Europe - Aug/Sep 2018

  • EU: Manual on borderline and classification issues updated

  • France: Decree on summary of characteristics for Class III/implantable devices cancelled

  • Germany: BVMed believes medical technology should be removed from proposed European HTA legislation

  • Germany: German industry associations call for urgent action to deal with Medical Devices Regulation implementation issues

  • Ireland: Proposed medical devices fees for 2018

  • Spain: CCPS replaces PMPS for online submission and management of device applications

  • Switzerland: New system for issuing Export Certificates and Manufacturing Certificates

  • Switzerland: Clinical trial approvals will be handled electronically from September

  • UK: Guidance on medical device software apps is updated

Click here for the full article on Global Regulatory Press.

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