Content and Objective of the Course

With the release of the EU regulation 2017/746 (in-vitro diagnostic medical device regulation, IVDR) in May 2017 the marketing of in-vitro diagnosic medical devices (IVD's) in the EU undergo major changes. With the full application of the IVDR in May 2022 all manufacturers of IVD's have to be adapted to the new regulation and sponsors as well as trial sites have to be prepared.

The objective of this training is to provide competence in legal, ethical, and administrative as well as scientific aspects of a clinical trial with in-vitro diagnostic medical devices. Our IVDR-Update-Training summarises the key changes with the application of the IVDR and the ISO 20916:2019 and provides you with all recent regulatory updates in the EU.

The advantage of this online training is the extendibility, accessibility, and suitability. Users can proceed through a training program at their own pace and at their own place. They can also access the training at any time within 2 months. The online training is always up-to-date.

Instructions for participants and general conditions

The online training consists of two modules, each lasting approx. 60 minutes:

1. Regulatory aspects of In-vitro Diagnostic Medical Device Regulation (IVDR 2017/746)
2. Clinical Operational Aspects of ISO 20916:2019

The modules are continuously updated to the most current legal regulations and trends (no liability assumed). Each module consists of a presentation of approx. 45 minutes followed by a multiple choice test which must be passed. The test consists of 15 questions generated randomly from a pool of 40 questions and takes approx. 15-20 minutes. 80% of the questions need to be answered correctly to pass. After each failed test, the attendees receive a new set of 15 random questions. Three test repeats are possible after which the attendee must start from the beginning. The individual modules can only be processed in order. After completing all modules and tests, the attendees can download and print the training certificate independently. The certificate contains all topics required by the Ethics Committee and competent authorities to prove the qualification of clinical research staff according to ISO 20916.

All training modules within a training course must be completed within two months. If the two-month period has expired and the two questionnaires have not been answered correctly, the online training must be restarted.