The Birth of the CE Marking

The CE marking originated indirectly from a dispute over the French liqueur Crème de cassis. In 1979, Germany blocked its import because its alcohol content was lower than the national requirement for liqueurs. The importer appealed to the European Court of Justice, which ruled that such restrictions could not justify obstacles to the free movement of goods. The famous Cassis de Dijon judgment thus paved the way for dismantling many protectionist barriers. This led, in 1985, to the shift from the “Old Approach,” where Directives covered every technical detail, to the “New Approach”: Directives and Regulations define only essential and mandatory requirements, while harmonized standards provide voluntary technical specifications. The CE marking was formally introduced in 1993 through Decision 93/465/EEC as a “passport” enabling the free circulation of products within the European Economic Area. The symbol, designed by Arthur Eisenmenger, certifies conformity with EU safety, health, and environmental requirements and applies to new or imported products, including second‑hand ones. There is also the myth of the “China Export” logo, though it is unfounded. As an exercise, one can check CE markings on everyday items and consider which Regulations they must comply with.

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Welcome to Compliance Espresso, the podcast where we break down European medical device legislation with clarity, rigor, and just a hint of irony. Short episodes designed to give you reliable guidance in just a few minutes, like a good cup of coffee. I'm Nicola Focci. I've been working in the medical device field for over 25 years, including 8 years inside notified bodies. Let's get started. Would you believe it? The CE marking was born from a legal dispute about a liquor. Before you make the obvious jokes about the effects of alcohol and the terrible decisions that can be made under its influence, listen to this. It was 1979, the year Iran officially became an Islamic Republic and the Soviet Union invaded Afghanistan, but also the year Sony released the Walkman as Malpox was declared globally eradicated by the Worth Earth Organization. In Germany, an importer began, or rather tried to begin, selling a liqueur called crème de cassis. Crème de cassis is a red, sweet liqueur made from black currants. It's a speciality of Burgundy, but it's also produced in other French cities as well as in Luxembourg and Quebec. It happened that the German Alcohol Monopoly Authority blocked the importation of the crème de cassis into Germany because its alcohol content to 20% was below the minimum required by the German law for liqueurs, at least 25%. The German importer turned to the European Court of Justice, arguing that this measure violated the free movement of goods within the community. The Court of Justice sided with the importer and ruled against the German administrative body, stating that the requirements relating to the minimum alcohol content of alcoholic beverages do not pursue an objective of general interest capable of taking precedence over the needs of the free movement of goods. This ruling, known historically as Cremde Cassi de Jon decision, was a fundamental step towards dismantling protectionist barriers. Following the ruling, the so-called old approach, in which each directive covered all the aspects of a product, including technical specification, was abandoned in 1985 in favor of the two-level new approach. First level is EU directives and regulations. They focus only on the essential performance and functional requirements that products placed on the market must meet in order to benefit from free circulations within European Union. They do not specify manufacturing details. Directives and regulations are mandatory. Second level is harmonized standards. These contain the technical specifications to be applied to a given product so that it meets the essential requirements set out in the directives. Harmonized standards are voluntary. C marking was formally introduced by the Council Decision 93465 EEC of 22 July 1993. This decision established the modulus and conformity assessment procedures required to affix the marking to products with a specific aim of making it a commercial passport enabling the free circulation of products in the European economic area. The CE symbol applies to a wide range of products such as procedural vessels, machinery, toys, lifts, pyrotechnic articles and of course medical devices. The symbol standing for Conformity European and featuring precisely defined proportion was designed by German graphic artist Arthur Eisenmanger, the same creator of the Euro logo. Since then, it has certified that the product meets the essential safety, earth and environmental protection requirements laid down by the EU law. The C marking requirement applies to all methods of placing products on the market and all types of sales, including e-commerce, whenever the website targets the EU market. It applies to finishing products and to newly manufactured or second-hand products if imported. The last point is particularly interesting. I remember when I first joined a gym in my town and was surprised to find that the treadmill, properly C marked, had a control panel with instruction in German. Shouldn't it be available in the language of the country where it's marketed? Almost certainly, it was used a used product originally from Germany and not imported. Had it arrived, say, from China, then yes, the control panel would have needed to be translated. Regarding the C mark, there's a myth claiming that the Chinese manufacturers fraudently apply it, saying it stands for China Export. But it seems this is simply a myth without real foundation. As a little regulatory game, try finding a C marking on a product you have at home and ask yourself which regulation it should comply with. This is one of those cases where artificial intelligence comes in handy. I asked which European regulations a simple electric toathbrush must comply with, and this was the answer: LVD EMC ROHS. Nice shot, AI. You've just listened to an episode of Compliance Espresso. The next episode will be out in two weeks. If you have comments or suggestions, feel free to write me at nicola at foci.it. Thank you for listening.