Most of you have probably been reading articles and going to `presentations on the new Medical Device directive. This is something that is approaching every day a bit more (24 h, to be exact). What the important issue here is not how to comply with it, which is more a technical issue, than which are the consequences that this will bring to the companies, especially the small ones. I did put a few together:
- More investment. You will need to dump more money on the table if you want your product trough. More test, more documentation, more money. That is the main issue for me. Big companies have been pushing to get the process more complicated for small companies
- Less power to Notified Bodies. End of one to one negotiation. Big brother EMA will check that everything is Ok and all NB is doing exactly the same under the same criteria. Not bad, but it’s coming. And will create disorientation a delays
- More Clinical research. Prepare your financials to support a wave of clinical trials (getting very time more and more expensive) which will be needed. Again, not bad in itself, but that will make development more costly.
- More post-market surveillance. The follow up will be strengthened and the companies which externalize this processes will need to find one with enough resources free for them and prices will go up no doubt.
- Chaos (at least at the beginning) How will the ex-ante control for high-risk devices work? I bet no one has a clue by now. Who will carry this? Under which criteria? Who will validate the process? Wil I be able to re-submit after how long? How many times?
In summary, hold on. Next year will be no fun, and from 2020 it will be a roller coaster. I would be rushing for approval ASAP if I were you…..
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