2026-02-14 2026-02-14 , online online, 690 € zzgl. MwSt. Dr. med. Markus Hahn https://www.forum-institut.de/seminar/26052500-clinical-trials-for-medical-devices-in-the-eu/referenten/26/26_05/26052500-clinical-trials-for-medical-devices-in-the-eu_hahn-markus.jpg 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.

Topics
  • 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.
Aims and objectives
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.
Your benefit

  • 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

Clinical-Trials-for-Medical-Devices-in-the-EU

Clinical Trials for Medical Devices in the EU

MDR / ISO 14155

Benefits
  • Practical study guidance
  • Strong regulatory clarity
  • Reliable compliance alignment
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 26052500

Jetzt buchen

JETZT Buchen

Referent


Alles auf einen Blick

Termin

20/05/2026

20/05/2026

Zeitraum

von 09:00 am - 01:30 pm
(you may dial in 30 min before the session starts)

von 09:00 am - 01:30 pm
(you may dial in 30 min before the session starts)
Veranstaltungsort

online

online

Gebühr
Your contact

Verena Planitz
Conference Manager

+49 6221 500-655
v.planitz@forum-institut.de

Details

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.

Topics

  • 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.

Aims and objectives

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.

Your benefit

  • 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

Detailed programme

von 09:00 am - 01:30 pm
(you may dial in 30 min before the session starts)

Introduction & Welcome


Dr. med. Markus Hahn

Regulatory Framework & Study Types in the EU
  • MDR and MPDG
  • Types of clinical investigations

Dr. med. Markus Hahn

Submission, Approvals & Study Site Requirements
  • Registration in public databases
  • Approval procedures at Ethics Committees and Competent Authority
  • Application under Art. 70 MDR and notification pathways
  • Selection of suitable study centres (MDR Art. 62, MPDG § 35)
  • Investigator qualifications
  • Patient insurance requirements

Break


Dr. med. Markus Hahn

Study Conduct: Data, Monitoring, Safety & Documentation
  • Data management and statistics (ISO 14155; Annex A)
  • Trial Master File (TMF) and Investigator Site File (ISF)
  • Site Initiation Visit (onsite vs. remote)
  • Informed Consent Process
  • Monitoring (risk-based monitoring, SDV, co monitoring)
  • Safety reporting (SAE timelines, CA obligations, serious incidents, PMCI Art. 87-90 MDR)

Break


Dr. med. Markus Hahn

Close-Out, Inspections & Reporting Obligations
  • Close-out visit
  • Site audits and inspections
  • Clinical Study Report (CSR), lay summary, public availability
  • Filing and archiving

End of Seminar


More information

Technical requirements

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We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.

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All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.

On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.

Learn more about our online events here.

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

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