Changes to MDD commence soon

  • Do you plan to submit a new MDD submission?
  • Is your current CE certificates under the Medical Devices Directive (93/42/EEC) is due for renewal?

You need to take immediate action to meet the following deadlines:

  • New CLASS III Devices – No later than March 2019
  • New CLASS IIb Devices – No later than May 2019
  • New CLASS IIa Devices – No later than March 2019
  • New CLASS I Devices – No later than August 2019

It’s important to note that you need to COMPLETE your audit by these dates, which means you need to schedule your audit asap!

Alexander: