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Clinical Evaluation Procedure

Clinical Evaluation Procedure guides the QA/RA professionals to conduct medical device clinical evaluation in-line with MDR and Meddev 2.7/1 Rev.4.

US FDA DMF

Clinical Evaluation Procedure & Templates

Clinical Evaluation Procedure explains the entire clinical evaluation process beginning from the scope and plan through the clinical evaluation report (CER). The clinical evaluation procedure is compliant to EN ISO 13485:2016, MDD, MDR 2017/745 and Meddev 2.7/1 Rev.4.

 

The Clinical Evaluation Procedure gives detailed instructions on:

  • defining the scope and plan of a clinical evaluation;
  • identification of pertinent data;
  • literature search and reviews;
  • appraisal of pertinent data;
  • analysis of clinical data;
  • generating a Clinical Evaluation Report (CER).

Clinical Evaluation Procedure as per EN ISO 13485:2016.

Clause 3.3 states that clinical evaluation assessment and analysis of clinical data pertaining to a medical device mandates to verify the clinical safety and performance of the device when used as intended by the manufacturer.

Clause 7.3.7 design and development validation state that the organization should perform a clinical evaluation of medical devices in accordance with applicable regulatory requirements.

Clinical Evaluation Procedure as per MDD.

As per Annex X, to establish compliance with the essential requirements concerning the characteristics and performance of the medical devices, an SOP for Clinical Evaluation Report should be written and completed with pertinent scientific literature currently available based on the intended purposes and techniques associated with the medical devices and its use.

Clinical Evaluation Report as per MDR 2017/745

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

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

As per article 61 on Clinical Evaluation, the manufacturer ought to plan, conduct, and document clinical evaluation in detail throughout the life cycle of medical devices in accordance with this article and part A of Annex XIV and should 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 and Templates

Our team of technical experts and managers worked for many months and has developed a set of documents (procedures and templates) in-line with MDR article 61 and MEDDEV 2.7/1 rev 4. We started selling these documents from Dec 2019 via online.  These editable and easy customizable word files are good for those who do not have time to spend time on guidance.

What are the major Objective Evidences generated as part of CER

  • Clinical Evaluation Plan
  • Clinical Evaluation Report
  • Data Retrieved from Manufacturer
  • Literature Search and Review Plan
  • Literature Search and Review Report
  • Demonstration of Equivalence
  • Clinical Data Appraisal Plan
  • Appraisal of Pertinent Data
  • Analysis of Clinical Data