It's written in law. A medical device manufacturer must ensure that their device is safe and effective, and provides essential performance and safety, for the

It's written in law. A medical device manufacturer must ensure that their device is safe and effective, and provides essential performance and safety, for the service period defined in its instructions for use. Simple as that. Make sense to me, after working in the industry for 20 years I honestly see no need to change this. There are other things we should change, but certainly not this.