EU Medical Device and IVD Market Regulatory Strategy Report
Market authorization in the European Union requires obtaining CE Marking for your medical device. The CE Mark indicates that your device meets requirements of the European Medical Devices Directive (MDD), In Vitro Diagnostic Devices Directive (IVDD) or Active Implantable Medical Devices Directive (AIMDD). Most compliance routes in the EU also require implementation of an ISO 13485 Quality System.
However, requirements in Europe will soon change. Europe’s new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) have been released, and manufacturers must comply with these regulations before the deadline.
Let Emergo assist you in evaluating the EU medical device regulatory framework as it applies to your device(s)
Emergo has an extensive network of in-house experts as well as industry and regulatory sources throughout the European Union, enabling us to develop in-depth and accurate analysis of the EU medical device market.
Our Global Regulatory Overview report service for the EU covers topics including:
- Regulatory background on Notified Bodies and Competent Authorities
- Product assessment
- EU Authorized Representation
- Medical device registration requirements
- Costs and timeframes
- Labeling and language requirements
- EU regulatory roadmap
Please contact us for more information about our Regulatory Overview Report for Europe.