How to Prepare Clinical Evaluation Report (CER) under EU MDR 2017/745

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How to Prepare Clinical Evaluation Report (CER) under EU MDR 2017/745

The clinical evaluation of medical devices is a procedure for demonstrating the safety and efficacy of the devices. The documentation of the clinical evaluation process is called a Clinical Evaluation Report (CER). The CER holds a significant position when placing or distributing medical devices in the European Union (EU). The report aims to establish the device’s intended benefits for users when weighed against the associated risks.

Deep Diving into Periodic Safety Update Reports (PSUR) of EU MDR and EU IVDR

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Deep Diving into Periodic Safety Update Reports (PSUR) of EU MDR and EU IVDR

The establishment of European Union Medical Devices Regulations (EU MDR) 2017/745 and In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/746 posed additional requirements. The significant aspect highlighted was implementing the Post-Market Surveillance system (PMS). Enabling PMS will ensure the devices' safety even after being launched in the market.

US FDA Approval Pathways for IVDs

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US FDA Approval Pathways for IVDs

In-Vitro diagnostics (IVD) are products that are reagents, instruments, or systems that can detect diseases or other conditions and monitor a person’s overall health to help cure, treat, or prevent diseases.

The classification of an IVD determines the appropriate premarket process for approval. The FDA classifies IVD products into Class I, II, or III based on the associated risk.

Classification