Pre-Market Notification

Notification for IVDs:

Manufacturers  placing a device on the European market have to notify the Competent  Authority of the EU Member State where they have their Registered  address.

For non-EU manufacturers: Appoint a European  Authorized Representative established within the European Union, which  will notify the IVD towards the EU CA where they have their Registered Address.

Learn More

• Scope
• The Directive: IVDD 98/79/EEC
• Path to EU Market Entry
• Pre-Market Notification
• Notified Body
• Authorized Representative
• Risks of Non-Compliance

Any questions related to IVDD? Contact us now!