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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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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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Regulatory pathways for clean meat in the EU and the US – differences & analogies

Now that the US regulatory framework is shaping up, the analogies and differences with the European regulatory framework for market access for clean meat becomes more and more clear. This blogpost reports these analogies and differences, based on the agreement that the FDA and USDA recently concluded on their cooperation in the field of clean […]

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Cannabis derived food products – what’s the current state of play?

Recently, CBD food products were qualified as Novel Foods requiring a market authorization. The lively trade in these products therefore currently seems to be at risk. However, not all cannabis derived products…
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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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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…
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