CE Marking for Medical Devices

What is CE Marking?

CE marking is the mandatory conformity symbol that demonstrates a product’s compliance with the health, safety, and performance standards required within the European Union (EU). For medical devices, CE marking indicates that the product meets the Medical Device Regulation (MDR 2017/745) or In Vitro Diagnostic Regulation (IVDR 2017/746) standards and can be legally placed on the market in Germany and other EEA countries.

At Operon Strategist, we provide specialized regulatory support to guide manufacturers through the complete CE marking certification process for medical devices, ensuring market readiness and full regulatory compliance.

Why CE Marking is Mandatory for Medical Devices in Germany?

Germany is one of the largest and most highly regulated healthcare markets in Europe. To legally place a medical device on the German market, manufacturers must obtain CE certification for medical devices to demonstrate conformity with the applicable European standards.

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CE Marking confirms that a device:

Meets essential safety, performance, and quality benchmarks
Is supported by robust clinical, technical, and risk management documentation
Has undergone a conformity assessment under the supervision of a Notified Body (for higher-risk classes)
Complies with applicable post-market surveillance, vigilance, and reporting obligations

Once certified, the device gains access to Germany, the entire EU market, and the European Economic Area (EEA).

CE Marking Process for Medical Devices in Germany

Operon Strategist offers a structured, step-by-step service for CE marking registration and certification, customized for your device classification and risk profile.

1. Medical Device Classification

Devices are classified under MDR CE mark rules as Class I, Is, Im, Ir, IIa, IIb, III, or as CE IVD (In Vitro Diagnostics) under IVDR. The classification determines the conformity procedure and whether a Notified Body is required.

2. Technical Documentation Preparation

Our team prepares comprehensive technical files for CE medical devices, including:

Device description, intended use, and specifications
General Safety and Performance Requirements (GSPR) checklist
Design, manufacturing Facility, and risk management documentation (ISO 14971 compliant)
Clinical Evaluation Report (CER) or Performance Evaluation Report (PER)
Labeling, IFU, and UDI assignment
Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) procedures
CE IVD certification documentation for diagnostic devices

3. Notified Body Submission and Assessment

For higher-risk devices, Operon Strategist facilitates Notified Body selection, application management, audit preparation, and regulatory communications.

4. Quality Management System Compliance

A certified ISO 13485 QMS is mandatory for CE certification for medical devices, ensuring consistent product safety and performance.

5. EU Declaration of Conformity and CE Marking

Following a successful conformity assessment, manufacturers issue an EU Declaration of Conformity before applying the CE mark and placing the device on the European market.