Medical Device CE Marking

The CE marking stands for "Conformite Europeenne", which means "European Conformity". CE Marking, is also called sometimes "CE Mark" or "CE-Marking. It is compulsory to have this permit

for many products to be sold in the European Economic Area (EEA). Sometimes it is referred to as the "Passport to Europe", because without this credential the any products cannot enter 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 twenty groups of products that entail the CE mark to be exported to the Europe. Some of these are appliance which makes use of electrical equipment, gas, explosives, machinery, medical devices, hot water boilers, construction products, radio, scale, and telecommunications equipment, pressure equipment, boats, personal protective equipment and toys. It’s not a complete list. If you search on-line there you can find further complete and detailed lists.



Now it’s clear that the CE mark is compulsory for many products and categories of different products. There are many directives and regulations needed for certification. An european authorised 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 marking 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(s) which address(es) all its particular business needs and product categories.

Certificates of free sale can only be issued where proof of manufacture is provided for the products concerned and the manufacturer, authorised representative or legal manufacturer is located in Ireland and if applicable, is certified to manufacture products with a CE mark.



Med Devices provides clinical research organisation services and clinical trial management services. We offer innovative service from planning to market authorization to our customers in pharmaceutical, biotechnology and medical device industry.



CE marks are very important in order to put up for sale in the EU. Learn how to get this credential here: http://www.meddevices.net.