MDR and Annex XIV: the Crucial Role of Clinical Evaluation Reports

Learn how to build an MDR compliant clinical evaluation process, the minimum content requirements of the CEP and their implications, the criteria for equivalency and differences with Meddev 2.7/1 Rev. 4 and the importance of post-market clinical follow-up (PMCF).

Join us!

May 19, 2022
9-10 a.m. CT

May 19, 2022

Annex XIV of the Medical Devices Regulation 2017/745 (MDR) requires Clinical Evaluation Reports (CER) and a Clinical Development Plan (CDP). Some manufacturers need more clarity in order to meet these new standards and may choose methods depending on whether they have an existing product in the market or are planning to introduce a new product under MDR.

This presentation outlines: 

  • How to build an MDR compliant clinical evaluation process
  • The minimum content requirements of the CEP and their implications 
  • The criteria for equivalency and differences with Meddev 2.7/1 Rev. 4
  • What is considered sufficient clinical evidence for legacy devices
  • The importance of post-market clinical follow-up (PMCF)

PRESENTERS

  • Rachel Paul
    Senior consultant, Quality and Regulatory Affairs
    Rachel Paul has over 13 years of experience in the medical device industry as well as international experience in high-risk device regulatory submissions and quality assurance requirements. Paul’s accomplishments include working on nine FDA 510(K) clearances, developing more than 10 EU Technical Files/Design Dossiers, writing more than 25 Clinical Evaluation Reports, implementing five quality systems to ISO 13485/CE Marking/FDA QSRs/CMDCAS, working on quality system gap assessment and improvements, auditing for compliance to multiple standards, conducting training to various international regulations, working on more than 30 global regulatory strategy analyses, and compiling and submitting numerous registration dossiers for international marketing authorization.