Three reasons to leave
#1 The FDA promotes the supply, the EU manages the lack
Two examples show the different approaches the FDA and the EU take to ensure the supply of medical devices:
- The FDA recently contacted a German medical device manufacturer and asked what it could do to help him bring his innovation to the US market.
- The EU is planning another regulation forcing medical device manufacturers to report if they withdraw critical devices from the market.
Behind the scenes, the authorities in the EU fear that they will be inundated with these reports. After all, what are they supposed to do with them? It is still completely unclear what the consequences will be.
Apart from more bureaucracy for manufacturers.
The German media constantly report on the effects of this "MDR bureaucracy," most recently Focus (only available in German).
#2 The FDA offers reliability, the EU stirs up uncertainty
USA: FDA
We accompany manufacturers at pre-submission meetings on an ongoing basis. At these meetings, the FDA always provides clear answers to questions, and manufacturers receive certainty in their planning.
The FDA has set itself deadlines. It publishes (mostly) comprehensible guidance documents, which are already available for comment in draft form (such as the one on cybersecurity).
I will leave the comparison with the MDCG guidelines to you.
Europe: Notified bodies
In Europe, our customers struggle with the fact that hardly anyone wants to take responsibility and answer questions. Not even simple questions like:
- When can we expect a date for a TD review?
- When will we finally receive the certificate after our successful audit?
- What should we do to rectify non-conformity XY? ("We are not allowed to consult.")
- Do we have to comply with this requirement in the MDCG document (even though there is no justification for it in the MDR)?
The effect of the lack of answers: (planning) uncertainty and stress for manufacturers.
We are also receiving new complaints from manufacturers. Some suspect that the long approval times are not only due to an overload of notified bodies but also to an "underload" of capacity utilization: they have the impression that the notified bodies are artificially increasing their efforts to utilize capacity.
We have not yet collected any data on this.
Europe: Authorities
Even to inquiries to the authorities, manufacturers regularly receive
- no answer,
- the answer that they are not responsible (and that others are to blame),
- answers that we cannot bring into line with the law,
- answers that are too vague to create legal certainty.
The result: uncertainty, stress - and the desire to start in the USA.
The AI Act passed last week will only add to the list of questions.
#3 Approval is faster in the USA
Approval is not only easier to plan in the USA, but it is also faster. If the FDA really wants a device, it finds ways and means to speed up its approval. In Europe, we are slower and, unfortunately, do not have a suitable conformity assessment procedure for medical devices that are urgently required.
