EU AUTHORISED REPRESENTATIVE
Sensus Group are pleased to offer a comprehensive Authorised Representative service for both Medical Devices (in accordance with 2017/745/EEC) and In Vitro Diagnostic Devices (in accordance with 2017/746/EEC).
The choice of an authorised representative in Europe is a key strategic decision for any organisation seeking access to the European Union and Sensus Consulting is the logical for this key role. We offer these services to you backed up by experienced responsible person support and a keen understanding of the range of services you may need to access throughout a products lifecycle. This includes but is not limited to:
- Post Market Surveillance Support
- EU Vigilance Support
- Field Safety Action Support
- Legal Support
- Market Development Support
- Quality Systems Development
- Regulatory Affairs
- Clinical Research Support
Let us be part of the future of your access to the European Union
For immediate dialogue on this please contact Richard@sensus-group.com or on any of the contact details below.