Eudamed

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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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EU Eudamed database for medical devices: La Sagrada Familia or Chartes cathedral?

I had the pleasure of presenting at the Informa Conference on the Medical Devices Directives and the Revision in Brussels today. An nice conference with a good overview of what is coming our…

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What will the Intermune and Abbvie cases mean for the medical devices industry?

I have just written annotations to the Abbvie and Intermune cases under EU pharmaceutical law for the next issue of the Dutch legal journal Jurisprudentie Geneesmiddelenrecht (in Dutch, sorry) but of course that…

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The latest on the Recast, Review, Revision of EU medical devices framework

Whenever Ms Minor from DG SANCO speaks at an event, everyone in the medical devices industry listens, hoping for new elements about where the Commission is going with the recast, review or…

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New EU guidance on medical devices vigilance reporting – more than meets the eye

The ongoing EU MEDDEV bonanza that started this January has produced yet another new document, in this case a new version of the MEDDEV 2.12/1 Medical devices vigilance system, now at revision 7….

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Update on Eudamed and its implications for vigilance in the EU

This will be a very short post, because everything I could write down on the subject is in the interview I had with Ashley Yeo of Scrip Regulatory Affairs, that kindly consented…

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Eudamed enters into full force

The European Database on Medical Devices (Eudamed) is now finally upon us. As per article 6 of the Commission Decision establishing the Eudamed database, EU member states must apply the decision as of…

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