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No.
The Commission FAQ explains that a non-EU manufacturer needs an economic operator established in the Union to perform the Article 4 tasks under Regulation (EU) 2019/1020. Depending on the setup, that can be an importer, an authorised representative or, where no other such operator exists, a fulfilment service provider.
section 4.6.1
The authorised representative performs the tasks specified in the written mandate from the manufacturer. At minimum, that mandate must allow it to:
- keep the EU declaration of conformity and technical documentation at the disposal of market surveillance authorities
- provide the relevant information and documentation to market surveillance authorities on request
The authorised representative must also provide a copy of its mandate to market surveillance authorities on request.
Article 18(3)
The authorised representative cannot take over the manufacturer's core product-compliance obligations listed in Article 13(1) to (11), Article 13(12), first subparagraph, and Article 13(14).
That means the authorised representative can help with documentation and authority-facing tasks, but it does not supersede the manufacturer for the core design, risk assessment, conformity assessment and ongoing compliance duties that the CRA keeps with the manufacturer.
Article 18(2)-(3)
Before placing a product on the market, the importer must ensure that:
- the manufacturer carried out the appropriate conformity assessment
- the manufacturer drew up the technical documentation
- the product bears the CE marking and is accompanied by the declaration of conformity and Annex II information and instructions in an understandable language
- the manufacturer complied with the identification, contact-detail and support-period-end-date obligations in Article 13(15), (16) and (19)
Article 19(1)-(2)
If the importer considers or has reason to believe that the product or the manufacturer's processes are not in conformity, it must not place the product on the market until conformity is restored.
If the product presents a significant cybersecurity risk, the importer must inform the manufacturer and the market surveillance authorities. After placement on the market, if the importer becomes aware of a vulnerability, it must inform the manufacturer without undue delay and, where there is a significant cybersecurity risk, also inform the relevant market surveillance authorities.
Article 19(3), Article 19(5)
The importer must keep a copy of the EU declaration of conformity at the disposal of market surveillance authorities for at least 10 years after placement on the market or for the support period, whichever is longer. It must also ensure that the technical documentation can be made available and must provide the necessary information and documentation further to a reasoned request.
Article 19(6)-(7)
Before making a product available on the market, the distributor must verify that:
- the product bears the CE marking
- the manufacturer and the importer complied with the documentation and traceability obligations listed in Article 20(2)
- the necessary documents have been provided to the distributor
The distributor must also act with due care in relation to the CRA's requirements.
Article 20(1)-(2)
If the distributor considers or has reason to believe that the product or the manufacturer's processes are not in conformity, it must not make the product available until conformity is restored.
If the distributor later knows or has reason to believe that a product it has made available is not in conformity, it must make sure that corrective measures, withdrawal or recall are taken as appropriate. Upon becoming aware of a vulnerability, it must inform the manufacturer without undue delay and, where there is a significant cybersecurity risk, immediately inform the relevant market surveillance authorities.
Article 20(3)-(4)
Further to a reasoned request, the distributor must provide the information and documentation necessary to demonstrate conformity and cooperate with the market surveillance authority on measures to eliminate cybersecurity risks.
If the distributor becomes aware that the manufacturer has ceased operations and can no longer comply with the CRA, it must inform the relevant market surveillance authorities without undue delay and, to the extent possible, also inform the users of the products placed on the market.
Article 20(5)-(6)
An importer or distributor becomes the manufacturer for CRA purposes if it:
- places the product on the market under its own name or trademark, or
- carries out a substantial modification of a product already placed on the market
In that case it becomes subject to Articles 13 and 14 as manufacturer.
Article 21
section 3.1, section 3.3, section 3.4
A natural or legal person other than the manufacturer, importer or distributor that carries out a substantial modification and makes the product available on the market is also treated as the manufacturer.
That person becomes subject to the CRA manufacturer obligations for the affected part of the product or, if the substantial modification affects the cybersecurity of the product as a whole, for the entire product.
Article 22
On request, economic operators must provide the market surveillance authorities with the name and address of the operator who supplied them with the product and, where available, the operator to whom they supplied it.
They must be able to present that information for 10 years after they were supplied with the product and for 10 years after they supplied it.
Article 23
Not as a named CRA operator category in Articles 18 to 23.
But the Commission FAQ explains that, for CRA-covered products, a fulfilment service provider established in the Union can act as the Article 4 responsible operator under Regulation (EU) 2019/1020 where there is no Union manufacturer, importer or authorised representative.
Article 3(12), Articles 18-23
section 4.6.1
No.
The CRA says that where an entity only provides online intermediation services for a given product and is merely a provider of an online marketplace, it does not qualify as one of the CRA economic operators for that product. But if the same entity also distributes that product, sells it under its own brand, or otherwise acts in an economic-operator role, it must comply with the obligations of that role.
recital 78
No.
The CRA says the sole act of hosting products with digital elements on open repositories, package managers or collaboration platforms does not by itself amount to making them available on the market. A provider of such a service is treated as a distributor only if it actually makes the software available on the Union market in the course of a commercial activity.
recital 19