Notified Body: Congratulations! You have successfully submitted an application with a notified body for CE marking under the MDR!
Time to break out the…
SCREEEEEEEECHH… (*record scratch*)
Notified Body: During review of your application, we have identified some questions with respect to your device classification.
D’oh!
We all make mistakes from time to time. Remember that old adage: Fail early, fail often? Perhaps I’m mixing up my old adages, but a lot of growth can come from mistakes. A common recent finding during MDR CE marking applications relates to a disagreement in device classification, whether for a class I “self-certified” device under MDD being upclassified under MDR, (mis-)application of a somewhat interpretable definition, or simple disagreement between two interested parties.
That said, the key is all in the recovery! For those finding themselves in need of revisiting device classification and justification, here are some thoughts on a graceful “tuck and roll."
First, be open to the idea that neither you nor your notified body is right… or wrong. In most cases, there is truth to both perspectives that will come out with an honest, diligent review of relevant definitions and potential classification rules. Perhaps the original person or team classifying the device made too many unstated assumptions. Perhaps the notified body is exaggerating risk concerns due to a lack of information and rationale. The point is: anger and frustration only get you so far.
Second, take advantage of additional guidance documents and examples. Definitions and rules are not always written by those using them and a good example can help convey intent. MEDDEV 2.4/1 may help answer “What were they thinking?” while MDCG 2021-24, MDCG 2022-5, MDCG 2019-11, and the Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 may help answer “What are we thinking?” Ask others for additional examples or lines of reasoning. There may be multiple paths to a viable classification; map them out.
Third, it’s not required to present all of your thinking, rambling explanations, creative ponderings, exclamations, and extreme rationalizations back to the notified body. In fact, please don’t. But do provide a concise justification explaining application of the most relevant definitions and potential rules considered. If there is still disagreement, MDR Article 51 outlines the process to formally dispute the device classification with competent authorities.
Though seen in some circles as a four-letter word, a CAPA may provide an actionable roadmap for needed activities and will often be expected by your notified body. Depending on specific conditions, a change in device classification may require changes to labeling, technical documentation, and level of review. In all cases, an updated declaration of conformity will be needed. Another four-letter word (FSCA) may come up for consideration, though in some cases a more palatable three-letter acronym (FSN) will suffice.
Lastly, if you have an EU Authorized Representative, they may have additional requirements or advice, depending, again, on the specific change to be made. MDR Article 59 might also be able to be leveraged allowing devices to be placed on the market prior to issuance of a needed MDR certificate. Consider the effects on any local registration requirements. And, in all cases, ensure the device meets applicable requirements prior to placing any further product on the market.
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Learn more about the author: Kara Budor, M.S., Director, International Regulatory Affairs.
Learn about MCRA's European MedTech Services here.