15 results

Digital Regulation

Posted on 15.09.2022

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

As lawyers we tend to use academic journals to tease out complex legal questions. (See our latest contribution to the literature here). However, today we’re taking the opportunity to discuss a hot topic with a broader audience, as we feel it will have a profound impact on the public, patients and health systems. That topic […]

By Ulrich Juknat Legal Director Regulatory Law

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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 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 08.11.2018

The fog of war: crunch time in the regulatory cycle

As I followed the 1,075 km cycling route starting at the Belgium coast and ending in Basel, Switzerland, along the Western Front line of the First World War, I began to consider the plight of soldiers and generals a century ago. For military leaders, it was impossible to have an overview of what was happening […]

By Ronald Boumans Senior Regulatory Consultant at Emergo

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Regulation

Posted on 12.09.2018

New EU regulations: what’s next for Notified Bodies?

It is now circa ten months since any well-prepared Notified Bodies (NB) wishing to undertake conformity assessment under MDR (EU) 2017/745 and IVDR (EU) 2017/746 were able to submit formal applications.  The date of application of the MDR and IVDR, 27th May 2020, is currently 20 months away. I would like to publicly acknowledge the […]

By Gary Slack Senior Vice President Global Medical Devices, BSI Group