As Notified Bodies (NBs) in the European Union (EU) begin to roll out Article 16(4) of the European Medical Devices Regulation 2017/745 (MDR) and the European In-vitro Diagnostic Medical Device Regulation 2017/746 (IVDR) certification schemes, we at Emergo by UL share our insights on the requirements set out in Article 16 and their applicability to importers, distributors and other natural or legal persons who make certain modifications to medical devices and in vitro diagnostics (IVDs) placed on the European market. Article 16 of the EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requires that importers, distributors, and other natural or legal persons (third parties) who make changes to the outer packaging of a device already placed on the market — including a change to pack size, or, for example, translating information supplied by the manufacturer — implement a Quality Management System (QMS). The Article 16(4) certification scheme aims to increase transparency, encourage free trade and expand the control of the Competent Authorities (CAs).
Article 16(4) MDR & IVDR Certification: What Medical Device Manufacturers Need to Know
Medical device importers, distributors and others who modify medical devices for sale in the European Union should understand new requirements set by Article 16(4) of the European Union MDR and IVDR certification schemes.
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