Search Results for notified bodies

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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

EU Court of Justice Clarifies Product Liability for Notified Bodies By Michael Mezher - Published 20 February 2017

The European Court of Justice (ECJ) last week issued its long-awaited judgement on a case that heavily influenced the new revisions of the EU's Medical Device Directives.

Categories: News, Europe, EC, Medical Devices, Quality

Tags: European Court of Justice, TÜV Rheinland, PIP Breast Implants, Notified Bodies

EMA Weighs New Guideline on Quality Requirements for Combination Products By Zachary Brennan - Published 16 February 2017

The European Medicines Agency (EMA) on Thursday released for public consultation a new concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product.

Categories: News, Europe, EMA, Combination products, Quality

Tags: combination products, notified bodies, quality requirements

MHRA Looks to Increase Medical Device Fees By Michael Mezher - Published 06 February 2017

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Monday said it will move ahead with a proposal to increase and add to the fees it charges device makers and notified bodies.

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

Tags: Fees, Notified Bodies

European Regulatory Roundup: Swissmedic Clarifies Stance on EC Certificates for Devices (5 January 2016) By Nick Paul Taylor - Published 05 January 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Swissmedic, European Regulatory Roundup, notified bodies, Braille

What to do if a Device Manufacturer’s Notified Body Halts Operations? France’s ANSM Explains By Zachary Brennan - Published 14 November 2016

For several months now, notified bodies in the EU have ceased operations, either voluntarily or following a de-notification decision from their member state’s competent authority.

Categories: News, Europe, EC, Business and Leadership, Government affairs, Labeling, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: ANSM, CE marking, notified bodies

A Step Forward for New EU Medical Device Legislation By Michael Mezher - Published 22 June 2015

After weeks of heightened speculation, the European Council has agreed on its approach to new medical devices and in vitro diagnostics (IVD) legislation.

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

Tags: European Council, EPSCO Council, notified bodies, clinical investigation

EU Notified Bodies Update Code of Conduct By Stewart Eisenhart, Emergo Group - Published 16 September 2014

The European Association for Medical Devices of Notified Bodies (Team-NB) has published an updated Code of Conduct targeting more consistent and transparent CE Mark certifications from member firms.

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

Tags: Emergo Group, CE Mark, European Association for Medical Devices of Notified Bodies

MHRA Releases IVD Guidance for Notified Bodies By Alexander Gaffney - Published 10 July 2012

Categories: MHRA

Tags: Notified Bodies, Self-Testing, Latest News, IVD, guidance