mdr xb950怎么设置中文

now let's talk a little bit about what the eu medical devices regulation really is so the mdr is the regulatory approval framework for medical devices that are being placed on the market within the european union now， this excludes in vitro devices as those are covered by a separate regulation and we'll talk about that in the next slide now， this is a very large regulation it's not you know as small as some of the other ones that we've seen， but it's also not as large as a reach regulation so at least there's that， but we're still talking about a hundred and twenty three articles in ten chapters， seventeen， annexes and a hundred and seventy five pages so this is not something that you can quickly and easily come up to speed on it something is going to take some time to learn and analyze and prepare for looking a little bit at the timeline here the regulation was adopted on april， fifth twenty seventeen and published into the official journal on may fifth twenty seventeen now as with most european regulations that are public in the official journal it became effective twenty days after publication， which means that became effective on may twenty fifth twenty seventeen so what we see here though is that we talked about how in vitro devices are not included within the scope of this regulation and that's because it was released with its sister regulation the ivdr or the in vitro medical device regulation and what the ivdr does is it kind of separates in vitro equipment requirements so we don't have to consider those for the mdr and this is important because as you can see down below the mdr has a three year transition while the ivdr has a five year transition on april twenty third twenty twenty the european council and parliament adopted regulation twenty twenty five six one amending the european medical devices regulation to postpone the application dates for most provisions by one year until may twenty twenty one the i v d r application date remains the same， so this is why today we're focusing on the mdr because the medical device's regulation is going to hit us first right， and it's the most critical one that get up to speed on we'll have a little bit more time to address the invito devices， but for now we're going to focus on mdr so when we look at okay， so the mdr we have the timeline， but how does it relate to the existing regulations we're currently working with well companies that make medical devices right now are probably either working with either the medical device directive or the active implantable medical device directive depending on what type of product it is now the mdr is going to replace both of these so in the regardless of which directive you're using you're going to have to move to the new mdr moving forward the ivdr， which is the one that comes into effect two years later is replacing the nvito diagnostic medical devices directive so it's basically replacing the previous version of itself notice that these are regulations though they're not directives they're replacing directives， but they're there's a little bit of it indifference from a enforcement perspective and a management perspective and that a directive is actually just that it's a directive by the european union and all the individual member states within the union then have to enact national legislation which is the actual laws that you mean right so directive isn't a law it's a directive further the member states to create laws whereas a regulation is actually a eu centric law and can be enforced at the eu level okay， so there's a big difference between directives which are legislated and enforced at the member state level versus regulations which are legislated and enforced at the eu level now of course a member states of the responsibility of enforcing those， but it just kind of a legal difference now when we look at the existing certificates we have for the mdd the aimd or the ivm dd， even we can see that we can use those to place park products on the market and still twenty twenty four so we saw when we go back here we saw that well mdr becomes mandatory in twenty twenty three year transition right， but we have until twenty twenty four to use those a place them on the market that's because these certificates have a life span right， they're good for four or five years sometimes， so， that's why that is in place right because you get to play out the certificates so they'll stop issuing the certificates， but you have to stop using them for placing on the market by may of twenty twenty four and then you can no longer use those certificates to place products and service after twenty twenty five like for high risk items right， so there's two sets of dates that we're tracking here with our win the certificates themselves are no longer are applicable to be used and when you can actually get their certificates which is what the implementation dates we see here learn more by viewing the full length video online at 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