Search results with tag "Gspr"
The GSPRs (General Safety and Performance Requirements ...
d2evkimvhatqav.cloudfront.netapply later on. There is a need to constantly review the evidence held to support each GSPR, taking into account the current state of knowledge in Europe regarding the device and its use. NSF has developed a tool to easily compare the GSPRs of the IVDR and the essential requirements of the IVD Directive.
IVDR Conformity Assessment Routes - BSI Group
www.bsigroup.comPerformance Requirements (GSPR) within the IVDR. 7 Class A devices Note: No Notified Body involvement Class A (excluding sterile devices) Annex II and III Technical Documentation CE Marking (Annex V) CE Declaration of conformity (Annex IV) Self declaration. 8 Class A sterile devices Class A sterile Annex II and III
Medical Device White Paper Series Sterilization ...
www.medical-device-regulation.eucovered in GSPR 13 - Devices incorporating materials of biological origin and Directive 2003/32/EC3. 11.3. Devices labelled as having a specific microbial state shall be designed, manufactured and packaged to ensure that they remain in that state when placed on the market and remain so under the transport and storage conditions