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Tuesday, February 14, 2012 8:12 AM
Devine Guidance: IVDD Article 18 – Decisions in Respect of Refusal or Restriction
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Article 18 (Decisions in Respect of Refusal or Restriction) of the IVDD (98/79/EC) delineates the notification requirements for Member States pertaining to the refusal, restriction, or decision to withdraw of bad medical devices from the European Union (EU) device market. In short, Member States can execute their legal right, under Article 18, stating their case; a device manufacturer’s medical devices are hurting or have the ability to hurt their citizens. Can you say the Member S more...
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