2026-03-21 2026-03-21 , online online, 690 € zzgl. MwSt. Clinical Trials for Medical Devices in the EU

This course provides an overview of the regulatory framework and key requirements for planning, submitting and conducting clinical investigations of medical devices in the EU. It covers practical aspects from study preparation to close out, including documentation, monitoring, safety obligations and reporting requirements.

Themen

EU regulatory framework and study types
Submission, approvals, registration and site requirements
Study conduct, data, monitoring and safety
Essential documentation and initiation processes
Close-out, inspections and reporting duties

Who should attend

This seminar is designed for professionals involved in planning, submitting or managing clinical investigations of medical devices in the EU. It is suitable for sponsor representatives, clinical project managers, regulatory affairs specialists, study coordinators and quality managers.

No prior in depth knowledge is required; basic familiarity with clinical research processes is helpful but not essential.

Ziel der Veranstaltung

This seminar provides a concise and practice oriented overview of the regulatory requirements for clinical investigations of medical devices in the EU. Participants gain a structured understanding of approval pathways, study conduct and post study obligations under MDR, MPDG and ISO 14155. The programme supports professionals in planning, submitting and managing clinical investigations efficiently and in compliance.

Teilnehmerkreis

Understanding of EU regulatory requirements for clinical investigations
Practical guidance for preparing and submitting applications
Insight into study conduct, monitoring and safety reporting
Overview of close out, inspections and documentation requirements