New MD and IVDMD regulation

New MD and IVDMD regulation

Reconciling Ethics and Business

Two 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,
  • traceability,
  • post-marketing vigilance and monitoring system...
This truly amounts to a revolution, one that SEA Avocats will help you anticipate and manage.

Your dedicated team of attorneys