target group
In vitro diagnostics manufacturers, particularly management, boards and executives. Employees in quality management, product development and management as well as regulatory affairs. Responsible person according to Article 15 IVDR, EU representatives and importers.
content
After a five-year transition phase, the European regulation for in vitro diagnostics (IVDR) will be mandatory for in vitro diagnostics manufacturers and economic operators in the EU from May 26, 2022 - this affects the placing on the market, the use and the market surveillance. This means massive changes with far-reaching consequences and challenges for IVD manufacturers. The new compact course gives the participants an overview of the IVDR, the essential changes from the IVDD to the IVDR and the legal requirements over the 5 days. The participants receive assistance with technical documentation, risk management and risk analysis, performance evaluation and clinical evidence.
Topic overview & dates
11/28/2022 Overview & Structure | Updated transition periods | Current Guidance Documents | definitions
11/29/2022 New classification system | Risk-based classification | Conformity assessment procedure | IVDR Annexes
11/30/2022 Requirements and documentation | Safety and performance requirements | Risk Management and Usability Engineering | traceability
12/01/2022 Clinical evidence | Performance Evaluation | Post-market surveillance | vigilance and market surveillance
12/02/2022 Technical documentation | Registration of economic operators and products | National requirements | Test
exam and graduation
After the course, the technical knowledge and skills acquired are tested in writing. After passing the exam, the participant receives a certificate issued by MedicalMountains GmbH.
Funding Opportunity
ESF funding is possible. More information can be found here .
KONTAKT:
Online
