7 questions to check the status of your medical certification

This article is written for digital health startups that currently have a MDD class I product in the market or, as some people may say, a class 1 CE certification. Consider this article to be a high-level checklist to double-check your documentation. Why is this necessary you may ask? Aren’t the requirements as laid out by the Medical Device Directive (MDD) clear? Well, if you feel confident and have gone through the list of Essential Requirements yourself, you may not need to read further.

The MDD is pretty vague. And some interpretations of how to implement those requirements have been pretty low-effort in the past. While this is of course very startup-friendly, supervisory authorities may expect a different level of detail and structure.

Without further ado, here is the list:

1. Is your documentation a large monolith? Or did you split your documentation into manageable chunks?
2. Do you have a clear (mental) separation between quality management system (QMS) and technical documentation (TD)? What SOPs do you have in place?
3. How diligent is your clinical evaluation? Have you heard of (or maybe even followed) MEDDEV 2.7/1 rev. 4? Or is it a list of some publications with some commenting text?
4. How does your risk management look like? Have you applied the stringent logic of ISO 14971 where you focus on medical harms? Or do you have a rather wild collection of various topics?
5. Do you have documented results of a market surveillance?
6. Would you know what to do when an incident happens that you may have to report?
7. Is all of that a one-man-show or a group effort?

This is not meant to be a full list of what you need to have in place. It’s just a short checklist to check the maturity of your documentation.

If you happen to be a medical device professional with decades of experience, then this list probably makes you cringe. My experience of having worked with various startups in the field is that they usually have a very strong quality culture. Though just doing things right is not sufficient in the medical device world. Relevant information have to be documented.

Photo by Glenn Carstens-Peters on Unsplash