Onsite Training

Auditing Clinical Aspects of EU-MDR

What Manufacturers and other Economic Operators should know


With the Medical Device Regulation (MDR) published in 2017 many new requirements were introduced that relate to the systematic collection, evaluation, reporting of clinical data and the continuous demonstration of clinical evidence for safety, performance, and an acceptable benefit/risk ratio of a device. Thus, the MDR enhances the expectation on a compliant systematic approach to collect and evaluate clinical data throughout the device lifecycle in pre- and post-market phases. Included are expectations for a systematic and active post market surveillance (PMS) and post market clinical follow up (PMCF) System. Several MDCG documents provide additional information on the interpretation and implementation of the obligations to perform clinical evaluations for innovative, equivalent, and legacy devices to ensure clinical evidence for clinical claims on safety and performance. Specifics how to plan, conduct, and document clinical investigations, PMCF studies and manage the reporting to Notified Bodies (NB) and Competent Authorities (CA) are aspects that contribute to a high level of transparency and scrutiny. The role of the European Database for Medical Devices (EUDAMED) or alternative solutions need to be understood to ensure the reporting obligations and communication with EU Commission, EU Pannels, CA, NB and Public.  All provision defined in MDR and related regulatory framework need to be mirrored in the manufacturers Quality Management System. Auditing all relevant clinical aspects of the MDR are an expected integral part of the internal audit program of the Manufacturer.

Hotel recommendation:
Arthotel ANA Goggl, Hubert-von-Herkomer-Straße 19, 86899 Landsberg am Lech, Phone: +49 8191 3240

Net price

€ 1260.00

Overview of covered topics

Purpose of the training

The participants shall be enabled to:

Who should attend

Basic knowledge required

Presenting experts

Our trainers have long-time experience working with one of the biggest notified bodies and in clinical research and regulatory consulting.

Dr. Susanne Gerbl-Rieger

Senior Consultant

Prof. Dr. Markus Balkenhol

Team Leader - Senior Clinical Consultant

Dr. Anna Spehl

Senior Consultant

More upcoming trainings and webinars

Support & Training

You have not found the right training for you and you would be interested in an offer for a specific and customized training on another topic in the field of regulatory affairs? Or you are interested in support and hands on implementation services?

Scroll to Top
GDPR Cookie Consent with Real Cookie Banner