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.

Contact us at info@arqon.com.


16 views

Recent Posts

See All

Europe - May 2020

Denmark: New rules mean non-serious adverse events may also need to be reported EU: Application of Regulation (EU) 2017/745 postponed by one year EU: Continued use of lead as a thermal stabiliser in P

EU: MDR delayed to 26 May 2021

Application of the Medical Devices Regulation (MDR) has been deferred by one year, until 26 May 2021, for fear of shortage or delay in getting essential medical devices needed to combat Covid-19. The

  • LinkedIn - White Circle
  • YouTube - White Circle
  • Twitter - White Circle
  • LinkedIn - White Circle
  • YouTube - White Circle
  • Twitter - White Circle

Services

Contacts

Call us:

   : +65 6909 0396

   : +65 9067 1432

 

Email us: info@arqon.com

Resources

© 2020 ARQon All Rights Reserved. 

  • LinkedIn - White Circle
  • YouTube - White Circle
  • Twitter - White Circle