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Technical documentation according to Regulation (EU) 2017/745 on medical devices

The European Parliament and Council have agreed on the delay of the EU-MDR. The date of application has been shifted for another year to 26. May 2021. Nonetheless this is only borrowed time and especially for class I medical device manufacturers it is still a challenging tasks to meet all requirements until the revised date of application. There are no additional exemptions or grace periods available for these class I manufacturers. One of the key elements and major tasks is the compilation and maintenance of the technical documentation in accordance with annexes II and III of the EU-MDR. In this keynote we are going to present you the required updates, typical deficiencies and nonconformities we have experienced in our projects and discussions with notified bodies and manufacturers and we provide clear statements and recommendations how to address these gaps.

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