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/

Czy należy ubezpieczyć nasze wyroby medyczne?

Nie jest to nowością, że sponsor i badacz w badaniu klinicznym są zobowiązani do posiadania ubezpieczenia od odpowiedzialności …

EUDAMED a informacje publiczne

Niedawno został opublikowany dokument który pokazuje w jaki sposób będzie realizowana polityka przejrzystości informacji …

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” …