Medical Device White Paper Series Sterilization ...

covered 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

  Gspr

IVDR Conformity Assessment Routes - BSI Group

Performance 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

  Assessment, Route, Conformity, Ivdr, Gspr, Ivdr conformity assessment routes

General Safety & Performance Requirements in the new MDR

14 Infection and microbial contamination – SPR 11 • 11.1 (a) New: “reduce as far as possible and appropriate the risks from unintended cuts and pricks, such as needle stick injuries” • 11.1 (c) New: “reduce as far as possible microbial leakage from …

MDR 2017/745 - New EU Regulation for Medical Devices: A ...

Abstract On the 26th of May 2021 the new regulation for medical devices, MDR 2017/745, will come into force. The underlying incentives to go from the medical device di-