This is the most important change since CE marking.
The key changes surround the EU moving away from a directive required by national law, to a regulation that strives to deliver harmonisation in Europe for medical devices. The current regulation allows for a device to be brought to market on the principle of equivalence,
the new regulations withdraw this principle of equivalence and demand further clinical trials. The new legal framework allows for an increase in clinical investigation, post-market surveillance and clinical evaluations.
This movement of responsibility from the manufacturers to the competent bodies is driving a distinct feeling of unrest in the marketplace. There is a 3 year “transition” period from the date of application following entry into force – however the notified bodies and competent authorities are urging medical device companies to start getting processes in place.
In reality, nothing much will change – but anything can.
What is your strategy for this ground breaking change? Contact me to discuss options and hear how the rest of the industry is preparing today!
Dani Hamblin, Head of Contract Division at Projectus Consulting.