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▶ 주제: Importer/Distributor MDR Requirements and Impacts for Manufacturers
▶ 일시: 2024년 09월 11일 CST 09시 (한국시간: 09월 11일 23시)
Economic Operator (EO) is a term not identified in the Medical Devices Directive 93/42/EEC (MDD). The Medical Devices Regulation (EU) 2017/745 (MDR) defines in Article 2 what an EO is. There are four types of entities/organizations: manufacturer, authorized representative (AR), importer and distributor. Each of these members of the medical supply chain shall be compliant with the applicable requirements of the MDR. The MDR increased the level of regulatory obligations of all EOs. Importers and distributors now have very clearly defined roles and responsibilities, but not all of them may be aware of these new requirements and how to handle them. Importers/Distributors may decide to set up a quality management system (QMS) in order to suitably and effectively cover these new requirements. From the manufacturer side, these new obligations may also trigger the need for reorganization of the current distribution chain (designate a new importer) and/or to revise current supply and distribution agreements/contracts and/or conduct on-site audits.
This webinar provides an overview of the changes introduced by the MDR for medical device importers and distributors and indirectly for manufacturers. It addresses the responsibilities of each and explains how this can be handled to avoid issues and actions from EU authorities and/or Notified Bodies (NB) potentially causing sales disruptions.
Importer/Distributor MDR Requirements and Impacts for Manufacturers | Emergo by UL
Importer/Distributor MDR Requirements and Impacts for Manufacturers
In this complimentary webinar, our Emergo by UL expert will share insights on importer/distributor MDR requirements and impacts for manufacturers.
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