Publications

Hogan Lovells Publications

Podcast: Talking the cure

Our team is always thinking about how to conquer and foresee the most significant industry issues facing our clients. Over the next year, we will touch on cutting edge topics such as...

Hogan Lovells Publications

Virtual health horizons 2020

As the world responds to the COVID-19 pandemic, physicians and patients are increasingly turning to virtual health solutions, including telehealth and remote monitoring, as a central facet...

Insights

What is sufficient clinical evidence for a medical device under the EU MDR?
Registered Content

The Medical Device Coordination Group (MDCG) has issued a new document (MDCG – 2020-6) intended to provide guidance for manufacturers and notified bodies regarding the clinical...

Published Works

Implications of the one-year postponement of the application of the Medical Devices Regulation (MDR) LexisNexis

Life Sciences analysis: Regulation (EU) 2020/561 amends Regulation (EU) 2017/745, the Medical Devices Regulation (MDR) by postponing its application to 26 May 2021. Elisabethann Wright and...

News

MDCG issues guidance for ventilators and related accessories

The guidance document focuses on ventilators and related accessories that are currently regulated by the Medical Devices Directive (MDD) 93/42/EEC and intends to outline the different...

News

European Commission issues guidelines for COVID-19 in vitro diagnostic tests and their performance

On 15 April 2020 the European Commission issued guidelines regarding COVID-19 in vitro diagnostic tests. The guidelines offer an overview of the different types of test and their purposes...

News

MDCG guidance on notified body audits in the context of COVID-19 restriction measures

As a result of the COVID-19 outbreak and the associated quarantine and travel restrictions, the ability of notified bodies to conduct mandatory on-site audits under medical devices...

News

European Commission submits proposal postponing the date of application of the MDR by one year

The European Commission has submitted a proposal to the European Parliament and to the Council for a Regulation amending Regulation (EU) 745/2017 on medical devices. The purpose of the...

Hogan Lovells Publications

Cooperation in the life sciences industry and EU competition law in the context of COVID-19

The life sciences industry is facing unprecedented demands due to COVID-19. From front line carers to researchers and scientists, significant efforts are being put towards caring for those...

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