The letters ` C E` mean different things to different people, Chief Executive (I wish), Church of England or the element Cerium. In healthcare, we should know the acronym as “Conformité Européenne” or the CE mark on any electronic or electric gadget. It is a guarantee from the manufacturer that the product meets all the safety (and environmental protection) requirements of the European Union. Of relevance to us particularly, because it is mandatory for manufacturers of medical Devices to meet all the requirements before they can sell their products in any of the countries in Europe.
CE marking ensures the free movement of products that conform to the legislation within the European market and is a key indicator of a product’s compliance with EU legislation. By affixing the CE marking on a product, a manufacturer is declaring, on his sole responsibility, conformity with all of the legal requirements to achieve CE marking and therefore ensuring validity for that product to be sold throughout the EEA, the 27 member states of the EU and European Free Trade Association countries – Iceland, Norway, Liechtenstein and Turkey.
OK, that`s the official stuff! However, as always, it`s not all plain sailing and things may not be as they appear. That`s because some people cheat. `Gasp`, I hear collectively, but I can assure you that it happens, some CE Marks on Electronic Goods can be fake. Like everything else, the CE mark is misused and therefore not all products bearing the letters C and E can be considered safe. There are reports that some products made in China carry the CE mark but here CE stands for “China Export” (meaning the product is exported from China). A while ago I found one myself and it`s discomforting. Fortunately, this one was at home and not in the surgery.
Luckily, the lettering style and the spacing between the two letters in the “China Export” logo is a bit different, so it is not hard to spot the fake CE mark. The letters in the original CE mark are like two semi-circles of similar radius but one square bigger and, when drawn completely, they meet each other. The best test is get a pencil and just continue the two incomplete circles, the two letters should interlock. Also, the logo has to be at least 5mm high, unless the item itself is less.
Using a fake device could fail an inspection and could invalidate your insurance, have fun checking!
