Regulation

Views on the rules and regulations that govern MedTech.

95 blogs about the topic

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Regulation

Posted on 19.11.2021

EU move on mergers threatens innovation

At first sight, EU policy on mergers and acquisitions might not need to concern patients and frontline healthcare workers too much. However, a subtle shift in the rules on whether two companies can agree to become one could have a profound impact on access to medical innovation. To understand why this might be, it’s important […]

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

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Regulation

Posted on 23.09.2021

Global approach needed to remote audits

The pandemic has changed many aspects of our lives. This is no different for those of us in the medtech space where we were pushed to rethink how we work. In the process, we learned how to find robust alternatives to important processes such as physical audits. These changes also revealed the need for greater […]

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

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Regulation

Posted on 27.07.2021

This is no time to further unsettle EU medtech legislation

Policymakers spent years on agreeing on one of the most modern medtech rules in the world – this should not be undermined by revisions to horizontal legislation. As Brussels powers down for a short summer lull, I find myself in a reflective mode. The pandemic has transformed our lives – suffice to say that we […]

By Serge Bernasconi Chief Executive Officer, MedTech Europe

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Regulation

Posted on 12.07.2021

Is medical technology innovation leaving Europe?

On 26th of May 2021 the EU Medical Device Regulation (MDR) became fully applicable. It is a modern piece of legislation that strives to ’establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation’. It further aims ’to ensure the smooth […]

By Julia Steckeler CEO - MedicalMountains GmbH

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Regulation

Posted on 26.05.2021

MDR enters into full application and challenges remain

After 4 years of transition period followed by a pandemic year, we reached the date of application of the medical device regulation 2017/745 on May 26, 2021. A lot of uncertainty is still associated with this date and key stakeholders are still questioning the readiness of the system. Twenty notified bodies out of fifty applicants […]

By Bassil Akra CEO - QUNIQUE GmbH

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Regulation

Posted on 19.08.2019

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

In 2017 the European Commission changed and updated the legal framework regarding the medical devices, superseding the existing directives, with two new regulations which added new responsibilities for European Medicines Agency and national regulatory authorities. The two new regulations, the MDR 2017/745 on medical devices and IVDR 2017/746 on in vitro diagnostic devices are scheduled […]

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

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Regulation

Posted on 29.07.2019

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

Since January 2018 I am working for EUREGHA – European Regional and local health authorities– a Brussels-based association representing the interest at EU level of 15 regions coming from 10 countries across Europe. This vibrant network made me positively discover how local and regional health authorities are becoming more and more interested and engaged in […]

By Valentina Polylas Operations Manager at EUREGHA

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Regulation

Posted on 05.07.2019

Are you ready for Eudamed?

We all know that the healthcare landscape is undergoing significant transformation. Today’s patients and clinicians are savvy consumers, demanding access to trusted product information to make informed decisions about health care. In parallel, government organisations are supporting patient safety through regulatory mandates around product traceability. To me, one of the biggest changes on the horizon […]

By Lionel Tussau Director Business Development, Atrify

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Regulation

Posted on 02.07.2019

From here to 2024: personalized medicine for an immediate future

State of play The aim of Europe’s policies and actions in public health is to improve and protect human health, and to support the modernisation of Europe’s health systems – which the EU sees both as improving the quality of its citizens’ lives, and as a contribution to goals involving growth and jobs. While the […]

By Denis Horgan Executive Director, European Alliance for Personalised Medicine