News & Analysis as of

Supply Chain European Union Medical Devices

White & Case LLP

EU imposes first International Procurement Instrument measure restricting Chinese access to medical devices procurement

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Adopted in 2022, the IPI allows the Commission to investigate alleged non-EU country measures or practices against EU economic operators that limit access to the public procurement and concession markets of non-EU countries....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

King & Spalding

EUROPE – European Commission Excludes Chinese Medical Device Manufacturers from EU Public Procurement Contracts

King & Spalding on

On June 19, 2025, the European Commission (“EU Commission”) adopted Regulation 2025/1197 imposing restrictive measures on Chinese medical devices in its first use of the European Union’s International Procurement Instrument...more

McDermott Will & Schulte

Bulletin Concurrence XII - Paris │Avril ● Mai ● Juin ● Juillet ● Aout 2024

McDermott Will & Schulte on

1. CONTENTIEUX - NOUVEAU RISQUE DE REMISE EN CAUSE À POSTERIORI D’OPÉRATIONS NON NOTIFIABLES - Par une décision du 2 mai 2024, l’Autorité de la concurrence (ci-après l’ « Autorité ») a fait pour la première fois...more

Akin Gump Strauss Hauer & Feld LLP

EU Ratifies Pioneering Artificial Intelligence Legislation

On May 21, 2024, the European Union finalized the adoption of the groundbreaking EU Artificial Intelligence Act, a comprehensive and sector-agnostic legislation that extends globally. This 420-page Act aims to regulate the...more

Hogan Lovells

EU Council approves the Batteries Regulation – what does this mean for the med tech industry?

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The new Batteries Regulation has passed the final stage of the legislative process and is expected to enter into force soon. The Batteries Regulation is part of the European Green Deal and establishes new technical and legal...more

Hogan Lovells

Medicines shortages: Dutch Ministry publishes Policy Rule; EMA calls for MAHs to register contact

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With a goal of ensuring medicinal supply interruptions are better managed, the Dutch Ministry’s Policy Rule regarding ‘iron stock’ sets obligations for marketing authorisation holders and wholesalers to keep a minimum safety...more

Hogan Lovells

Key legal concerns for advanced therapy medicinal product (ATMP) sponsors in Europe

Hogan Lovells on

In recent years we have seen more and more gene and cell therapies coming successfully to market – but many more such candidates have not made it to market, or been unable to obtain sufficient reimbursement. Gene and cell...more

Hogan Lovells

European Commission adopts a Regulation on electronic instructions for use for MDR-covered devices

Hogan Lovells on

The European Commission adopted Implementing Regulation (EU) 2021/2226 which establishes the conditions under which instructions for use of certain medical devices subject to the Medical Devices Regulation can be provided in...more

Hogan Lovells

MDCG guidance on QMS certification of distributors/importers relabeling, repackaging medical devices

Hogan Lovells on

In August 2021, the MDCG issued guidance MDCG 2021-23 for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. The...more

McDermott Will & Schulte

Investing in European Healthcare - What's on the Horizon for 2022? - Regulatory and Legal Changes

Today’s global healthcare marketplace is marked by unprecedented transformation. The seismic shifts in healthcare delivery and drug development during COVID-19 have, in 2021, continued to demonstrate the power and capacity...more

MoFo Life Sciences

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 4 Of 6)

MoFo Life Sciences on

After having dealt with the issue when software may be considered a medical device according to its intended purpose (in part 2) and the implications of the new risk classification regime (in part 3), in this part 4 of our...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, February 2021 # 12

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In Washington:  On Feb. 23, officials from five major vaccine companies will be testifying before the House Energy and Commerce Subcommittee on Oversight and Investigation.  Chairperson Diana Degette (D-CO) will be holding a...more

Hogan Lovells

The European Commission proposes a new Pharmaceutical Strategy for the EU

Hogan Lovells on

On 25 November 2020, the European Commission published a proposal for a new Pharmaceutical Strategy for Europe (“the Strategy”). The Strategy is built around four main objectives, each with an assigned work strand....more

Society of Corporate Compliance and Ethics...

A look at the EU Market Surveillance Regulation

Report on Supply Chain Compliance 3, no. 21 (October 29, 2020) - The European Union has some of the world’s most robust environmental, health and safety standards for products sold and imported into the market. Despite...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 22

Jones Day on

This regular update (no. 22 | 22 September 2020) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal...more

Hogan Lovells

European Commission issues guidance on lawful placing on the market of PPE and medical devices

Hogan Lovells on

On 18 May 2020, the European Commission issued a guidance document, regarding the verification of the lawful placing on the EU market of medical devices and personal protective equipment (PPE) in the COVID-19 context. ...more

Hogan Lovells

International products law review 2020: Issue 77

Hogan Lovells on

We're excited to bring you issue 77 of our "International products law review" with insights and updates on all aspects of products law. In this issue, provide updates on COVID-19, address promoting the circular economy...more

Hogan Lovells

Combating COVID-19: Government powers for safeguarding supply of critical products and potential conversion of production – Italy,...

Hogan Lovells on

The spread of COVID-19 is causing Europe to experience one of the greatest health crises in decades, the consequences of which are still unpredictable. Faced with this unprecedented situation, the governments of different...more

Jones Day

Trade Controls in the EU: COVID-19 Measures at a Glance

Jones Day on

In response to the novel coronavirus ("COVID-19") pandemic, the European Union ("EU"), various Member States and the United Kingdom have adopted trade control measures aimed at avoiding shortages and ensuring the availability...more

Hogan Lovells

COVID-19: Daily Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time. ...more

Hogan Lovells

An update on cooperation in the life sciences industry: the European Commission’s framework for sending “comfort letters” on...

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The European Commission has published a Temporary Framework Communication to provide guidance to companies that are cooperating to ensure the supply and distribution of essential products – including medicines and medical...more

Hogan Lovells

EU suspends tariffs on medical equipment

Hogan Lovells on

Following requests from numerous Member States, on 3 April the European Commission (“Commission“) adopted Commission Decision (EU) 2020/491 (“the Decision“), which provides for relief from import duties and VAT for goods...more

Foley Hoag LLP

COVID-19 Impacts on Trade, Export Controls, and Supply Chain

Foley Hoag LLP on

Updates from March 11 to March 25, 2020 - Key Takeaways: Supply chain disruption has begun on some fronts that are not directly related to the healthcare and medical fields, and is anticipated to continue as the effects...more

Hogan Lovells

Proposed measures in Germany for safeguarding supply of critical goods in the combat against COVID-19

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In the wake of combatting the COVID-19 pandemic, the German Federal Government is proposing to enable further measures on federal level. The proposal includes important measures concerning supply of medical devices,...more

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