3rd IVDR & Immunoassays Mini-Symposium
Future Diagnostics is proud to be organizing our third IVDR & Immunoassays Mini Symposium on Wednesday November 18th, 2020 from 9 am to 10.30 am during MEDICA. Register below to reserve your seat.
Surely you have heard about it: the IVDR, the new In Vitro Diagnostic Medical Devices Regulation. Published in May 2017, it replaces the In Vitro Diagnostic Medical Devices Directive (IVDD) and brings new requirements for manufacturers. Do you know how this affects you, and how you will make sure you are fully compliant by 2022?
The agenda will be available in due time.
With the IVDR we will see many changes in definitions, and it also has a wider scope. This means that products currently classified as an in vitro diagnostics device (IVDD), may require IVDR compliance. The IVDR also tightens the requirements for clinical evidence and conformity assessment. Technical documentation must contain the results and critical analyses of all design verification and validation tests – data must be collected in compliance with the harmonised standards and applicable Common Specifications.
Messe Düsseldorf, Germany
Location: Room 28 (entrance Süd, above Hall 3)
Wednesday November 18th, 2020: 9 am to 10.30 am
Free of Charge