content
After a five-year transition phase, the European regulation for in-vitro diagnostics (IVDR) is mandatory for in-vitro diagnostics manufacturers and economic operators in the EU from May 26, 2022 - this applies to placing on the market, use and 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.
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.
Topic overview & dates
14.11.2023 Overview of the In Vitro Diagnostics Ordinance | Overview of the structure of the IVDR | Updated transition periods according to Regulation (EU) 2022/112 | Important Definitions | Current guidance documents of the Medical Device Coordination Group (MDCG) | Obligations and innovations for economic operators | Manufacturers, agents, importers and distributors
11/15/2023 New classification system for in-vitro diagnostics | Risk-based classification (class A, B, C and D), including examples - see MDCG | Conformity assessment procedure in accordance with the In Vitro Diagnostics Ordinance | IVDR Annexes – IX, X, XI | role of the notified body
11/21/2023 Requirements for IVD products and their documentation - Part 1 | Concept of Essential Safety and Performance Requirements (GSPR) | Risk Management and Usability Engineering | Traceability requirements (Unique Device Identification (UDI) and EUDAMED)
11/22/2023 Requirements for IVD products and their documentation - Part 2 | Clinical evidence, performance evaluation including analytical and clinical performance studies | Post Market Surveillance (PMS)/Post Market Performance Follow-up (PMPF) | vigilance and market surveillance
11/23/2023 Requirements for IVD products and their documentation - Part 3 | Technical Documentation | Registration of economic operators and products in EUDAMED | National requirements of the MPDG for Germany | test
exam and graduation
After the course, the technical knowledge and skills acquired are tested in writing. Please register for the exam via our appointment calendar . 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
