Introduction to CE Marking

Before you can sell a medical device or IVD within Europe, you must place a CE Mark (CE Marking) on your product. The CE Mark is not a quality certification nor is it intended for consumers. It is used by the European Competent Authorities (National Ministries of Health) as a way to quickly determine whether your product has met all of the requirements of the Medical Device Directive 93/42/EEC, In Vitro Diagnostic Directive 98/79/EC or the Active Implantable Medical Device Directive 90/385/EEC.

1. The Medical Device Directive states that companies must: -

• Compile a Technical File with evidence of compliance to the Medical Device Directive (or the IVD/AIMD Directives)

• Receive a CE Mark (CE Marking) certificate from a Notified Body if medium or high risk device

• Appoint an Authorized Representative if you have no physical location in Europe

• Register their medical devices with the Competent Authorities

Only after these requirements are satisfied are allowed to place the CE Mark on your device.

2. Prinsip Mahir has helped medical device companies with CE compliance. Our services include: -

• Technical file compilation and review

• Verification of Essential Requirements

• Product classification and identification of applicable CE Marking standards

• Implementation and maintenance of ISO 13485 quality systems

• Product labeling and packaging review

• Risk assessment and management (ISO 14971)

• Development of Vigilance Procedures and Post Market Surveillance

• Authorized Representation for Europe

3. Our quality systems meet European, US, Canadian and Australian requirements for device exportation to oversea

If you currently have no quality system in place, we will develop and implement an ISO 13485 system on a fast track to get your company certified to sell and ship into Europe. Each system is customized for the manufacturer and will not only ensure compliance to the European Directives for Medical Devices (CE Marking), but also to the Canadian Medical Devices Regulations, United States FDA QSR and Australian TGA requirements at no additional cost!.