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Medical Devices › Online Platforms

Hogan Lovells

New MDCG guidance clarifies rules for medical device software available on online platforms

Hogan Lovells on

The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the regulatory roles of online...more

Hogan Lovells

Directive for the supply of digital content and digital services to consumers: Spain update

Hogan Lovells on

Spain has just passed the law transposing Directive (EU) 2019/770 on certain aspects concerning contracts for the supply of digital content and digital services ("Directive 2019/770"). This Directive has updated and brought...more

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - October 2018

Robinson & Cole LLP on

On October 1, 2018, the Food and Drug Administration (FDA) issued its “Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook” to address continued threats to medical devices that could affect...more

BakerHostetler

FDA Allowing Additional Comment Period for Draft Social Media Guidances

BakerHostetler on

The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional time to allow interested persons to submit comments. Beginning September 29,...more

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