Europe - Aug/Sep 2018

Sep 4, 20181 min read

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

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