MDCG Position Paper on UDI Assignment between Manufacturers and Distributors
With the intention of providing clarification concerning which entity should be responsible for seeking and registering UDI-DIs in the EU, the MDCG has published a related Position Paper. The Paper is specifically intended to clarify the role of distributors in acquisition of UDI-DI codes from EU UDI issuing entities.
The Position Paper:
New MDCG Position Paper on Management of SSCP and SSP in EUDAMED
The MDCG has published a brief Position Paper concerning responsibility for the management of summary of safety and clinical performance (SSCP) and the summary of safety and performance (SSP) following their upload to EUDAMED. Until now, Article 32.1 of the MDR imposed responsibility for uploading SSCPs and SSPs on the notified body.
Article 10a Decison Tree
Article 10a of the MDR governs obligations imposed on manufacturers and the competent authorities of EU Member States in case of interruption or discontinuation of supply of certain devices. The European Commission has developed an Article 10a Decision tree. The purpose of the Decision tree is to provide support to manufacturers
Team-NB publishes position paper on Combinatorial Use of Reagent Devices
Team NB published a new position paper on Combinatorial Use of Reagent Devices. The position paper is intended to clarify notified body expectations concerning demonstration of safety and performance of reagents used with other equipment.
The position paper covers reagents that are categorized as “closed systems” (defined …