Unconference Session 3: Medical Certification

Do you really need certification for a microscope? How you go about this is quite country dependent… Pathplogists might not care if it’s certified or not; ultimately it’s up to the discretion of the pathologist, and many are happy they can tell if the microscope is not producing good images.

General purpose microscopes are either self-certified (EU IVDD/IVDR) or exempt (FDA), but whole slide imagers for oncology are often quite a high risk class. If we are careful about intended use, the microscope as-is would be a general purpose laboratory instrument. Sold for malaria/cancer diagnosis, it could be in a much higher risk class, and that’s probably a matter of whether any software attempts to assist with diagnosis. We need a watertight separation between imaging hardware/software and analysis software; most likely, the OpenFlexure project will not include the latter. There’s some thinking along these lines in the medical page.

Acceptance by medics is key: we can do this by publishing papers, and presenting at medical conferences - evidence to show medical people it works. Daniel is making some great progress on this!
There are some WHO procedures that mandate digital imaging, we can help there and that might be a good “in”.
ISO13485 can help people trust it
Could we start with medical education/research first?
Does the FDA need to certify microscopes? Screens for the display of pathology images are tightly regulated, but the microscope itself may not need to comply.
Certification is handled differently in different countries depending on the governments - variation from Tanzania to Cameroon.