Date20.01.2021 | 10:00 - 14:30
Locationonline

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How to fulfil the requirements of the Regulation (EU) 2017/745 and the current European guidelines?

According to the Regulation (EU) 2017/745, a Clinical Evaluation Report (CER) is required for all medical devices of class I to III. 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). In June 2021, the MEDDEV 2.7/1 will 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.

In this context, the clinical evaluation should focus 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 will become more difficult, a post-marketing clinical follow-up will have to be planned and both the state of the art of the device and the scientific validity of the clinical data will be 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 online seminar to prepare yourself to evaluate clinical data, fulfil the legal and normative requirements and put them effectively into practice.

Goal of the training

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.

Your advantages of online trainings

Our online seminars continue to offer you the opportunity to keep up to date with current topics in medical technology, despite travel restrictions.
During the live presentation online you can communicate directly with our speakers. In order to enable an optimal transfer of knowledge, this online seminar is designed for approx. 4.5 hours, so that we have enough time for your comments and questions. Furthermore, a small group of participants ensures an interesting exchange of experience among each other and with the speaker.

Technical requirements:

Participation in an online training course can be done via PC, tablet or even smartphone. The only requirements are an Internet connection and a standard Internet browser. No special software is required for the participants. A headset is certainly helpful to suppress background noise. An integrated loudspeaker and a microphone ensure an interactive exchange of information between the participants during the online seminar.

Services

The participation fee includes the seminar documents in electronic form and proof of participation. In addition, there will of course be an opportunity for the participants to exchange experiences and discuss with our experts.

Booking

Ticket Type Price Spaces
Standard-Ticket 249,00 € **

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