Today we are at the eve of the biggest change in the Medical Device Legislation in the last 20 years.
Significant technological and scientific progress in the Medical Device field and the need to ensure a consistent high level of patient safety were the most important triggers for the creation of the new EU Medical Device Regulation (MDR) and the updates to the MEDDEV guidelines and the ISO14155 Standard. The EU MDR will effectively replace the Medical Device Directive (93/42/EEC) and Active Implantable Medical Device Directive (90/385/EEC).
Next to a brief overview of the present state of the industry, this TRIUM Session will mainly focus on what to expect for the future with regards to these changes in the legislation, like the product scope expansions, the more stringent clinical evidence and the more rigorous post-market oversight requirements amongst others.
At the end, you will receive a certificate and handy hand-outs for later use.
By the end of this TRIUM Training you should be able to:
- Describe the history of device standards, directives and guidelines to date
- Explain the current and/or expected changes in the relevant EU Medical Device Regulation, MEDDEV guidelines and ISO14155 standards
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.