New MD and IVDMD regulation
Reconciling Ethics and BusinessTwo new European Regulations: for medical devices (MD) and for In-vitro diagnostic medical devices (IVDMD) came into effect in May 2017 and will be applicable in 3 to 5 years.
How will they impact your products and the organization of your firm?
- modification of the definition and classification of your products,
- clinical assessment and technical documentation,
- strengthening of obligations binding manufacturers, agents, distributors and importers,
- qualified person in charge of regulatory compliance,
- post-marketing vigilance and monitoring system...