Medical Device Medical Device 274 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Are the new UDI requirements aligned with the current US FDA UDI requirements? 1.32K viewsMedical Device 0 Votes 1 Ans Can I use a UDI issued by GS1 to meet the requirements of the MDR? 1.65K viewsMedical Device 0 Votes 1 Ans Will compliance with the Global Trade Item Number (GTIN) meet the UDI requirement? 1.70K viewsMedical Device 0 Votes 1 Ans What is the transition period for the MDR (Medical Device Regulation)? 1.63K viewsMedical Device 0 Votes 1 Ans Will the new requirements be enforced retrospectively under MDR? 1.49K viewsMedical Device 0 Votes 1 Ans What happens if my certificate isn’t issued before the end of the transition period under MDR? 1.75K viewsMedical Device 0 Votes 1 Ans Can I apply for an MDD certificate once my Notified Body is designated under the MDR? 1.27K viewsMedical Device 0 Votes 1 Ans When will BSI begin conformity assessment against the new Regulation under MDR? 1.78K viewsMedical Device 0 Votes 1 Ans Can BSI provide consulting support if they are currently our organization’s Notified Body under MDR? 1.54K viewsMedical Device 0 Votes 1 Ans Will BSI Certification Panel reviews occur before or after Commission reviews under MDR? 1.70K viewsMedical Device 0 Votes 1 Ans Is there a deadline for my QMS to be compliant with the MDR? 1.74K viewsMedical Device 0 Votes 1 Ans How will the new MDR impact contract manufacturers? 1.45K viewsMedical Device 0 Votes 1 Ans What devices are covered by the MDR? 1.72K viewsMedical Device 0 Votes 1 Ans Are there any changes to device classification by the MDR? 1.55K viewsMedical Device 0 Votes 1 Ans Is the Technical Documentation assessment for Class IIb implantable devices based on a representative sample of the generic device group under MDR? 1.50K viewsMedical Device 0 Votes 1 Ans Have the requirements for Technical Documentation for Class IIb products that deliver medicines increased under MDR? 1.69K viewsMedical Device 0 Votes 1 Ans Am I able to self-certify devices under the MDR? 1.47K viewsMedical Device 0 Votes 1 Ans How does a medical device manufacturer determine if a particular type of device qualifies for the retail exemption? 1.40K viewsMedical Device 0 Votes 1 Ans Do the regulations illustrate how the retail exemption facts and circumstances test should be applied on a medical device? 1.59K viewsMedical Device 0 Votes 1 Ans Is there a retail exemption safe harbor for medical device manufacturer? 1.65K viewsMedical Device « Previous 1 2 3 4 5 6 7 … 13 14 Next » Question and answer is powered by anspress.net
