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IVD CE Marking
IVD CE Marking or other words In-Vitro Diagnostic Device CE Marking refers to the European certification process to qualify a device to be legally register and sell in European territory without any hurdles. The whole process is governed by the In Vitro Diagnostic Regulation 2017/746, which replaced the older IVD Directive 98/79/EC. In short IVD CE Marking confirms that an IVD device meets EU safety, performance, and quality standards.
As a trusted IVD CE Marking Service provider. I3CGLOBAL guides manufacturer and navigates the complexities of the EU IVD Regulation and gets access to the EU market soon.
Main Requirements for IVD CE Marking
IVDR Device Classification (Class A, B, C, D)
In Vitro Diagnostic Regulation (IVDR) 2017/746, IVD devices are classified based on the level of risk. Class A devices are considered low risk, such as specimen containers. Class B devices have moderate risk. Class C devices are higher risk and usually include tests used to detect infectious diseases. Class D devices are the highest risk category and include tests used for blood screening, such as HIV tests.
Quality Management System
IVD manufacturers must establish a MDQMS to control the design, manufacturing, and quality of the device. IVDR insists manufactures to follow EN ISO 13485:2016 to meet the compliance with IVDR 2017/746
Technical Documentation
Manufacturers applying for IVD CE Marking must prepare technical documentation file (TDF) to show that the device meets the requirements of IVDR. The TDF includes device description, intended use, design and manufacturing information, risk management, performance evaluation, analytical performance, stability information, labeling, and Instructions for Use (IFU).
Performance Evaluation
IVD CE Marking applicants must study about performance evaluation to demonstrate that the device reads and answer correctly. This kind of study and evaluation normally includes scientific validity, analytical performance, and clinical performance.
Notified Body Assessment
All IVD CE Mark applicants must submit TDF (Class B, C and D only ) to NB for review and IVD CE Certification
EU Authorized Representative
Manufacturers located outside the European Union must appoint an Authorized EU Representative. This representative communicates with EU authorities and ensures the manufacturer follows the required regulations.
Declaration of Conformity (DoC)
IVD CE Marking applicants must prepare and signs the EU Declaration of Conformity in controlled format and confirms that the device complies with 2017/746 rules and attach into TDF
🔴 Important Point – Major Challenge in IVD CE Marking
One of the biggest challenges IVD manufacturers face under the under IVD CE Marking is meeting the strict requirements for performance evaluation and technical documentation, especially for Class C and Class D IVD devices. These devices require strong scientific evidence, detailed analytical and clinical performance data, and thorough review by a Notified Body.
Many manufacturers find it difficult to collect the required clinical data, prepare compliant documentation, and manage the complex review process. We also observed many manufactures do not have the proper know how and what way to conduct theses studies in real time. As a result, expert regulatory consultants is often needed to successfully obtain IVD CE Marking .
Frequently Asked Questions
What is an IVD Device?
The IVD device is a device or instrument or a software used to examine samples taken from the human body, such as blood, urine, or tissue, to provide information about health conditions. Few simple examples are the following
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Blood glucose test kits
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COVID-19 diagnostic tests
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Pregnancy tests
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PCR diagnostic kits
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Hematology analyzers