Obelis European Authorized Representative Center
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Obelis News:
New MEDDEV on Authorized Representatives
Published 19 Feb 2012
The EU Commission released a new guidance document for the European Authorized Represenatives (EAR) last month relating to questions of application of the EC-Directives on Medical Devices.
This new document sets important guidelines for the EARs in respect to two features:
- It summaries the roles and responsibilities of the Authorized Representative as mentioned in the medical devices Directives (MDD/93/42/EEC; AIMDD 90/385/EEC; IVDD 98/79/EC)
- It also describes the expectations of the European Union Member States regarding the role of the EAR concerning market surveillance
For the main highlights of the new guidance document for EARs on the application of MDDs, read our PUBLICATION or contact us for further support.
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