Skip to main content

We value your privacy

We use cookies to offer you a better browsing experience and analyse our website performance. We also use third-party cookies to further customise your experience showing relevant content while you are navigating on third-party platforms.

Learn more

Regulation

Views on the rules and regulations that govern medical technologies.

Digital Regulation

Posted on 15.09.2022

Should the EU rewrite the rulebook on liability in response to advances in artificial intelligence?

By Boris Handorn, Partner

Regulation

Posted on 19.11.2021

EU move on mergers threatens innovation

shutterstock_322448540

By Aline Lautenberg, General Counsel and Director General Legal & Compliance, MedTech Europe

Regulation

Posted on 23.09.2021

Global approach needed to remote audits

shutterstock_1677538462

By Emmett Devereux, Director Government and Regulatory Affairs, Cook Medical EMEA

Regulation

Posted on 23.08.2021

The new IVD Regulation: why more time is needed to achieve success

Listen and subscribe below. The new in vitro Diagnostic Medical Devices Regulation will come into force in 2022. This new piece of legislation represents a major overhaul of the regulatory system and together with Oliver Bisazza, MedTech Europe Director General for Industrial Policies, we look into the work still needed before the IVDR comes into […]

Regulation

Posted on 27.07.2021

This is no time to further unsettle EU medtech legislation

shutterstock_322911086

Serge-Bernasconi_300dpi

By Serge Bernasconi, Chief Executive Officer, MedTech Europe

Regulation

Posted on 12.07.2021

Is medical technology innovation leaving Europe?

shutterstock_356361521

By Julia Steckeler, CEO - MedicalMountains GmbH

Regulation

Posted on 26.05.2021

MDR enters into full application and challenges remain

shutterstock_713866822

Regulation

Posted on 29.01.2020

The changing EU regulatory landscape: CE Marking for Medical Technology

Regulation

Posted on 19.08.2019

The increased role of Clinical Research Organizations in the context of the new EU regulations on medical devices

Fotolia_228889174_Subscription_Monthly_M

By Șerban Marius Roșu, Associate Professor of Medicine and Pharmacy, University of Timişoara

Regulation

Posted on 29.07.2019

Local and regional authorities are central in the European debate on health

By Valentina Polylas, Operations Manager at EUREGHA

Regulation

Posted on 05.07.2019

Are you ready for Eudamed?

Are%20you%20ready%20for%20Eudamed2

190207-0236-2 (2)

By Lionel Tussau, Director Business Development, Atrify

Regulation

Posted on 02.07.2019

From here to 2024: personalized medicine for an immediate future

By Denis Horgan, Executive Director, European Alliance for Personalised Medicine