How to Create Clinical Evaluation According to EU MDR 2017/745 Article 61 and Annex XIV

Attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system and your technical documentation. Your implementation needs smart ideas to reach the right level to pass the quality management audits and technical documentation audits and review by your notified body.

Why Should You Attend:

The medical device regulation EU MDR 745/2017 in the European Union has a lot of requirements. One key topic is the focus on the clinical data, “Clinical Evaluation-Process” and how this process is connected to other processes in the quality management system according to ISO 13485:2021 and EU MDR 2017/745. The understanding of the changes and how to implement the changes is essential to keep your certificates up to date and to keep the market entry open to EU, EEA, Switzerland and Turkey.

Learning Objectives:

• Introduction, who must apply the new EU MDR 745/2017 requirements
• Overview about the changes of the EU MDR 745/2017 regarding “clinical evaluation” of your products
• Explaining of each change
• Smart and fast ways to implement the changes in your technical documentation
• Fast track internal audit to approve the changes

Areas Covered in the Webinar:

How to define a “Clinical Evaluation-Process”?

How to create the new clinical evaluation for the Notified Body and the Competent Authorities?

How to gather the data input for the clinical evaluation?

How is the Clinical Evaluation-Process” connected to post market surveillance, customer feedback, complaints and vigilance?

Who Will Benefit:

• CEO’s, product manager, quality/regulatory/medical affairs manager, quality representatives of
• medical device manufacturers
• importer
• distributors
• dealers
• who work with European Union