Articles


Brexit is a fact – now deal with it

Following the European Parliament’s vote, the Council has now also agreed to the Brexit with its decision on the conclusion of the withdrawal agreement on behalf of the EU. The EU Parliamentarians sang off the UK members and celebrated that the…

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National MDR and IVDR implementation news – Netherlands implementation decree consultation

While nothing much comes out at EU level and member states seem to wait until the last moment with implementing legislation (because the people needed for that are caught up in the…
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National MDR and IVDR implementation news – Netherlands implementation decree consultation

While nothing much comes out at EU level and member states seem to wait until the last moment with implementing legislation (because the people needed for that are caught up in the gridlocked Brussels MDR and IVDR implementation process as a result of structural under-resourcing of medical devices oversight) some member states are really on […]

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IVDR, in-house developed tests and the state of MDR/IVDR implementation

In several posts on this blog I have discussed the severe impact that the IVDR will have on the IVD industry selling in the EU (just click on IVDR in the tag…
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This was not the Corrigendum you were looking for

So, we have had yet another couple of weeks with many things happening, so you may enjoy the two core slides from a recent presentation of mine at the NEN MDR conference…
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What to expect for 2019 with MDR and IVDR implementation?

Remember the CAMD Roadmap (dating back to end 2017) that promised us a roll-out of MDR and IVDR items that were sometimes even marked ‘high priority’ and how that lifted our spirits (at the time)? Remember how this was supplemented with the Rolling Plan, which promised the roll-out of all roll-outs for 2019? I have […]

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Don’t give me Brexit problems, give me Brexit scenarios

At the moment I spend a considerable amount of my lawyering time answering questions concerning Brexit problems. My first question back to the company is: what are your Brexit scenarios? Did you make a plan to cover the scenarios and follow through? Often the answer is “no, we don’t have a plan, because we don’t […]

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First notified body EU MDR designated!

BSI 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 –…
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MDR and IVDR in 2019: up or out, sink or swim

Happy new year and welcome to 2019, a truly decisive year for the medical devices industry with interests in the EU. If you haven’t spent any time so far getting ahead of…
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Ceci n’est pas une période de transition and first reaction to the Implant Files

As we are just past the halfway point of the MDR transitional period for the MDR and are well into the one for the IVDR there is one thing that has become very very clear:  the transitional period in the MDR and likely the one in the IVDR is not actually a transitional period for […]

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