Commercializing medical devices in the European Union (EU) requires a CE marking demonstrating compliance with the medical device regulations. The CE marking indicates that the legal manufacturer has assessed the device and that it meets the General Safety and Performance Requirements under the MDR 2017/745. The legal manufacturer will verify the conformity with all relevant EU requirements and must state this in their EU Declaration of Conformity (DoC). Furthermore, higher-risk devices (Class I sterile, measuring or reusable surgical instruments, Class IIa, Class IIb and Class III devices under the MDR) require an independent assessment and certification by a Notified Body. This results in a CE marking certificate issued by the Notified Body confirming the compliance of the manufacturer’s Quality Management System (QMS) and Technical Documentation with EU regulations.
The European CE medical device 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 Person Responsible for Regulatory Compliance who is trained in the MDR and determine the classification of your device according to the classification rules of the MDR.
Implement a QMS in accordance with the MDR. Most companies apply the EN ISO 13485 standard to achieve compliance. Your QMS must include clinical evaluation, post-market surveillance (PMS) and post-market clinical follow-up (PMCF) plans.
Prepare the CE Technical Documentation per Annex II and III of the MDR.
Appoint an Authorized Representative (EC REP) in the EU and obtain a Single Registration Number (SRN) from the regulators via EUDAMED.
For all devices except Class I (self-certified), your QMS and Technical Documentation must be audited by 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 I (self-certified) devices, there is no Notified Body intervention.
For all devices except Class I (self-certified), you will be issued 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 in accordance with Annex IV of the MDR, a legally binding document prepared by the manufacturer stating that the device complies with the applicable European requirements. 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 MDR when you create your complementary Regulatory Affairs Management Suite (RAMS) account. Get your first chart for free when you create a RAMS account.