Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Do the Periodic Safety Update Report (PSUR) and Summary of Safety and Performance requirements (SSP) have to be generated by individual device or can they be generated by device family under MDR? 1.59K viewsMedical Device 0 Votes 1 Ans How does the MDR impact the regulation of device-drug combination products? 1.59K viewsMedical Device 0 Votes 1 Ans Can you summarize any impact of the MDR on devices containing tissues of animal origin and how they are regulated? 1.56K viewsMedical Device 0 Votes 1 Ans When will I need to have implemented the use of UDIs by? Will there be a transition period for existing products? 1.49K viewsMedical Device 0 Votes 1 Ans At what level is the use of UDI no longer applicable, with regards to individually packaged items and items packaged in a single container? 1.55K viewsMedical Device 0 Votes 1 Ans Is the use of UDIs applicable to transport packaging and outer packaging? 1.53K viewsMedical Device 0 Votes 1 Ans Has the EU clarified the use of UDI as it relates to software-only devices? 1.42K viewsMedical Device 0 Votes 1 Ans Are the new UDI requirements aligned with the current US FDA UDI requirements? 1.33K viewsMedical Device 0 Votes 1 Ans Can I use a UDI issued by GS1 to meet the requirements of the MDR? 1.67K viewsMedical Device 0 Votes 1 Ans Will compliance with the Global Trade Item Number (GTIN) meet the UDI requirement? 1.73K viewsMedical Device 0 Votes 1 Ans What is the transition period for the MDR (Medical Device Regulation)? 1.65K viewsMedical Device 0 Votes 1 Ans Will the new requirements be enforced retrospectively under MDR? 1.50K viewsMedical Device 0 Votes 1 Ans What happens if my certificate isn’t issued before the end of the transition period under MDR? 1.77K viewsMedical Device 0 Votes 1 Ans Can I apply for an MDD certificate once my Notified Body is designated under the MDR? 1.28K viewsMedical Device 0 Votes 1 Ans When will BSI begin conformity assessment against the new Regulation under MDR? 1.80K viewsMedical Device 0 Votes 1 Ans Can BSI provide consulting support if they are currently our organization’s Notified Body under MDR? 1.55K viewsMedical Device 0 Votes 1 Ans Will BSI Certification Panel reviews occur before or after Commission reviews under MDR? 1.72K viewsMedical Device 0 Votes 1 Ans Is there a deadline for my QMS to be compliant with the MDR? 1.75K viewsMedical Device 0 Votes 1 Ans How will the new MDR impact contract manufacturers? 1.46K viewsMedical Device 0 Votes 1 Ans What devices are covered by the MDR? 1.74K viewsMedical Device « Previous 1 2 … 187 188 189 190 191 … 283 284 Next » Question and answer is powered by anspress.net
