Senior Vice President of Medical Health Services (global) TUV SUD Product Services
The MDR introduces many requirements related to Economic Operators. This session will address many issues/questions which remain when it comes to implementation of said requirements. These include:
1. How can a manufacturer handle the various verifications the manufacturer, importer and distributor need to perform and avoid duplication? With practical examples. 2. Is "placing on the market" and "making available" triggered by PHYSICAL ownership AS WELL as legal ownership? 3. Are 3rd Party logistics providers who are Fulfillment Service Providers also distributors? 4. Challenges with the point of "placing on the market" for capital equipment (and devices which must be installed) - who then is the importer? Who is the distributor? 5. Do importers need to perform PHYSICAL verifications to meet Art 13 requirements? e.g. the device is labelled in accordance with this Regulation and accompanied by the required instructions for use 6. Do Legacy (MDD products on market after May 26 2020) need to have verifications performed by Importers and Distributors? 7. Should Economic Operators be managed through the Supplier Management process within the QMS (ISO 13485:2016 clause 7.4)? 8. How will the EC-REP verify conformity assessment? Under what circumstances might they cancel the mandate? 9. What constitutes the “certification” for Distributors under Article 16? How will Notified Bodies assess this and what will the process be for this assessment and the issuance of the “certification”?
Presentations: 1. Keith Morel, Ph.D. – VP Regulatory Compliance, Qserve - Introduction 2. Susan Hibbeln, MS, RAC – Principal Scientific Advisor, Network Partners - Manufacturer's View 3. Ludger J. Moeller – President, Medical Device Safety Service - EC-REP's View 4. Erik R. Vollebregt – Partner, Axon Lawyers - Lawyer's View 5. All Faculty - Discussion/Q&A
Answer many ambiguous questions in this area at present, such as whether physical verifications are required for IFU/labeling per Art 13, and if distributors should be subject to supplier management.
Analyze supply chains to determine what roles every actor plays, and to understand the pros and cons of changes one can make to define the EOs one wants.
Describe the EC-REPs new role and how they will implement it.