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Life Sciences › Certification Requirements

Goodwin

US Emerging as Top Global Medtech Destination

Goodwin on

For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE mark certifying compliance with relevant EU health and safety standards, prior to...more

Hogan Lovells

Supplying medical devices without CE mark in the Netherlands during COVID-19

Hogan Lovells on

In response to the COVID-19 outbreak, the Dutch Healthcare and Youth Inspectorate grants manufacturers and suppliers of medical devices the temporary opportunity to supply medical devices without a CE mark or without having...more

Hogan Lovells

Appealing a denial of a drug/medical device export certificate: FDA final guidance

Hogan Lovells on

Drug and medical device manufacturers seeking to export a product from the United States may need to obtain from the U.S. Food and Drug Administration (FDA) a Certificate to Foreign Government (CFG) in order to satisfy the...more

McDermott Will & Emery

Digital Health in the United Kingdom: The New Regulatory Environment Under the Medical Device Regulation

McDermott Will & Emery on

The MDR and other recent developments in the health care regulatory landscape pose new opportunities and challenges for medical software companies and investors in digital health in the United Kingdom. Although the regulatory...more

Hogan Lovells

Navigating the U.S. FDA regulatory clearance for digital medical devices: the 510(k) and Pre-Cert program

Hogan Lovells on

Consumer demand for digital health care devices has soared, and it shows no signs of slowing down. But when bringing these devices to market, companies in the digital health space are confronted with numerous challenges. ...more

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