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FDAnews Device Daily Bulletin
April 4, 2012 | Vol. 9 No. 67
EC Guideline Sheds Light on Role of Authorized Representative
The European Commission (EC) has published a final guideline aimed at clarifying the relationship between devicemakers and their authorized representatives (AR). It also spells out European Union (EU) member states’ expectations of ARs and their client relationships. The guideline (MEDDEV 2.5/10), which is based on current EC medical device directives, is the first comprehensive document to demystify the role ARs play as go-betweens for local regulatory authorities and devicemakers without offices in the EU.
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