Comparative regulation US-EU

By Talyta Carteano: Medical Device Director at Asphalion

We held a new Breakfast & Learn session dedicated to comparative regulation between the United States and the European Union .

We had the participation of Talyta Carteano , Medical Device Director at ASPHALION MedTech , who shared her experience on the regulatory requirements for the commercialization of medical devices and the main differences between the European framework ( MDR/IVDR ) and the American ( FDA ).

Some key points from the session:

• The CE marking has certified that the product meets the safety, health and environmental requirements in the EEA.

• The Notified Bodies (NB) have evaluated the technical documentation, post-marketing surveillance and clinical evidence.

• The classification of devices depends on their invasiveness, activity and duration of use.

• In the US, the FDA has regulated devices through the 510(k) or PMA processes , with very strict clinical and safety requirements.

Conclusion : Both the European MDR/IVDR framework and the American FDA have demanded rigor, post-marketing monitoring and regulatory compliance. Each market has required a specific and detailed approach.

You can watch the video of the session here.