TEAM-NB Position Papers
TEAM-NB (Team of Notified Bodies) is the European association of medical device notified bodies.
Clinical Evaluation
| Topic | Description |
|---|---|
| Clinical Evaluation | Practical guidance on CER requirements under MDR |
| PMCF | Post-Market Clinical Follow-up requirements |
| Equivalence | Demonstrating equivalence under MDR |
Technical Documentation
| Topic | Description |
|---|---|
| Technical Documentation | Structure and content requirements |
| SSCP | Summary of Safety and Clinical Performance |
Software & AI
| Topic | Description |
|---|---|
| SaMD | Software as a Medical Device classification |
| AI/ML | Artificial Intelligence in medical devices |
Transitional Provisions
| Topic | Description |
|---|---|
| Legacy Devices | Transitional provisions under MDR |
| Certificates | Certificate validity and renewal |
INFO
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