EU digital legislation

CRA-Update – Episode 4: What are the obligations of the importer under the CRA-E?

The role of the importer becomes relevant within the proposed Cyber Resilience Act (CRA-E) when he makes available a product with digital elements bearing the name or trademark of a (legal) person and being established outside the European Union on the Union market for the first time.

In the event that a manufacturer is located in a third country, an importer established in the Union must always be involved in the product supply chain, whereas the legal figure of the importer is not required if a manufacturer is located within the EU, since the product with digital elements must not be placed on the market by an intermediary in this case.

In principle, the importer is not involved in the manufacturing process, but only in the distribution of the product with digital elements. This circumstance is also taken into account by the CRA-E with the obligations laid down in Art. 13 CRA-E.

Art. 13 (1) CRA-E stipulates that importers shall only place on the market and thus first making available on the Union market products with digital elements that are compliant with the essential requirements in Annex I. In practice, this will include two main courses of action: On the one hand, the importer can make the product with digital elements available on the Union market by reselling it to the distributor. On the other hand, he can also sell the product directly to the end customer. This is because the regulation defines “making available” on the market in Art. 3 (23) CRA-E as “any supply of a product with digital elements for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.” Moreover, the concept of a distributor (Art. 3 (21) CRA-E) differs from that of an importer (Art. 3 (20) CRA-E) only by the fact that the former merely makes the product with digital elements available on the market and is neither a manufacturer nor importer.

The importer must ensure that the essential cybersecurity requirements are met and that the manufacturer has implemented appropriate procedures to address vulnerabilities. Since this can be demonstrated with the help of the declaration of conformity, the technical documentation and the other information and instructions for use to be attached in accordance with Annex II, the importer must ensure pursuant to Art. 13 (2), (5) CRA-E that the aforementioned evidence is available and attached to the product with digital elements. This evidence can be attached either in electronic form (e. g. via an internet address) or in paper form and must be written in a language which can be easily understood by users.

In this context, Art. 13 (3) CRA-E clarifies that the importer may not place the product on the market if there are doubts about conformity. Consequently, there is a high liability risk here and thus also a high review effort for the importer. In addition, Art. 13 (4) CRA-E stipulates that the importer must deposit his own contact information with the product with digital elements, which underpins his responsibility for ensuring conformity. This is also supported by the fact that, according to Art. 13 (6) CRA-E, the importer must take corrective measures himself for the products with digital elements that he places on the market and must inform the manufacturer and, if necessary, the market surveillance authorities if a vulnerability is identified.

In addition, according to Art. 13 (7) CRA-E, the importer shall keep a copy of the EU declaration of conformity for a period of ten years from the date on which the product with digital elements was placed on the market and present it to the market surveillance authority upon request. According to Art. 17 (2) CRA-E, the same retention period applies to contact information of all economic operators from whom the importer has obtained products with digital elements or to whom he has supplied such products. Furthermore, market surveillance authorities and product users must be informed as soon as the importer becomes aware that the manufacturer of a product with digital elements ceased its operations, Art. 13 (9) CRA-E.

The CRA-E provides a special feature in Art. 15. According to this, the importer is considered a "deemed" manufacturer if he makes a substantial modification to a product with digital elements that has already been placed on the market, with the consequence that he is subject to the obligations of the manufacturer at least for the parts of the product that are affected by the substantial modification. According to Art. 3 (31) CRA-E, a substantial modification takes place if the product with digital elements is modified after it has been placed on the market in such a way that the intended use determined during the conformity assessment is changed or if the modification has a general impact on the conformity of the product and its requirements in Annex I Section 1. Thus, as soon as the importer interferes with the nature of a product with digital elements that has been placed on the market, there is a risk that his scope of obligations will be greatly expanded.

Practical recommendations:

Companies that import digital products into the Union market should review both the material and personnel scope provisions of the CRA-E to determine whether they fall within the definition of the importer. If this is the case, we recommend that appropriate processes be put in place to adequately address the extensive verification obligations, as there is a high risk of liability in this regard. Furthermore, it should be ensured as far as possible that no significant changes are made to the imported products with digital elements in order not to fall under the manufacturer fiction.

In our CRA-Update series, we regularly present information on the proposed Cyber Resilience Act and keep you informed about changes in the ongoing legislative process. In each of our articles, we give you a brief overview of a specific topic, presenting the most important aspects and practical implications.

Lawyer, Associate
Alexander Weiss
Lawyer, Associate
Alexander Weiss

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CRA-Update

CRA-Update – Episode 10: Penalties under the CRA-E

With the proposed Cyber Resilience Act (CRA-E), the European Commission has set itself the goal of strengthening the security of products with digital elements with horizontal legal requirements in order to better protect the European internal market from growing cyber threats. Concerning this matter, the regulation contains a large number of obligations that apply to all economic operators in a product supply chain, namely manufacturers, importers and distributors.

CRA-Update – Episode 9: Surveillance authorities

The Commission's draft for the Cyber Resilience Act (CRA-E) mentions different authorities with different tasks for monitoring and compliance with the standards of the regulation.

CRA-Update – Episode 8: The conformity assessment procedure

In order to demonstrate the conformity of products with digital elements with the requirements of the proposed Cyber Resilience Act (CRA-E), manufacturers must carry out a so-called conformity assessment procedure in accordance with Art. 24 (1) CRA-E. For this purpose, the CRA-E basically provides for three different types of procedures, for each of which information can be found in Annex VI. The procedures mentioned there are based on Decision 768/2008/EC, which aims to establish a common framework for legislation harmonizing the conditions for the marketing of products and provides for conformity assessment procedures for this purpose.

CRA-Update – Episode 7: What are vulnerability handling processes put in place by manufacturers and when are they compliant under the CRA?

According to Art. 1 (c) of the planned Cyber Resilience Act (CRA-E) this regulation should also include provisions for vulnerability handling processes put in place by manufacturers. The purpose of these processes is to ensure the cybersecurity of products with digital elements during the whole life cycle.

CRA-Update – Episode 6: When is a product with digital elements in conformity with the requirements of the CRA-E?

The planned Cyber Resilience Act (CRA-E) aims to establish uniform EU cybersecurity requirements for products with digital elements in order to handle the growing threat of cyberattacks. For this purpose, the regulation stipulates numerous obligations that primarily affect the manufacturers of such products.

 

CRA-Update – Episode 5: What are the obligations of the distributor under the CRA-E?

Being the last economic operator in the supply chain of products with digital elements, the distributor falls within the scope of the proposed Cyber Resilience Act (CRA-E) as well.

According to the definition in Art. 3 (21) CRA-E, a (legal) person can only fall under the term of the distributor if it makes a product with digital elements available on the Union market without affecting its properties and without being already qualified as a manufacturer or importer.

CRA-Update – Episode 4: What are the obligations of the importer under the CRA-E?

The role of the importer becomes relevant within the proposed Cyber Resilience Act (CRA-E) when he makes available a product with digital elements bearing the name or trademark of a (legal) person and being established outside the European Union on the Union market for the first time.

CRA-Update – Episode 3: What are the obligations of the manufacturer under the CRA-E?

In comparison to the other economic operators, the manufacturer is subject to the most comprehensive obligations of the proposed CRA (CRA-E). This is probably because the manufacturer significantly controls the development of the product with digital elements, determines its characteristics and can thus influence the inherent cybersecurity risks. The specific obligations for manufacturers are set out in Art. 10 and 11 of the proposed CRA.

CRA-Update – Episode 2: Who falls within the scope of the proposed CRA?

According to section II of the proposed CRA the regulation will apply to so-called economic operators such as manufacturers, authorised representatives, importers and distributors of products with digital elements.

CRA-Update – Episode 1: Which products fall within the scope of the proposed CRA?

The current proposal for a new European Cyber Resilience Act by the European Commission from 15th September 2022 (CRA) applies to products with digital elements whose intended or reasonably foreseeable use includes a direct or indirect logical or physical data connection to a device or network (see recital 7 and Art. 2 (1) of the proposed CRA).