First notified body EU MDR designated!

unicorn bsiBSI reports that it has achieved designation as UK notified body for the MDR. So far, it’s the first notified body to appear in the NANDO database with an MDR designation – see here for scope and here that it’s only BSI so far for the MDR (the last link is a dynamic reference to NANDO so more may appear later). The notification appears to been done before Christmas (the date in NANDO is 20 December 2018), but it always takes a few weeks to appear in NANDO.

Hurray!

This first designation is excellent news, because it shows that the designation process can deliver at least one MDR notified body. Apparently that was not enough highlight for the Commission to list it on its medical devices website or issue a press release about, but whatever – I think it’s newsworthy.

No notified body has been designated under the IVDR so far. Yet, BSI and some others did apply for MDR and IVDR simultaneously, but as is clear from the Commission’s JA status overview discussed in my last blog, the focus so far has been on the MDR. IVDR designations should hopefully follow soon as the first JAs were MDR related. Maybe also  IVDR capas take longer to correct, or notified bodies took longer to correct them and decided to focus on the MDR instead at this moment (which makes sense too).

Wait what Brexit

Less good news is that no EU27 notified bodies were accredited yet. If the no-deal Brexit that is becoming more likely by the week proceeds by end of coming March as the UK politicians decide to throw their economy under the bus, then this new MDR notified body capacity will be immediately lost again to the market. A no-deal Brexit would mean that the new UK MDR designation would not count for the EU27, unless at least something of a deal addressing the status of UK notified bodies for industrial goods is made. As said, at this point every possibility is still on the table – according to Tony even a second referendum to reverse the whole circus.

While this cloud hanging over their designation, BSI announced that they “will very shortly confirm when we will commence taking applications to the MDR.” That sounds very prudent, as the Brexit can put a serious stick in that wheel.

BSI’s Dutch notified body achieved designation under the directives as a first step to hedge for Brexit but is not yet designated under the MDR or IVDR. Hopefully that designation is also in the pipeline, as well of the designations of other notified bodies.

Stay tuned

for further developments – the next couple of months will be very very interesting for the medical devices industry with interests in the EU.

 


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