Europe - Nov 2020

  • EU: Common Specifications for the reprocessing of single-use devices

  • EU: EUDAMED actor registration module to launch in December 2020

  • EU: Guidance on adverse incident reporting of insulin infusion pumps and integrated meter systems

  • EU: Notified Bodies may use MDSAP reports to inform their surveillance activities

  • Ireland: Proposed medical device fees for 2021

  • Ireland: Basic check list issued to help Class I manufacturers comply with the MDR

  • Netherlands: Emergency use of non-CE-marked medical devices has now ended

  • Portugal: New Medical Device Information System (SIDM) to be launched

  • Switzerland: Information leaflet updated on exemptions for non-compliant devices

Click here for the full article on Global Regulatory Express.

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