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.
This 3-hour course will focus on the impact of the new MDR 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.