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CE Mark / MDD / IVDD / AIMDD

The European Community (EC) has implemented a system to protect the health of consumers and users of manufactured products. EC Directives and harmonized standards were created to ensure conformity to safety and quality standards throughout all the member states of the EC. The directives are voted into laws by the respective countries. If you do not comply with these laws, it is the equivalent to breaking federal law in the US. A review of your product's certification can be requested by customs, competitors, or because of an accident. If you want to export your products to anyone of the following countries:

Your products must comply with the applicable EC Directives, and bear a "CE Marking" as a mark of conformity and compliance. It is a requirement for selling devices within Europe and the European distributors will typically request the CE Marking before carrying your product.

Applying the Strategy

The CE Mark represents compliance with a specific device directive that can be achieved through self-assessment or a certification body depending upon the device classification. Following are the steps to CE Marking:

1. Properly classify the device
2. Determine the applicable harmonized standards and essential health and safety requirements
3. Plan self certification or Identify and choose a notified body
4. Determine and perform the appropriate conformity assessment procedure
5. Incorporate the requirements into the device/system design
6. Assemble the Technical File
7. Prepare the Declaration of Conformity
8. Affix the CE Marking

For medical devices, the European Community requires compliance with the three special directives (Medical Device Directive (MDD), In-Vitro Diagnostic Directive (IVDD) and the Active Implantable Medical Device Directive (AIMDD)) in order to put the CE Mark on your device. With the CE marking shown on your product or, if not possible, on the package, it can circulate freely throughout the member countries. CE certification will help you obtain authorizations, if required, for medical products for non-CE countries.

How QPS can help

The QPS team are experts at guiding our clients to CE Mark—providing a roadmap and assisting them through the entire process of securing their CE Mark. Our services include:

• Device Classification
• Preparation of Technical File & Process
• Determination of Certifying Body
• Assistance in ISO Certification (as needed)

Our fast-track approach will save time and resources, decreasing your time to market. We expedite the process and minimize the costs involved by managing the process steps with you, keeping you informed all along the way. We are well versed in working with certification companies to meet the needs of our clients. QPS takes pride in its attention to detail and ability to provide consistent, quality service to help its clients get what they want, and provide a valuable service at the same time.

Please contact QPS to help you obtain CE Marking quickly and at a reasonable cost!