There seems to be a bit of an element of putting fear into Medical Device manufacturers, or am I being paranoid?
Steve, thank you very much for the update.
It seems to me that the European Commission is cracking down on the conformity assessment practices because, as we all know, there is significant variation in the conformity assessment practices performed by Notified Bodies and Conformity Assessment Bodies.
Regulatory agencies are under continual societal and governmental scrutiny to manage the risks of their respective supply chains, so, they will continually increase the strictness of the conformity assessment protocols in order to minimize the chances of nonconforming products and systems being allowed into the marketplace.
Unfortunately, there are interested parties in the conformity assessment sector who don't take their responsibilities serious enough and allow substandard products and systems to attain and maintain the certificates that they need to trade. Even more unfortunate is the fact that a percentage of the manufacturers deliberately seek and retain incompetent auditors, conformity assessment and notified bodies because they represent an easier and cheaper path to the approvals they need.
I would think that the responsible medical device manufacturers should not worry too much. They might see more strict audits and an oversight process a little more expensive. Conversely, the people who like to shortcut the processes should worry.