Search Results for IVDR

Showing 1 – 11

The Medical Device Coordination Group: a new Authority Under EU Device Regulations By Robert D. Cumming, Nancy W. Mathewson, Esq. - Published 14 November 2017

This article discusses the organization and functions of the Medical Device Coordination Group (MDCG) established under the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The article explains how both groups will be important players in the conformity assessment body 'notification' process and in determining how notified bodies assess and certify devices and in serving as a reviewing body for making regulatory and jurisdictional decisions for the European Commission.

Categories: Features, Europe, EC, In vitro diagnostics, Medical Devices

Tags: MDR, IVDR, Medical Device Coordination Group, MDCG

MDR, IVDR: Competent Authorities Lay Out Road Map By Zachary Brennan - Published 13 November 2017

The Competent Authorities for Medical Devices (CAMD) Executive Group’s EU medical device regulation and in vitro diagnostic regulation (MDR/IVDR) implementation task force has released a road map outlining key challenges and steps for various technical work streams.

Categories: News, Europe, EC, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: MDR, IVDR, CAMD

Notified Bodies Disclose Re-Designation Intentions Ahead of EU MDR, IVDR Deadline By Zachary Brennan - Published 08 November 2017

European notified bodies are prepping for a 26 November deadline and announcing their intentions to apply for designation as implementation of the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) continues.

Categories: News, Europe, EC, In vitro diagnostics, Medical Devices, Regulatory intelligence

Tags: notified bodies, Team-NB, MDR, IVDR

First Implementing Act Under EU MDR, IVDR Open for Consultation By Zachary Brennan - Published 20 October 2017

The first implementing act for the EU’s new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) is open for comments until next Wednesday.

Categories: News, Europe, EC, In vitro diagnostics, Medical Devices

Tags: MDR, IVDR, medical device regulations Europe

MHRA Offers Interactive Guide on New EU Device, IVD Regulations By Zachary Brennan - Published 29 August 2017

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released an introductory guide to help medical device manufacturers understand their obligations under the new EU regulations for medical devices (MDR) and in vitro diagnostic devices (IVDR).

Categories: News, Europe, EC, MHRA, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: MDR, IVDR, EU device regulations

European Regulatory Roundup: EU Device Regulations Come Into Force; Swissmedic Clarifies Pharmacovigilance Process (1 June 2017) By Nick Paul Taylor - Published 01 June 2017

The European Union medical device and in-vitro diagnostic (IVD) regulations have come into force. The passing of the date marks the start of the phased, multi-year introductions of requirements set out in the two documents.

Categories: Europe, EC, EMA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Postmarket surveillance, Submission and registration

Tags: European Regulatory Roundup, Regulatory Roundup, EU Regulatory Roundup, Brexit, MDR, IVDR, Swissmedic, Pharmacovigilance,

Final EU MDR, IVDR Texts Published, Countdown to Implementation Begins By Zachary Brennan - Published 05 May 2017

The final texts of the new European medical device and in vitro diagnostic (IVD) regulations were published on Friday in the Official Journal of the European Union, setting in motion the timeline for implementation of the new regulations, which is set to commence on 25 May.

Categories: News, Europe, US, EC, In vitro diagnostics, Medical Devices

Tags: EU MDR, IVDR, new medical device regulations, Europe regulations

EU Parliament Adopts New Medical Device, IVD Regulations By Michael Mezher - Published 05 April 2017

The EU's effort to overhaul the regulation of medical devices and in vitro diagnostics (IVDs) has cleared its final legislative hurdle after the European Parliament on Wednesday adopted the proposed regulations without amendment, voting down a proposal from the UK Independence Party to reject the regulations.

Categories: News, Europe, EC, In vitro diagnostics, Medical Devices, Postmarket surveillance, Submission and registration

Tags: MDR, IVDR, European Parliament

EU Council Unanimously Adopts MDR, IVDR: Next Stop EU Parliament By Michael Mezher - Published 07 March 2017

The EU's new rules governing medical device and in vitro diagnostics (IVDs) are one step away from being fully adopted.

Categories: News, Europe, In vitro diagnostics, Medical Devices

Tags: Medical Device Regulations, MDR, In Vitro Diagnostics Regulations, IVDR, EU Council

IMDRF Offers a Preview of Next Week’s Vancouver Meeting By Zachary Brennan - Published 06 March 2017

Members of the International Medical Device Regulators Forum (IMDRF) will meet next week in Vancouver for the group’s 11th meeting. Presentations on updates from members located in the US, EU, Brazil, Australia, as well as updates on IMDRF working groups were unveiled recently.

Categories: News, Asia, Canada, Europe, US, Anvisa, EC, FDA, IMDRF, TGA, WHO, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: IMDRF, MDR, IVDR, MDUFA, Cures

MDR and IVDR: the Potential for a 28-Agency, 22-Language Regulatory Process for Medical Devices in the EU By Rod Ruston - Published 03 March 2017

This article provides detail in the MDR and IVDR which seems to have escaped observation. Yet, the detail could have far-reaching implications. What follows is in both the MDR and IVDR, and so in the pursuit of clarity, all references are restricted to the MDR.

Categories: Features, Europe, EC, In vitro diagnostics, Medical Devices, Submission and registration

Tags: Medical Device Regulation, In Vitro Diagnostic Medical Devices Regulation, MDR, IVDR