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Attribution of fraudulent conduct by a testing company in the context of the conformity assessment procedure

If a manufacturer of personal protective equipment within the meaning of Article 3 of Regulation (EU) 2016/425 (PPE Regulation) engages a testing company as part of the conformity assessment procedure for its products, it must accept responsibility for any fraudulent conduct on the part of that testing company. This has been decided by the ruling of the Higher Regional Court (OLG) of Frankfurt am Main dated June 25, 2025 (9 U 52/23).

Facts of the case

The ruling of the OLG Frankfurt a.M. is based on the following facts: The plaintiff asserted claims for repayment against the defendant. The defendant is a manufacturer of FFP2 and FFP3 masks. As personal protective equipment (PPE), these are subject to the highest risk category of the PPE Regulation, meaning that a notified body had to be involved in the conformity assessment procedure.

Therefore, the defendant commissioned a testing institute to examine, inter alia, the requirements for affixing the CE mark to the masks. The testing institute then issued certificates confirming the conformity of the masks with the provisions of the PPE Regulation and the applicable European standards for legal purposes. The defendant affixed the CE mark to the masks accordingly.

It turned out later that the testing institute was not approved as a notified body within the meaning of the PPE Regulation. Consequently, the defendant should not have affixed a CE mark to the masks in the absence of a proper conformity assessment procedure. In turn, the lack of a (valid) CE mark led to the masks being defective within the meaning of the warranty provisions under sales law. The purchaser of the masks therefore withdrew from the purchase contract with the defendant and demanded repayment of the purchase price paid. The purchaser then assigned this claim to the plaintiff. The plaintiff is now asserting this claim in court.

Reasons for the decision

The Regional Court (LG) of Frankfurt am Main ordered the defendant to repay the purchase price in full. The defendant appealed against this decision. The appeal was unsuccessful.

The Higher Regional Court of Frankfurt am Main ruled that the testing institute had acted fraudulently (i.e., deliberately and deceptively). By issuing the certificates, it had pretended to be a notified body within the meaning of the PPE Regulation.

The defendant must accept responsibility for this fraudulent behavior. The defendant had a duty towards the plaintiff to sell masks that were free of defects. In order to determine that the masks were free of defects, the defendant had involved the testing company. The latter had checked compliance with the requirements of the PPE Regulation on behalf of the defendant. Accordingly, however, the defendant must also accept responsibility for any errors or fraudulent conduct on the part of the testing company.

The Frankfurt Higher Regional Court also clarified that in the event of fraudulent intent, the strict deadlines for reporting defects (so-called complaint periods) do not apply. Therefore, the asserted warranty rights cannot be excluded on the basis of a potentially delayed notification of defects.

Practical information

The ruling of the Higher Regional Court of Frankfurt demonstrates that caution is required when involving testing institutes in conformity assessment procedures.

In a selection process, manufacturers should therefore always check whether the companies commissioned are actually approved as notified bodies. Manufacturers can use the European Commission's NANDO website for this purpose. The website contains all approved notified bodies; they can be viewed via a search mask in which the applicable European regulation must be entered (https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies).

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