- News
- Topics
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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- CE certificate suspended or withdrawn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
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Medicines
- Clinical trials (GCP)
- Rules for clinical trials
- How clinical trials are monitored
- Inspection results of clinical research
- Production (GMP)
- GMP inspections and GMP certificates
- Notification of product defects and recalls
- Active pharmaceutical ingredients (APIs)
- Security features on medicinal products
- Distribution (GDP)
- GDP supervision
- Active pharmaceutical ingredients (APIs)
- Notification of an interruption on the market or a shortage
- Good Laboratory Practice (GLP)
- Purpose and principles of GLP
- How we conduct inspections
- GLP test facilities
- Pharmacovigilance (Phv)
- What we do
- Risk-based pharmacovigilance survey
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Integrated care
- General information
- Area-based supervision
- Supervision of specialist medical care at home for children
- Supervision of care networks in home environments for frail elderly people
- Supervision of infection prevention and regional cooperative networks antibiotic resistance
- Processing incident reports involving integrated care
- Collaboration with other supervisors
- Documents
- Who are we?