Full length webinar - watch on YouTube|
European Economic Operator Requirements
When the EU MDR and IVDR were published in 2017 these regulations elevated the role of two critical economic operators; distributor and importer. Subsequent to the release of the EU regulations Brexit (UK) and Swixit (Switzerland) happened, introducing new, country-specific requirements for medical
Time & Location
Full length webinar - watch on YouTube
About the Event
With the release of the EU MDR and EU IVDR the term “economic operators” was developed, and defined to encompass manufacturers, authorized representatives and two newly identified groups: distributors and importers. While manufacturers not based in the European Union have understood the necessity to appoint an authorized representative, many manufacturers may not know that it is the manufacturer’s importer that is responsible for officially placing a medical device onto the EU market and for ensuring that they are in conformity with the appropriate regulation.
The timing of the MDR and IVDR has also coincided with Brexit (UK) and Swixit (Switzerland), and that has also created its own set of compliance hurdles, including new requirements for Economic Operators, for not only importers and distributors, but also the requirement for a local “UK Responsible Person” based in the UK and “Authorized Representative” in Switzerland.
This presentation will address the importer and representation requirements introduced by the regulatory changes, along with timelines for compliance.
A live Q&A with the speakers will follow the presentation.