Medical Technology
- Our supervision of medical technology
- New European Regulations for medical devices and IVDs
- Market authorisation
- Clinical research involving the use of medical devices
- Registration and deregistration of medical devices or IVD's
- Free sales certificates
- Requirements for labelling, instructions for use and language
- Role of notified body
- CE certificate suspended or withdrawn
- Supervision on products
- Supervision of post-market surveillance
- Vigilance: reporting incidents and corrective actions
- Inspection visits
- Online questionnaires
- Supervision of inducements
- Topics on medical products
- Essure
- Silicone breast implants
- Hypodermic needles
- Blood glucose meters
- eHealth
- Safety notices
Medicines
- Clinical trials (GCP)
- Rules for clinical trials
- How inspections are conducted
- Inspection results of clinical research
- Good Laboratory Practice (GLP)
- Purpose and principles of GLP
- How we conduct inspections
- GLP test facilities
- Pharmacovigilance (GVP)
- What we do
- Risk-based pharmacovigilance questionnaire
- Qualified Person for Pharmacovigilance
- Pharmacovigilance System Master File
- Medicines without marketing authorization