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Clinical Evaluation Report – Regulatory Requirements (Medical Device Regulation 2017/745 and MEDDEV 2.7/1 rev. 4)

According to the European Medical Device Directive (93/42/EEC), a clinical evaluation report (CER) is required for all medical devices of class I to III. The new revision 4 of the current MEDDEV 2.7/1 and the Medical Device Regulation (MDR 2017/45) were published in June 2016 and May 2017, respectively. The alterations made in this revision as well as in the new regulation for medical devices have clearly increased the requirements for the preparation of a CER.

Under the new requirements, a CER should focus not only on the safety and performance of the medical device, but also on the benefits and usability aspects for patients, users and third persons. Furthermore, both the state of the art of a device and the scientific validity of clinical data will be more critically assessed.

Join our seminar in order to expand your knowledge on the key regulatory requirements of the MDR 2017/45 and MEDDEV 2.7/1 Revision 4. We will show you how to evaluate clinical data as well as how to put the new regulatory requirements into practice. By the end of the course you will be able to successfully and smoothly update and prepare new regulatory compliant CERs.

Clinical Evaluation Report:

  • MEDDEV 2.7/1 Revision 4 requirements
  • Regulatory requirements for medical devices
  • Clinical data and clinical evidence
  • Relationship between a CER and the technical documentation
  • Structure and preparation of a CER
  • Systematic literature search in Pubmed and Embase
  • Analysis of clinical data experience after product launch
  • Post-market clinical follow-up requirements
Target Group
  • Medical device manufacturers
  • Authors and reviewers of clinical evaluation reports
  • Manager clinical affairs
  • Manager regulatory affairs
  • Engineers in the medical device industry
Training Goal

The seminar will give the participants an overview of the MEDDEV 2.7/1 Revision 4 and Medical Devices Regulation 2017/745 requirements. Participants will learn how to prepare and structure a clinical evaluation, including how to conduct a literature search in scientific databases such as Embase and Pubmed. The seminar content will be deepened through practical examples and an interactive workshop.

Services

The participation fee includes the seminar documents, meals and the participation certificate. Of course, there will also be an opportunity to exchange experiences with the participants and to discuss with our experts.

Language

English

Price

590 € excl. tax

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