Hamburg, 28.04.2020, Christoph Petershagen
Die Europäische Kommission hat wieder neue Orientierungshilfen für Hersteller und Benannte Stellen bereitgestellt. Diese neuen Dokumente beschäftigen sich insbesondere mit der Klinischen Bewertung und der Klinischen Nachverfolgung nach dem Inverkehrbringen (PMCF). Folgende Dokumente stehen Ihnen nun zum Download bereit:
- MDCG 2020-5 Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies
- MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies
- MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies
- MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies
Sollten Sie Fragen zum Umgang mit der Klinischen Bewertung oder zu diesen Dokumenten haben sprechen Sie uns gerne an. Unsere Experten beraten Sie gerne.
New MDCG Documents for Clinical Evaluation
The European Commission has provided some new guidance documents for manufacturers and notified bodies. These documents especially deal with clinical evaluation and post-market clinical follow-up (PMCF). The following documents are available as a download:
- MDCG 2020-5 Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies
- MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies
- MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies
- MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies
Should you have any questions regarding the clinical evaluation or these documents feel free to contact us. Our experts are eager to consult you.