Manufacturers of Class I Reusable Surgical Instruments must now obtain a CE certificate under Annex IX Chapters I & III or Annex XI – Part A (limited to the re-usability aspects, as appropriate) by no later than May 26th, 2020 for these devices.
Failure to do so will exclude them from placing these devices on the EU market from May 26th, 2020 onwards or until you achieve CE certification.
To be clear your current medical device registration (MDD) will become invalid on May 25th, 2020. You must act now if you wish to continue to CE mark and supply these devices.
Remember, while Notified Body CE certification is limited to the aspects concerning the reusability of your devices, all your technical documentation must also be upgraded to comply with the MDR and Advena can assist with the technical file upgrades.
Time is now running out and there are only two Notified Bodies currently designated to MDR (BSI UK & TUV SUD). The EU Commission have promised that more will be available by the end of the year, therefore, it makes sense to begin the process of upgrading your technical documentation/files now. So, you need to instruct your regulatory team to begin preparations, if you don’t have the resources internally please do not hesitate to contact us, as mentioned above, we can help!