A. Vogel eye drops: clinically proven by Notified Body
Medical device advertisements often contain claims about the functioning of the product. The television commercial for A. Vogel Extra Intensive Eye Drops: "Softens your dry eyes. A. Vogel eye drops provides long-lasting wetting and relief." Is it allowed to make that claim? Complainant is far from satisfied with the eye drops. He submits a complaint to the Advertising Code Committee. Perhaps the eye drops help with dry eyes, but with very dry eyes "it really doesn't help".Vogel claims that the claims are correct. The product falls under the category 'Class IIa of medical devices'. This means that it has been officially admitted to the European market: its safety and operation have been assessed by a so-called 'notified body'.
The certification is evidenced by the CE marking with the registration number on the packaging of the eye drops.The KOAG/KAG also believes that the TVC is permitted: the text is in accordance with the claimed effect permitted by the Notified Body.The Chairman of the Advertising Code Committee agrees with A. Vogel. Proof of compliance with claims should generally be based on clinical data. The Chairman considered that the control and approval by a Notified Body should be taken into account in the assessment of the complaint about deception. A. Vogel was able to demonstrate that the Notified Body had specifically ruled that the eye drop recommended in the advertisement had claimed effect. That is why the President does not consider it necessary to provide further substantiation. The complaint is rejected. A. Vogel may continue to say that its eye drops soften dry eyes and provide long-lasting moisturisation and relief.
This is a fair and good course. When a Notified Body has assessed and approved a certain claim, further proof of the claim by the advertiser is not required. Of course, the text in the advertisement must be in accordance with the operation approved by the Notified Body. This is also in line with the assessment policy of the KOAG/KAG.
Ebba Hoogenraad