Month: June 2020

MedTech Europe help for Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union

The “Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union” (First Edition, May 2020) is a collection of questions and answers designed to help manufacturers navigate their performance evaluation obligations under the new IVD Regulation 2017/746.

These questions and answers are the result of the collective wisdom of many regulatory and clinical experts, members of MedTech Europe and authority representatives.

MedTech Europe is committed to support the IVD industry in successfully transitioning to the IVD Regulation. This publication is being put in the public domain so that manufacturers both within and outside our membership can efficiently transition to the new Regulation in an aligned and consistent manner.

Source: https://www.medtecheurope.org/resource-library/clinical-evidence-requirements-for-ce-certification-under-the-in-vitro-diagnostic-regulation-in-the-european-union/

Po co nam kontrola zmian w wyrobach medycznych ?

Kilka słów o kontroli zmian Każda firma powinna wdrożyć swój własny system kontroli zmian oparty o wymagania prawa, …

Surowce, biokompatybilność a wyroby medyczne.

Coraz częściej w procesie projektowania wyrobów medycznych lub podczas ponownej oceny zgodności ( zmiana z MDD na …

Drug Device Combination – mała rewolucja ?

Przysłuchując się dzisiejszemu spotkaniu Multi-stakeholder webinar to support implementation of the Medical Devices Regulation …