into service, must be considered a new product:
- Its original performance, purpose or type is modified, without this being foreseen in the initial risk assessment
- The nature of the hazard has changed or the level of risk has increased relating to the relevant Union harmonisation legislation
- The product is made available, or put into service if the applicable legislation also covers putting into service within its scope
Where a modified product is considered a ‘new’ product, the 2022 Blue Guide makes clear that its compliance with the essential requirements must be reassessed and the party that carried out the substantial modification must fulfil the same requirements as the original manufacturer. Those requirements include, for example, the indication of their contact details on the product, the preparation of technical documentation, the drawing up of an EU declaration of conformity and the affixing of a CE mark to the product.
Software
The 2022 Blue Guide contains a new specific section on software. It provides that a manufacturer of a final product has an obligation, as part of its initial risk assessment, to foresee the risks of software integrated in its product at the time of its placing on the market. It also provides that the concept of product safety encompasses not only protection against risks such as mechanical, chemical and electrical risks but also the safety-related aspects of cyber risks and risks related to the loss of connectivity of devices.
As is the case for physical repairs or modifications which result in the creation of a ‘new’ product, the 2022 Blue Guide also introduces a three-point test to determine whether a product should be considered as substantially modified by a software change.
Brexit
The 2022 Blue Guide discusses the impact of the UK’s withdrawal from the EU, including the implications for economic operators, conformity assessment procedures and notified bodies and the implications for Northern Ireland under the Protocol on Ireland/Northern Ireland.
Economic operators are advised to give careful consideration to the 2022 Blue Guide and what, if any, impact the amendments to the guidance may have on their products and procedures. The 2022 Blue Guide can be found on the EU Commission website.
For more information, please contact a member of our Product Regulatory team.
The content of this article is provided for information purposes only and does not constitute legal or other advice.
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