Medical Device CE Marking

CE marking stands for "Conformite Europeenne", which means "European Conformity". CE Marking is also called sometimes "CE Mark”. It is compulsory to have this permit for many products to be sold in the European Economic Area (EEA). Sometimes CE Marking is also known as the "Passport to Europe", for the reason that without this credential the any product cannot enter into the European market. 

The CE mark is acknowledged by consumers everywhere as a symbol of quality and safety. Not only is it necessary in Europe, but also it can actually help to sell your product.

There are nearly 20 groups of product that entail the CE mark to be export to the Europe. Some of these are appliance which makes use of electrical equipment, gas, boats, explosives, medical devices, hot water boilers, machinery, radio, scale, telecommunications equipment, construction products, pressure equipment, toys and personal protective equipment. It’s not a complete list. If you search on-line there you can find further complete and detailed lists.

Now it’s obvious that the CE marking is compulsory for lots of electronic product and category of different products. There are lots of directives and regulations needed for certification. A European authorized representative can be exceptionally helpful in determining about the need of your product and they know how to support you with the procedure and paperwork.

There are three European CE mark Directives that specifically apply to medical devices manufacturers: 

• The Medical Devices Directive (MDD) apply to all general medical devices that are not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive 
• The In Vitro Diagnostics Directive (IVDD) applies to all devices and kits used away from the patient to make a diagnosis of patient medical conditions.
• The Active Implantable Medical Devices Directive (AIMDD) applies to all active devices and related accessories intended to be permanently implanted in humans

Depending on the individual case, every Medical Device manufacturer have to choose their own and most appropriate conformity module which address all its particular business needs and product categories.

CE marking is very important to put up products for sale in the EU. Find out how to get this credential here: http://www.meddevices.net