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