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Clinical evaluation according to Regulation (EU) 2017/745 and the current European guidelines
A Clinical Evaluation Report (CER) is required for all medical devices of classes I to III and implantable devices. Since June 2016, the revision 4 of the guideline MEDDEV 2.7/1 has set higher requirements for performing a clinical evaluation. The Regulation (EU) 2017/745, published in June 2017, has implemented these requirements, which are now legally binding, and added further specifications, such as the preparation of a separated Clinical Evaluation Plan (CEP). Since May 26th, 2021, the MEDDEV 2.7/1 is allegedly no longer be valid, as it references the Directive 93/42/EEC. However, the Medical Device Coordination Group (MDCG) has published several guidance documents which continue to refer to certain chapters of the MEDDEV guideline.
Consequently, when performing a clinical evaluation, it is important to consider not only the Regulation (EU) 2017/745, but also the content of the European guidance documents and the MEDDEV guideline.
Under the Regulation (EU) 2017/745, the clinical evaluation shall 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 parties. In addition, an equivalent assessment became more difficult, a post-marketing clinical follow-up activities have to be planned and both the state of the art of the device and the scientific validity of the clinical data are being more critically assessed.
Join our seminar to expand your knowledge on the key regulatory requirements of the Regulation (EU) 2017/745, the relevant MDCG guidance documents and the MEDDEV 2.7/1 Revision 4. Take advantage of this seminar to prepare yourself to evaluate clinical data, fulfil the legal and normative requirements and put them effectively into practice. By the end of the course, you will be able to successfully update and prepare new regulatory-compliant CEPs and CERs.
Clinical Evaluation :
- Regulatory requirements according to:
- Regulation (EU) 2017/745
- Relevant MDCG guidance documents
- MEDDEV 2.7/1 Revision 4 requirements
- Structure and preparation of a CEP and a CER
- Relationship between a clinical evaluation and the technical documentation
- Systematic literature search in Pubmed and Embase
- Analysis of clinical experience data after CE mark
- Post-market clinical follow-up requirements
Target Group
- Medical device manufacturers
- Authors and reviewers of clinical evaluation reports
- Clinical Affairs Manager
- Regulatory Affairs Manager
- Engineers in the medical device industry
Training Goal
The seminar will give the participants an overview of the requirements of the Regulation (EU) 2017/745, the relevant MDCG guidance documents and the MEDDEV 2.7/1 Revision 4 guideline. Participants will learn how to prepare and structure a CEP and a CER, 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
Buchung
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