Importer/Distributor MDR Requirements and Impacts for Manufacturers

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.

About the presenter

Rachel Paul-Zieger, senior consultant, quality and regulatory affairs

Rachel Paul-Zieger has over 13 years of experience in the medical device industry as well as international experience in high-risk device regulatory submissions and quality assurance requirements. Rachel’s accomplishments include nine FDA 510(k) clearances; 10+ EU Technical Files/Design Dossiers; writing more than 25 Clinical Evaluation Reports; implementation of five quality systems to ISO 13485/CE Marking/FDA QSRs/CMDCAS; quality system gap assessment and improvements; auditing for compliance to multiple standards; conducting training to various international regulations; more than 30 global regulatory strategy analyses; and compilation and submission of numerous registration dossiers for international marketing authorization.