CE-marking worthless?

Why is anyone with a sane mind buying a digital health solution CE-marked according to MDD?

A provocative statement that is more important than what most understand. The Medical Device Directive (MDD) was initially released 1993, where the current utility of digital health solutions was not envisioned.

What is the implication of buying a digital health solutions based on the old MDD regulation:

  • The requirements, if properly applied provide a good basis for a safe product. Main drawback is the lack of clarity about the need for clinical evidence.
  • The most important drawback is that there has been no evaluation whatsoever by an independent party. It is all based on the statement of the supplier that they claim that they have fulfilled the requirements.

There are many important differences with the new Medical Device Regulation that was implemented 2017, but which unfortunately allows for a transition period until 2025. These are some key-change in the new regulation:

  • Software as a medical device, which previously most often was classified as class I (lowest risk) will now more often be classified as class IIa, IIb and III.
    • This impacts the scrutiny of the 3rd party evaluator.
    • If you are interested to understand the classification, here is a link to the guidance for classification: https://ec.europa.eu/docsroom/documents/37581
    • Here is an article outlining the problem with digital solutions in melanoma, which previously would be classified as class 1 according to MDD:

Freeman, Karoline, Jacqueline Dinnes, Naomi Chuchu, Yemisi Takwoingi, Sue E Bayliss, Rubeta N Matin, Abhilash Jain, Fiona M Walter, Hywel C Williams, and Jonathan J Deeks. ‘Algorithm Based Smartphone Apps to Assess Risk of Skin Cancer in Adults: Systematic Review of Diagnostic Accuracy Studies’. BMJ, 10 February 2020, m127. https://doi.org/10.1136/bmj.m127.

  • Clear requirements for clinical evidence
  • Digital health solutions with class IIa, IIb and III will require a thorough evaluation of an independent notified body.
    • The requirements for the notified bodies have increased significantly and has reduced the number of notified bodies to a fraction of what was before. The

There are many digital health solutions where a faulty function can have a significant risk for patients. Let’s work together to use solutions that are safe and effective.