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? 1.55K viewsMedical Device 0 Votes 1 Ans How does the MDR impact the regulation of device-drug combination products? 1.54K 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? 1.51K 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be a transition period for existing products? 1.43K viewsMedical Device 0 Votes 1 Ans At what level is the use of UDI no longer applicable, with regards to individually packaged items and items packaged in a single container? 1.50K viewsMedical Device 0 Votes 1 Ans Is the use of UDIs applicable to transport packaging and outer packaging? 1.49K viewsMedical Device 0 Votes 1 Ans Has the EU clarified the use of UDI as it relates to software-only devices? 1.37K viewsMedical Device 0 Votes 1 Ans Are the new UDI requirements aligned with the current US FDA UDI requirements? 1.30K viewsMedical Device 0 Votes 1 Ans Can I use a UDI issued by GS1 to meet the requirements of the MDR? 1.62K viewsMedical Device 0 Votes 1 Ans Will compliance with the Global Trade Item Number (GTIN) meet the UDI requirement? 1.67K viewsMedical Device 0 Votes 1 Ans What is the transition period for the MDR (Medical Device Regulation)? 1.58K viewsMedical Device 0 Votes 1 Ans Will the new requirements be enforced retrospectively under MDR? 1.44K viewsMedical Device 0 Votes 1 Ans What happens if my certificate isn’t issued before the end of the transition period under MDR? 1.72K viewsMedical Device 0 Votes 1 Ans Can I apply for an MDD certificate once my Notified Body is designated under the MDR? 1.25K viewsMedical Device 0 Votes 1 Ans When will BSI begin conformity assessment against the new Regulation under MDR? 1.73K viewsMedical Device 0 Votes 1 Ans Can BSI provide consulting support if they are currently our organization’s Notified Body under MDR? 1.52K viewsMedical Device 0 Votes 1 Ans Will BSI Certification Panel reviews occur before or after Commission reviews under MDR? 1.66K viewsMedical Device 0 Votes 1 Ans Is there a deadline for my QMS to be compliant with the MDR? 1.71K viewsMedical Device 0 Votes 1 Ans How will the new MDR impact contract manufacturers? 1.42K viewsMedical Device 0 Votes 1 Ans What devices are covered by the MDR? 1.68K viewsMedical Device « Previous 1 2 … 187 188 189 190 191 … 283 284 Next » Question and answer is powered by anspress.net
