Simply click the provided links below for detailed information to the listed themes.
Medical Device Directive
- Authorized Representative – Why & When?
- Product notification requirements?
- Reporting INCIDENTs?
- Product recalls?
- Product removals – Competent Authorities?
- Info exchange – Competent Authorities?
- Clinical Study Notification?
- Free Movement of Product?
- Notified Body Mandate?
- Notified Body Designation?
- Application of Harmonized Standards?
- Conformity Assessment Options?
- II. Full Quality Assurance System?
- III. EC Type-Examination?
- IV. EC Verification?
- V. Production Quality Assurance?
- VI. Product Quality Assurance?
- VII. EC Declaration of Conformity?