According to the European law, manufacturers located outside the European Union who wish to market their products in Europe need to appoint an Authorized Representative.
Medical Devices
As your Authorized Representative, Euramedics will assure compliance to the applicable directives (MDD 93/42 EEC - AIMD 90/385 EEC) and act as your liaison to the Competent Authorities and Notified Bodies.
Standard services...
- Authorization to place contact details on all devices, inserts and packaging
- Personal assistance in designing multilingual labels in compliance with Directive 93/42 EEC requirements
- Storage of technical files
- Registration of risk Class 1 devices and all other representation towards Competent Authorities
- Notification of (serious) device incidents and product recalls
Besides these standard Authorized Representative services, Euramedics offers:
- Dedicated relationship serving your company´s best interests
- Streamlined incidence reporting and product vigilance system
- Efficient compliant handling and follow-up
- Regular updates on applicable legislation
We guide you through the different national regulations and get you over the language barriers!