flow-meter™ | Scenario of the medical device certification system - part 3

In addition to the enhanced risk management approach, the New Regulation introduces the concept of device life cycle assessment, from the design phase to the technical, functional and clinical validation phase, production, placing on the market, putting into service and, finally, follow-up actions for feedback data and post market surveillance actions.
Devices therefore no longer only have to comply with essential safety requirements but must also meet general safety and performance requirements.
With the New Regulation, every device must be designed, manufactured, placed on the market and managed as part of a complete system, under the full governance of the manufacturer. This is in view of the awareness of the overall safety of the device, for all phases of its life cycle.
The resulting economic and organizational burdens are easily perceived: only structured realities with a solid and confirmed market, based on historical evidence of safety and control capacity can withstand the impact that these rules have. Unfortunately, it is not necessarily the case that these rules lead to safer products: the need for survival and supply at a sustainable cost may lead to the provision of products with higher performance characteristics, and at the same time to the elimination of products which, in terms of number and cost, is no longer convenient to produce. To what extent this approach then results in a real benefit to overall health from the perspective of extended markets is to be demonstrated. The safety statistics produced by the Competent Authorities over the last 20 years of validity of the CE marking according to Directive 93/42/EEC show that the cases of true non-compliance with extensive and critical consequences are very few, and mainly relate to non-active implantable devices. While devices of a dubious nature classified as low-risk products, sometimes even under classified, and declared as compliant by the pass of a CE mark over which no one is effectively supervising, remain on the market.
More information:
www.flowmeter.it/
/ flow-meter-s.p.a.