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In brief

The publication of the July 2022 version of the European Commission’s Blue Guide on the implementation of European Union product rules aims to adapt to changes in European legislation on the marketing of products within the EU. In this sense, the aim is to improve the understanding of EU legislation and its application in the fields that make up the single market. The Guide is for guidance only, which means that it has no legal force. Among the most relevant changes are the introduction of specific sections on product repairs, software, online sales and Brexit.


Contents

  1. In more detail

In more detail

Background

On 29 July 2022, the European Commission published a new version of the Blue Guide, on the implementation of European Union product rules 2022 (“the Guide“), which includes some content modifications compared to its previous version published in 2016. Since its initial publication in 2000, the Guide has become the reference document for understanding how European Union (EU) legislation has to be applied from a new and comprehensive approach. The Guide applies to the EU Member States and to the signatory states of the Agreement on the European Economic Area (plus Turkey in some specific cases). 

The main aim is to improve the understanding of EU product regulations and their uniform application in a number of sectors that are part of the single market. The areas covered include machinery, medical devices, toys and electrical equipment, among others. The Guide is a document of a merely indicative nature and therefore does not have the legal force of an EU harmonisation act. In addition, it is worth mentioning that the text of the published document itself foresees the possibility that its content may be modified if the EU legal framework undergoes changes, and that new interpretations may be adopted in the future.

New developments

The Guide introduces a number of changes in order to adapt to the challenges posed by new regulations, particularly in the e-commerce sector. Highlights of the changes include the following:

Repairs and modifications to products

The Guide establishes when a product that has undergone significant changes or reviews since it was put into service shall be considered as a new product, such as when its original performance or purpose is modified, when its hazard level has changed or increased or when the product is commercialized. In these cases, a conformity assessment procedure must be carried out.

It should be noted that when a product that has been modified is sold under the name of a person other than the original manufacturer, the product is considered to be a new product. The person making changes to the product shall verify whether it is considered a new product and, if so, shall become the manufacturer of the product. In such cases, the product must undergo a conformity assessment before being placed on the market, and the name and address of the new manufacturer must also be indicated.

Finally, the Guide explains that repaired products that do not qualify as new do not have to undergo a conformity assessment since maintenance operations are excluded from the scope of EU harmonisation legislation. However, for certain products, manufacturers are obliged to provide spare parts for repairs.

Software

The Guide provides a new section on software, which clarifies that the manufacturer is responsible for preventing the risks of the software that makes up a product at the time it is placed on the market. There is a broad definition of product safety, which covers any type of risk arising from the product.

Provided that a product already introduced in the market is not modified, maintenance operations may include informatics upgrades. In order to consider that products have been modified through informatics changes, the same criteria set out in the section on “Repairs and modifications to products” shall apply.

Distance and online sales

For online sales, the Guide sets that products shall be deemed to have been marketed within the EU and therefore have to comply with the applicable EU rules, provided that they are offered to end-users in the EU. This shall require an analysis of all factors applicable to websites targeting end-users in the EU, such as: expected delivery in the EU, acceptance of payment from EU end-users, use of EU languages or physical delivery of the product to EU end-users.

The Guide also recommends providing the CE marking in a visible way on websites selling products before the end-user proceeds with the purchase of such products. Finally, it is also stressed that the online sale of a product is not equivalent to placing it on the EU market for the first time.

Withdrawal of the United Kingdom from the European Union

The Guide has a new section explaining that manufacturers and importers established in the United Kingdom (UK) are not considered EU economic operators and must therefore comply with all obligations applicable to importers. In this regard, economic operators performing specific tasks in multiple product sectors may not be established in the UK and must be located in the EU.

Regarding the conformity assessment procedure, the UK Notified Bodies are no longer valid and it is necessary to apply to the EU Notified Bodies to obtain the relevant certificates of conformity. Likewise, the UK accreditation service is also no longer a valid accreditation body nowadays.

Notwithstanding the above, from 1 January 2021, through the Protocol on Ireland and Northern Ireland certain provisions of EU law and EU harmonisation legislation also apply to Northern Ireland.

Considerations

With this latest update of the Guide, operators involved in the manufacturing, distribution and marketing chain of the products covered by the Guide should review whether they are adequately complying with the EU provisions covered by the Guide. 

Related content

For more information, please see the full text of the Guide published at this link.

Author

Montserrat Llopart is a Partner in the International Commercial & Trade department and leads the Compliance and Healthcare Law practices in the Barcelona office. Her practice focuses on advising clients on regulatory, compliance, commercial contracts, consumer and acquisitions issues. She is a regular speaker and contributor to specialist conferences and publications and she is recognized by the leading legal directories as Chamber, Legal 500 and Best Lawyers and as InspiraLaw Top 50 Women List for Spain and Portugal. Montserrat headed the Barcelona office and the Firm's pharmaceutical law group in the EMEA region.

Author

Elisabet is a Senior Associate experienced Public Law/ Regulatory lawyer in Baker McKenzie's Barcelona office. She has more than 10 years' experience advising heavyweight companies on public law and regulatory issues. Elisabet advises both national and multinational companies on public procurement, administrative compliance, license schemes, environmental, ESG, regulatory, and products-related matters (circular economy and sustainability requirements, green claims, consumer protection issues, etc), including assistance before regulators, authorities, and courts. In addition, she regularly advises private companies on regulatory issues related to business expansion and the opening of new plants/premises. She also advises on litigation and trials related to the areas of specialization. She has extensive experience in the consumer & goods and life sciences sectors. Regarding the life sciences sector, she offers advice to Spanish and foreign life sciences companies and represent them before authorities and courts regarding public procurement issues, price & reimbursement procedures, authorization and registration, promotion and advertising of medicines, and other regulatory issues related to medicinal products, medical devices, cosmetics, food supplements and other foods for particular nutritional uses. She also professor at Pompeu Fabra University, UPF Barcelona School of Management and ESADE Law School in the field of Public Law. She regularly participates in publications and articles related to her specialty.

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