News & Analysis as of

European Commission Regulatory Requirements Medical Devices

White & Case LLP

New EU Responsibility and Liability Landscape for Smart Medical Devices in a Global Context

White & Case LLP on

Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing less than a revolution in the art of healing. With its legislative projects on AI...more

Hogan Lovells

EU adopts restrictions on access of Chinese companies to EU public procurement for medical devices

Hogan Lovells on

Following approval by EU Member States in the Trade Barriers Committee, on 19 June 2025, the European Commission adopted the first measure (Implementing regulation - EU - 2025/1197 - EN - EUR-Lex) under the International...more

A&O Shearman

EU restricts Chinese access to public procurement of medical devices

A&O Shearman on

Last Friday, the European Commission announced its first International Procurement Instrument (IPI) measure, excluding “economic operators” from China from participation in EU public procurement procedures for medical devices...more

Knobbe Martens

European Union Votes to Curb China’s Access to Medical Device Market

Knobbe Martens on

The European Union has “agreed overwhelmingly” to limit Chinese medical device manufacturers’ access to public procurement contracts in Europe, Bloomberg reports. On Monday June 2, 2025, European Union (EU) countries...more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 121

Jones Day on

This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

White & Case LLP

First International Procurement Instrument case relating to EU medical devices in China’s public procurement market. The key...

White & Case LLP on

On 14 January 2025, the European Commission ("Commission") published the findings of its first investigation under the EU's International Procurement Instrument ("IPI"). Findings of the investigation concludes that China...more

Hogan Lovells

The European Commission issues guidance concerning management of legacy devices in EUDAMED

Hogan Lovells on

On 15 February 2021, the European Commission published guidance on the Management of legacy devices in EUDAMED. This guidance addresses the registration and identification of legacy devices in EUDAMED. Legacy devices are...more

Hogan Lovells

EU Commission adopts Communication on Brexit including anticipated changes in the health sector

Hogan Lovells on

On 9 July 2020 the European Commission adopted a Communication regarding readiness at the end of the transition period between the European Union and the United Kingdom. ...more

8 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide