Archiving period for data from clinical investigations

• Jill
  04/03/2015 17:33

  Hi, I'm struggling to find an answer to this and was hoping someone could point me in the right direction? How long does the data from a clinical trial of a CE marked device need to be retained and are these requirements different for clinical investigations that will feed into an application for a CE mark? Many thanks, Jill
• Henny Koch
  10/03/2015 09:50

  Dear Jill, Please see Annex XIV (final paragraph) of the new draft directive 93/42/EC final concept 2012. Also check with local regulations and ask your Notified Body. They should know and be able to help you. Regards, Henny

Share your experience on trustpilot.com