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Healthcare › Regulatory Oversight › European Union

McDermott Will & Schulte

Partnering with Legal at the Critical AI/Healthcare Crossroads

McDermott Will & Schulte on

The intersection of AI and healthcare is outpacing the development of laws and regulations governing the technology. Even in the early days of AI transformation, this is creating uncertainty for healthcare organizations....more

Sheppard Mullin Richter & Hampton LLP

Recent Healthcare-Related Artificial Intelligence Developments

Sheppard Mullin Richter & Hampton LLP on

AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down. From a governmental perspective, many federal agencies are embracing...more

Hogan Lovells

New Brexit Q&A provides several examples in relation to the “placing on the EU market”of products including medical devices

Hogan Lovells on

On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more

Hogan Lovells

European Commission publishes factsheet on medical devices and in vitro medical devices for non-EU and non-EEA competent...

Hogan Lovells on

Introduction The European Commission has published a factsheet addressed to competent authorities of third countries....more

Hogan Lovells

EMA publishes draft Guideline on clinical investigation of haemophilia B medicinal products

Hogan Lovells on

Introduction The EMA has published a draft Guideline on clinical investigation of recombinant and human plasma-derived factor IX products....more

Hogan Lovells

The European Commission publishes nine new guidance documents in relation to the MDR and IVDR

Hogan Lovells on

On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in relation to the Medical Devices Regulation (“MDR”) and In vitro Diagnostic...more

Hogan Lovells

EMA warns marketing authorisations holders to notify type I variations earlier

Hogan Lovells on

On 26 October 2018, the European Medicines Agency (EMA), advised marketing authorisation holders to submit type I variations prior to the temporary closure of the EMA. The EMA will relocate from London to Amsterdam and will...more

Hogan Lovells

European Commission invites targeted stakeholders for consultation on duplicate marketing authorisations for biological medicinal...

Hogan Lovells on

The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorisations from stakeholders....more

Carlton Fields

What’s Your Game Plan? Offensive or Defensive: Playing to Your Strengths [Expect Focus – October 2016]

Carlton Fields on

- AXA Prevails at First Post-Jones v. Harris Excessive Fee Trial - Potential Secondary Effects of Regulatory Examinations: Evidentiary Issues and Preclusion in Parallel Litigation - On The Horizon: Global...more

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