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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

Life sciences and health care horizons 2021

Companies in the life sciences and health care industry navigated unparalleled challenges in 2020. The pandemic forced the development and adoption of new technologies and innovations...

News

The EC publishes an inception impact assessment for the proposal of a European Health Data Space

The European Commission has published an inception impact assessment for a potential legislative proposal establishing a European Health Data Space. In its document, the European Commission ...

News

Remote QMS audits under the MDR are finally allowed by the European Commission

On 11 January 2021, the European Commission published a Notice which provides the conditions under which remote audits under Regulation 2017/745 of 5 April 2017 on medical devices (MDR) and ...

Hogan Lovells Publications

European Investigations Guide 2020

Multinationals face a variety of questions when confronted with an internal investigation. Especially in Europe, cross-border investigations can be challenging to navigate as every...

News

Looking ahead to 2021: AI – A brave new world?

In recent years, AI has become a buzzword in life sciences and health care as the technology has developed to create applications from drug discovery to diagnostics to therapeutics. Most...

News

Towards a revision of current tissue, blood, and cells legislation in the European Union

On 17 November 2020, the European Commission published an inception impact assessment for a revision of the Tissue Directive and the Blood Directive. With this proposal, the European...

News

Regulation of COVID-19 Tests in the EU: when do you need to involve a Notified Body?

Since early this year, the COVID-19 virus substantially affects our daily life. Testing for the presence of or past exposure to the virus is an essential aspect of combatting the COVID-19...

News

The European Commission has published guidance on the vigilance system for insulin infusion pumps

On 6 October 2020, the European Commission published guidance on the vigilance system for insulin infusion pumps and integrated meter systems. The guidance provides an illustrative table...

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