PMS

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ENVI's amendments

ENVI’s amendments, following those of IMCO  have been published now after translation, see here for IVDs and here for medical devices. This accounts for the biggest load of the amendments (297 –…

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Guest blog: no enhanced patient safety resulting from rapporteur Roth-Behrendt's proposal

I am very pleased to publish a guest blog by Annet Muestege, director and co-founder of Applied Clinical Services BV., which dives into the clinical aspects of the DRB report proposal in…

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"P" is for Post Market Surveillance – start your engines now

I attended the Informa PMS surveillance conference in Berlin on 27 and 28 February, and thought I’d share some of the interesting things I picked up there because to me it was…

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Marketing surveillance shaping up pre-Review with Dutch Minister feedback to Dalli Action Plan

Interesting developments after the joint plan for action that Commissioner Dalli sent to the member states in the beginning of February this year urging them to step up market surveillance in order to…

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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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Outlines of the medical devices Recast become more fixed with Council conclusions

Since the High Level Meeting end of March where the Commission outlined its plans for the Recast of the Medical Devices Directive and took stock of the feelings about it in the…

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Critical analysis of the European Society of Cardiologists' report on medical devices problems, and its proposals for reform

Reader warning: this will be a longer-than-usual post, because I did not have time to write a short one (to cite the many philosophers and writers credited for this quote). The European…

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Usability engineering – how to involve users?

With the revision of the EU medical devices directive that entered into force last year stricter requirements on usability engineering have entered into force. The very first essential requirement under that directive…

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