Simply click the provided links below for detailed information to the listed themes.
In-Vitro Diagnostic Medical Device Directive
- Authorized Representative – Why & When?
- Product notification requirements?
- Reporting INCIDENTs?
- Product recalls?
- Product removals – Competent Authorities?
- Info exchange – Competent Authorities?
- Performance Evaluation Notification?
- Medical Devices with Energy Source?
- Mechanical and thermal risks?
- Self-testing diagnostics?
- Product Labelling and Instructions for Use?
- Notified Body Designation?
- Application of Harmonized Standards?
- Conformity Assessment Options?
- III. EC Declaration of Conformity?
- IV. Full Quality Assurance System?
- V. EC Type-Examination?
- VI. EC Verification?
- VII. Production Quality Assurance?