62 results

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Regulation

Posted on 02.10.2018

IVDR: The designation issue during the transitional period

The new EU In Vitro Diagnostic Medical Devices Regulation (IVDR) was published in May 2017. While the IVDR has a five-year transition period (longer than the three-year transition for the EU Medical Devices Regulation), the procedures to designate Notified Bodies (NBs) under each of these two regulations have started at the same time. NBs are […]

By Stefano Dettori Director of IVD Operative Unit of Notified Body 0373 Italian Health Institute (ISS)

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Posted on 06.09.2018

Patients & Medical technologies: why we must deepen our dialogue

As healthcare advocates, we know that dialogue between patients and the medical technology industry can deepen understanding between those who develop new healthcare solutions and those who use them. That is why our organisations, the European Patients’ Forum (EPF) and MedTech Europe, devised the Patient-Medtech Dialogue as a forum for regular interaction on topics of […]

By Nicola Bedlington Special Advisor at EPF

Health data can transform our lives – but must be used wisely
Ethics

Posted on 09.07.2018

Health data can transform our lives – but must be used wisely

This blog is part of the GMTCC 2018 blog series. You can follow the conversation under #GMTCC and find more details and at gmtcc.com. Check out related blogs: Swifter, Higher, Stronger: Promoting MedTech Ethics on the Global Stage,How to create and maintain an ethical culture,Global Responsibility, Global Ethics and Compliance, Global Principles for MedTech Innovation, Progress and […]

By Oba Adewunmi Legal Counsel at Verily Life Science

value-based procurement
Value

Posted on 19.06.2018

Case study: testing a new framework for value-based procurement

This blog is part 10 of a series on the MEAT value-based procurement project, an initiative that advocates towards a shift from price-based procurement towards value-based procurement. It does so by defining a Most Economically Advantageous Tendering (MEAT) framework that includes the value of medical technologies, services and solutions in procurement processes across Europe. Read part 1, part […]

By Gabriela Restovic Health economist

New Medical Device Regulation – an obstacle to progress
Regulation

Posted on 11.06.2018

New Medical Device Regulation – an obstacle to progress

On May 25th, 2017, a new era began. The date marks the beginning of the Medical Device Regulation, the MDR in short. It provides a new framework for the certification of medical devices in Europe and is supposed to increase the transparency of the approval and application of medical devices, as well as to improve […]

By Dr. Meinrad Lugan Member of the Management Board, B. Braun Melsungen AG

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Ethics

Posted on 24.05.2018

Progress and new challenges after 10 years of collaboration

This blog is part of the GMTCC 2018 blog series. You can follow the conversation under #GMTCC and find more details and at gmtcc.com. Check out related blogs: Swifter, Higher, Stronger: Promoting MedTech Ethics on the Global Stage, How to create and maintain an ethical culture, Global Responsibility, Global Ethics and Compliance, Global Principles for MedTech Innovation, Distributors […]

By Bronwen Taylor Vice President, Compliance & Risk Management at Stryker Corporation

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Access

Posted on 23.05.2018

Value-based procurement: a users’ guide to improving outcomes and delivering efficiencies in the UK

This blog is part 9 of a series on the MEAT value-based procurement project, an initiative that advocates towards a shift from price-based procurement towards value-based procurement. It does so by defining a Most Economically Advantageous Tendering (MEAT) framework that includes the value of medical technologies, services and solutions in procurement processes across Europe. Read part 1, part […]

By Brian Mangan FCIPS MSc Deputy Director NHS NW Procurement Development

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Regulation

Posted on 05.03.2018

Invest! Lead! Engage! Let’s Make Europe’s New Regulatory System Work

We are now over 15% of the transition period of the new European IVD Regulation (IVDR) and over 25% of the Medical Devices Regulation (MDR) transition. That said, transitioning to the new system comes with highly-ambitious timelines, and success will require great effort, by industry and authorities alike. Last week, at the Association of the […]

By Oliver Bisazza Director Regulations & Industrial Policy - MedTech Europe

ethics
Ethics

Posted on 03.05.2017

Considerations on European transparency rules for the future

Following on the footsteps of our American colleagues, MedTech Europe would like to offer some thoughts on the issue of transparency and disclosure laws and how certain adaptations could help to frame transparency for a new reality. Over the last few years, a number of European countries have passed transparency or disclosure (sometimes also called “Sunshine”) laws […]