IVDR-Update-Training

Content and Objective of the Course

The marketing of in-vitro diagnostic medical devices (IVDs) in the EU has experienced significant changes with the publication of EU regulation 2017/746, often known as the in-vitro diagnostic medical device regulation, IVDR, in May 2017. All manufacturers of IVDs, sponsors, and trial sites are obliged to adjust to the new regulation due to the adaptation of the IVDR since May 2022.

The objective of this training is to give participants expertise in the administrative, legal, ethical, and scientific facets of clinical trials with in-vitro diagnostic medical devices. Our IVDR-Update-Training summarizes 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 flexibility, adaptability, and accessibility of this online training are its advantages.  Users can complete a training program at their own speed and location. Additionally, they have two months to access the training at any time. The online training is always up to date according to new regulations.

Instructions for Participants and General Conditions

The online training consists of two modules, each lasting approximately 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 approximately 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 approximately 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.