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Manufacturers Online Platforms Regulatory Requirements

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

Seyfarth Shaw LLP

Regulators Unveil Guidance On Best Practices for Internet Vehicle Sales

Seyfarth Shaw LLP on

Acknowledging that “[c]onsumers are clamoring for the opportunity to purchase the vehicles of their choice online because it expands the options available and enables them to save a considerable amount of time and possibly...more

Hogan Lovells

The FDA now offers cGMP Declarations

Hogan Lovells on

The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, a new online application. ...more

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