MDR and ISO14155 (2020)

Description
Regulatory

The Medical Device Regulation (EU 2017/745) has been published and will replace the Medical Device Directive (93/42/EEC) as the legislation detailing the requirements that manufacturers have to meet to place medical devices on the market in the European Union. The MDR describes the need for clinical evaluation and post-market clinical follow-up. Next to the new legislation, an updated ISO14155 is expected to be published in 2019, providing guidance and requirements on how clinical data should be collected.
This full-day training will focus on the impact of the new MDR and the updated ISO 14155 on clinical investigations and our daily work in clinical research.

At the end, you will receive a certificate and the course hand-outs.

Learning objectives

By the end of this TRIUM Training you should be able to:

  • Summarize the applicable regulatory framework for medical devices in the EU.
  • Identify the key changes to the requirements related to clinical investigations today.
Intended audience

Fundamental Level
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.

Trainer
Stefan Hosten
Stefan Hosten is a Clinical Research Professional and owner of Clinops Consulting with over 23 uears of experience in the field. Since 2001 he exclusively focusses on medical devices in all its aspects: field technique support, surgeon implant training, senior project management, European and US Medical Device legislation training and strategic advise to medical device start-up companies.