Commercializing in vitro diagnostic (IVD) devices in the European Union (EU) requires CE marking demonstrating compliance with the IVD regulations. The CE marking indicates that the legal manufacturer has assessed the device and it meets the General Safety and Performance Requirements under the IVDR 2017/746. The legal manufacturer will verify the conformity with all relevant EU requirements and must state as much in their EU Declaration of Conformity (DoC). Further, higher-risk devices (Class A sterile, B, C and D IVD devices under the IVDR) require independent assessment and certification by a Notified Body. This results in a CE marking certificate issued by the Notified Body confirming compliance of the manufacturer’s Quality Management System (QMS) and Technical Documentation with EU regulations.
The European CE IVD approval process explained
The chart illustrates the CE marking certification process per device classification and is available for download in the Regulatory Affairs Management Suite (RAMS). Only a condensed overview of the main steps for certification is provided here.
Appoint a qualified Person Responsible for Regulatory Compliance trained in the IVDR and determine the classification of your IVD device according to the classification rules of the IVDR.
Implement a QMS in accordance with the IVDR. Most companies apply the EN ISO 13485 standard to achieve compliance. Your QMS must include performance evaluation, post-market surveillance and post-market performance follow-up plans.
Prepare the Technical Documentation in accordance with Annex II and III of the IVDR.
Appoint an Authorized Representative (EC REP) in the EU and obtain a Single Registration Number (SRN) from the regulators via EUDAMED.
For all IVD devices except Class A (non-sterile), your QMS and Technical Documentation must undergo an audit with a Notified Body, an independent third-party conformity assessment body designated by European national authorities to carry out audits on medical device companies and products within the meaning of applicable EU legislation.
For Class A (non-sterile) IVD devices, there is no Notified Body intervention.
For all devices except Class A (non-sterile), you will receive a European Community (EC) CE marking certificate for your device and an ISO 13485 certificate for your facility following the successful completion of your Notified Body audit.
Prepare a DoC, a legally binding document prepared by the manufacturer stating that the device complies with the applicable European requirements, in accordance with Annex IV of the IVDR. You may now affix the CE marking.
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This is a condensed version of the steps outlined in the chart. You can obtain a detailed process chart and market reports for the EU IVDR when you create your complementary Regulatory Affairs Management Suite (RAMS) account. Get your first chart for free when you create a RAMS account.