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CE-marking process for in vitro diagnostics under In Vitro Diagnostic Medical Device Regulation (IVDR)

The process of obtaining CE marking under IVDR can be complex, and a solid understanding of it is essential for successful market access in Europe. The diagram below illustrates the necessary steps to achieve CE marking for your IVD.

Determine the CLASSIFICATION of your device using Annex VIII of the IVDR Class A Class B Class C Class D Implement QUALITY MANAGEMENT SYSTEM (QMS) in accordance with IVDR Most companies apply the ISO 13485 standard to achieve QMS compliance. Prepare a TECHNICAL DOCUMENTATION which provides detailed information demonstrating compliance with the In Vitro Medical Device Regulation. Appoint an AUTHORISED REPRESENTATIVE (EC REP) located in Europe and qualified to handle regulatory issues. Place EC REP name and address on packaging. Register the manufacturer and the medical device in the EUDAMED database. As a result you will get the unique device identifier (UDI). Your QMS and Technical File or DESIGN DOSSIER must be audited by a Notified Body. A CE Certificate for your device will be issued upon successful completion of the Notified Body audit. Prepare a DECLARATION OF CONFORMITY, a legally binding document prepared by the manufacturer stating that the device is in compliance with the applicable Regulation. You may now affix the CE Marking. Conduct ongoing batch testing and forward resuls to your NB

In vitro diagnostic medical device classification

In Europe, in vitro medical devices are classified following the rules outlined in Annex VIII of the In Vitro Diagnostic Medical Devices Regulation. This means that the classification of a product, which may fall under a particular class in China, Brazil, USA, or Canada, could differ when it enters the European market.

Technical documentation

Technical documentation forms a cornerstone requirement for in vitro diagnostics, encompassing all classes, and holds significant importance within the CE-marking process under the In Vitro Diagnostic Medical Device Regulation. This documentation acts as a comprehensive repository, capturing the medical device's design, development, manufacturing, and performance data, ensuring its adherence to the MDR's requirements for safety and performance.

Quality system compliance

The Quality Management System (QMS) plays a pivotal role in the CE-marking process under IVDR. It serves as a framework that guides IVD manufacturers in upholding the highest quality standards at every stage of the device's lifecycle - from initial design and development to production, distribution, and post-market activities.

EU Authorised Representative

For companies without a physical presence in the European Union, appointing an Authorised Representative (EC REP) is an essential requirement. While a local distributor can fulfill this role, opting for a professional and independent EC REP brings numerous advantages.

Audit and certification support

Manufacturers pursuing CE certification for Class B or higher class devices undergo rigorous audits conducted by Notified Bodies.

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