Clinical Evaluation Procedure

Clinical Evaluation Procedure

Have you developed a Clinical Evaluation Procedure or Report SOP in compliance with present Notified Body requirements?

If YES, Please answer below.

  1. Which Regulation, Guideline or Standard you followed for the preparation of procedure/sop?
  2. When were the last updates made?
  3. Did your Notified Body make any serious remarks on your CER related procedures, SOP or Protocol?

Clinical Evaluation Report SOP to be made in line with the following requirements.

Requirements of Clinical Evaluation Procedure as per EN ISO 13485:2016.

ISO 13485 Clause 3.3 Clinical Evaluation assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer.

ISO 13485 clause 7.3.7 design and development validation, the organization shall perform a clinical evaluation of medical device in accordance with applicable regulatory requirements.

Requirements of Clinical Evaluation Procedure as per MDD 93/42/EEC.

As per Annex X, to establish conformity with the essential requirements concerning the characteristics and performance of the medical devices, a Clinical Evaluation Report shall be written and completed with relevant scientific literatures currently available based on the intended purposes and techniques associated with the medical devices and its use.

Requirements of Clinical Evaluation Report SOP as per MDR 2017/745 released April 2017

As per Article 5, section 3 of Placing on the Market and putting into service, manufacturer must demonstrate the conformity with the general safety and performance requirements of the medical devices and shall include a clinical evaluation in accordance with Article 61.

As per article 10, section 3 of General Obligation, manufacturer shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF.

As per article 32, section 2 of Summary of Safety and Clinical Performance, shall summarize safety and clinical performance with at least the aspects of the summary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up.

As per article 61 on Clinical Evaluation, shall plan, conduct and document in detail throughout the lifecycle of medical devices in accordance with this article and part A of Annex XIV and shall be updated with the clinical data obtained from PMCF plan in accordance with Part B of Annex XIV and the post-market surveillance plan referred to in Article 84.

Clinical Evaluation Procedure

Additional Resources

  • Clinical Evaluation Report.
  • Frequently Asked Questions
  • Clinical Evaluation Rev 4.
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