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Clinical Evaluation Report (CER) is a mandatory technical document for medical device manufacturers to demonstrate that a device is clinically safe and performs as intended. Under the Medical Devices Rules (MDR), 2017 in India and similar global standards like the EU MDR, it serves as the formal record of a continuous process to collect, appraise, and analyze clinical data.

Primary Uses of a CER

  • Regulatory Approval: You cannot get a manufacturing or import license from the CDSCO (in India) or a CE Mark (in Europe) without a CER. It is the “evidence file” that regulators review before letting you sell the device.
  • Risk-Benefit Analysis: It objectively weighs the medical benefits of the device against its potential risks (e.g., radiation, infection, or side effects).
  • Market Authorization for High-Risk Devices: For Class C and Class D devices (like heart stents or ventilators), the CER is the most scrutinized document in your technical file.
  • Claim Substantiation: If your marketing says “This thermometer is 99% accurate,” the CER must provide the clinical data that proves that specific claim.

A CER is not just a summary; it’s a systematic review of data from multiple sources:

1. Clinical Investigations: Results from clinical trials conducted on the device.

2. Scientific Literature: Information from the scientific literature regarding similar “predicate” devices that are already marketed.

3. Post-Market Surveillance (PMS): Data on the performance of the device since it was placed on the market (complaints, failures, or success stories).

4. Equivalence Data: Proof that your device is technically and biologically similar to one that is already proven safe.

We are medical device consultants and our focus areas are MDR, IVDR, GMP, CE Mark, UKCA Mark, FDA 510k, ISO 13485, and 21 CFR 820 compliance, and more.
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