Europe - Mar 2019

March 29, 2019

  • EU: More advisory documents issued to support implementation of MDR and IVDR

  • EU: Manual on borderline and classification issues updated

  • EU: New form for medical device incident reporting by manufacturers

  • Serbia: Registration requirements, wholesale dealing and manufacturer obligations covered by new legislation

  • Serbia: New ‘Law on Medical Devices’ fully implemented; electronic submissions now accepted

  • Spain: Clinical investigations involving CE marked devices may now be notified to AEMPS electronically

  • Spain: Launch of national registry of pacemakers and ICDs

  • UK: MHRA issues guidance and drafts contingency legislation for a no deal scenario

  • UK: Guidance updated on leadless cardiac pacemaker therapy

 

 

 

Click here for the full article on Global Regulatory Press.

Contact us at info@arqon.com.

 

Please reload

Recent Posts
Please reload

Categories
  • 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

© 2018 ARQon All Rights Reserved. 

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