ISO 14971 :2019 - GAP-ANALYSIS résumé versus l’ancienne version ISO EN FR 14971 : 2013.

International – ISO/TR 24971:2020 – Guidance on the application of ISO 14971

This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019. The risk management process can be part of a quality...
CLASSIFICATION DES DM : Comparaison DDM/RDM

Europe – Un 4ème ON désigné pour le Règlement DMDIV

Germany’s TÜV SÜD Product Service GmbH Zertifizierstellen on Wednesday became the fourth notified body designated under the In Vitro Diagnostic Regulation (IVDR). TÜV SÜD, Germany’s second notified...
China’s NMPA Launches Voluntary Device Master File Process

China – New procedures released for medical device registration in China

China’s Center for Medical Device Evaluation (CMDE) issued two announcements recently outlining revised procedures relating to medical device registration. Increased standardization of filing review process CMDE Announcement...

Europe – NANDO : la base de données de la CE sur la règlementation...

NANDO : la base de données de la CE sur la règlementation et les organismes notifiés des DM & DMDIV...
Advice for Management of Clinical trials in relation to Coronavirus

UK – Results from laboratory-based tests for COVID-19 antibodies using capillary blood sample collection...

Laboratories offering a COVID-19 testing service for the public, private healthcare or NHS: Pause the service immediately if your service uses capillary blood samples....
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – European Commission issues decision on harmonized standards for MDR, IVDR

On May 15th, 2020, the European Commission published their Implementing Decision M/565 on harmonization of standards under the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical...

International – How regulators have adapted globally to clinical trials for drugs and biologics...

The COVID-19 pandemic has disrupted clinical trials globally and has resulted in a 65% worldwide decrease in new patient enrollment year-over-year during March 2020....

Europe – MedTech Europe guidance for assigning Basic UDI-DI

The MedTech Europe Basic UDI-DI guidance document aims to provide a framework for companies to help their Basic UDI-DI assignment. The document describes the...

Australia – Proposed delayed commencement of certain medical device regulatory changes

Reflecting the challenges identified by the medical devices industry and healthcare professionals as they have focussed on the COVID-19 crisis, the Australian Government intends...

USA – First video game-based treatment gets go ahead from FDA

A milestone for digital therapeutics was reached Monday with the US Food and Drug Administration’s (FDA) decision to grant a de novo request for Akili Interactive’s video game-based...

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