CE Marking For Medical Devices

CE Marking For Medical Devices

The CE marking is required for many products. It demonstrates that the product is assessed before being placed on the market and meets EU safety, health and environmental protection requirements. CE marking is a legal requirement for medical devices intended for sale in Europe. There are three European Directives that specifically apply to medical devices manufacturers:

• The Medical Devices Directive (MDD) applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive.

• The Active Implantable Medical Devices Directive (AIMDD) applies to all active devices and related accessories intended to be permanently implanted in humans.

• The In Vitro Diagnostics Directive (IVDD) applies to all devices and kits used away from the patient to make a diagnosis of patient’s medical conditions.

Products with CE Mark on it make trade easier and cheaper between EU countries. It means that a manufacturer claims their product conforms to legal requirements for health and safety define in EU directives. On the other hand, often customers will look for CE marking on a product as an indication of conformance to standards.

DQS is one of the Notified Body recognize by EU so give us a call today if you required CE Marking solutions.

ce_markingRegional MD of DQS Mr. Danny Ng (R) hands over the CE Mark certificates to Biovic Sdn. Bhd.’s Chief Technology Officer,  Mr. Tarun Edwin (L), and Mr. Suchit Jacob (M) Director of Business Development