In-vitro diagnostic (IVD) medical devices

About the In-vitro Diagnostics (IVDs) Medical Devices training

The training on In-vitro Diagnostics (IVDs) for medical devices familiarizes you with the European In-Vitro Diagnostic Medical Device Regulation (IVDR). In-vitro diagnostics (IVDs) are diagnostic tests that examine samples taken from the human body, such as blood or urine, outside of the body. Examples of IVDs include blood glucose meters, pregnancy tests, and tests that indicate whether someone has a genetic disease.

Topics covered in this training include risk classification, assessment by Notified Bodies, quality management system and product requirements. It also delves into the relationship with and use of harmonized ISO standards, MEDDEVs (Medical Devices Documents) – working groups, and Global Harmonized Task Force documents (study groups). Additionally, you will learn about risk analysis, validation, clinical performance evidence, post-market surveillance, labeling, complaints, vigilance, and the recall process.

• The current European directive (98/79/EC IVDD) and recently published European regulation (IVDR: 2017/746/EU) for IVD Medical Devices, including the impact of amended classification rules
• The current requirements in the US for IVDs: 510(K) versus Premarket Approval (PMA) route
• The Canadian requirements and classification under ISO 13485 according to the Canadian Medical Device Regulation (CMDCAS) and future requirement of the Medical Device Single Audit Program (MDSAP)
• Strategic considerations and pathways to CE marking and/or FDA and ROW approvals
• Selection and interpretation of applicable standards and guidance documents: ISO standards specific to IVDs, MEDDEVs, and Global Harmonization Task Force (GHTF) documentation
• Establishing and maintaining technical/design dossiers according to the STED, including interpretations of regulatory essential requirements
• Choices regarding the establishment of a required quality management system
• Relationship of regulations with ISO 13485
• Required risk management processes (according to ISO 14971)
• Upcoming requirements for clinical performance evidence for IVDs
• Post-market surveillance requirements
• Required software validation, if applicable:
  • When a medical app is considered a medical device and what the requirements are

• The role of regulatory authorities (competent authorities, Notified Bodies):
  • Annual audits, unannounced audits
  • Selection of the Notified Body and collaboration
• Practical tips for implementing the required procedures within your company when bringing the product to different markets:
  • Handling complaints, vigilance, and recall actions
  • Performance evaluation requirements and post-market surveillance
  • Instructions for use, labeling, and meeting language requirements
  • Design/technical dossier including change control process
  • Critical supplier control