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Regulatory updates for the medical device industry

With the TÜV SÜD Octagon, what you see is what you get

Can there still be anybody unfamiliar with the blue TÜV SÜD octagon, one of the best-known certification marks in the world? Manufacturers and consumers worldwide place their trust in the octagon, and rely on products identified by this mark to offer safety and functionality. In 2016, a web link was added to the mark, directing users to a public database containing all certificates issued by TÜV SÜD. There, users can verify the authenticity of a certificate, and look up the key information associated with a certification mark.

According to the verdict of 21 June, 2016 – I ZR 26/15 of the German Federal Court of Justice (Bundesgerichtshof, BGH), B2C advertising that uses certification marks without providing further information about the underlying tests is unacceptable. All consumers must have the possibility to inform themselves in more detail about the content of a certification mark. The certification mark must be supplemented by a reference, e.g. a link to the source of information. As a manufacturer, you can rest assured that thanks to the new TÜV SÜD certification marks in conjunction with the certificate database, your advertising featuring our blue TÜV SÜD octagon is in compliance with legal requirements. The new certification marks are available for download in the TÜV SÜD Download Centre.

The legal position

In its written judgement on the verdict, the BGH explains that provision of a reference with more detailed information on the certification criteria is considered essential information as defined in Section 5a (2) Unfair Competition Act (Gesetz gegen unlauteren Wettbewerb, UWG). According to the court, consumers have significant interest in familiarizing themselves with the content of the certification mark in order to make an informed purchase decision for or against a product. The court further points out that third-party certificates play a significant role in consumers’ decisions.

Given this, use of a certification mark which is targeted at consumers without providing a reference is considered “misleading by omission” as defined in Section 5a (2) UWG. In case of violations, manufacturers must expect written warnings or claims for damages.

On top of the above verdict, the Oldenburg Higher Regional Court (Oberlandesgericht, OLG) ruled in its verdict 2016 6 U 64/15 of July 31 that these references must be clearly legible. The OLG does not define a minimum font size, but provides for a case-by-case assessment and judgement of the overall impression.

Manufacturers and retailers must be especially careful when they use certification marks on packaging, any type of advertising materials, or the Internet. TÜV SÜD urgently recommends the use of only the new TÜV SÜD certification marks with Internet link for consumer products in the future.

Certificate explorer function

The updated TÜV SÜD certification marks now include additional short texts plus the link “tuev-sued.de/ps-zert” or “tuv-sud.com/ps-cert” in the English version, which is the reference required by BGH. This link redirects users to a public database of TÜV SÜD certificates containing detailed information about the certification marks and services. Short profiles of the certification marks provide information about both the content of the certification marks and that of certificates issued by TÜV SÜD, presented in a user-friendly way. An easy-to-use search function ensures that users can call up this information quickly and directly.

 

Disclaimer
Please note that ultimate responsibility for correct use of certification marks rests with the certificate holders. Unfortunately, TÜV SÜD cannot issue any warranty that the above measures will ensure 100% compliance with the current requirements of case law regarding advertising with certification marks. Please regard TÜV SÜD’s recommendations as a customer Service.

 

Services rund um die aktuellen Prüfzeichen

Certificate Explorer
Download Center
Information Brochure

E-ssentials MedDev Team

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