Change is on its way – medical devices law will not be the same again as of next year.
The authorities are not your friend anymore.
Notified bodies are engaging in massive ‘panic soccer’ (Dutch expression) dropping companies like they’re hot.
If you have not implemented the new clinical evaluation MEDDEV fully by now this should have your utter undivided attention. Otherwise, count on your CE certificate for the device(s) affected being suspended without warning after the next notified body audit. And make sure to watch that your notified body does not enthusiastically suspend the entire certificate for all your devices by mistake and then runs away to hide under a rock while you can go deal with the fall-out. I’ve seen this happen already. Panic soccer – be prepared and make sure you keep your eyes on the ball.
You should already be well into your transition work for the MDR and IVDR, or at least have a plan about what to do when. The EU will not grandfather, so do not count on this to happen. For every device on the market you need to take a decision to
- remediate (bring it into compliance with the MDR/IVDR),
- replace (replace it with a device that is or will be compliant the MDR/IVDR), or
- retire the device (investment too high to phase it into the new requirements).
EU medical devices legislation will go supernova to more than six times its current size halfway 2017. Is your company prepared for that?
Have you thought about the impact of the General Data Protection Regulation? It’s not devices law per se but its privacy by design obligations impact your new software design requirements under the MDR, just to mention one thing. You need to prepare for its data portability requirements. If your medical device or related service has any IoT functionality, it will be affected by the hateful eight that this new EU law brings. It will impact severely on your clinical data processes (as it deals with protection of personal data concerning health). It is already in effect, and its transitional period will end on 25 May 2018. Can you redesign your data processing hardware and software before that time, and do you need to? Just one of the questions you should be asking yourself now.
Busy times ahead
Yet, I wish you quiet, joyful and festive holidays for the moment (no implied warranties). Recharge, and keep your eyes on the ball in 2017.