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European Union › Manufacturers › Life Sciences

The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
Skadden, Arps, Slate, Meagher & Flom LLP

The Informed Board - Winter 2024

Skadden, Arps, Slate, Meagher & Flom LLP on

The oversight obligations of boards continue to expand. Recent enforcement actions and new laws in areas such as cybersecurity, artificial intelligence and supply chains create new challenges for boards, as we explain in this...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Hogan Lovells

Panelists discuss how European pharmaceutical companies can stay ahead of the game

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We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Zurich, where co-head of Hogan Lovells Life Sciences and Health Care sector Jane Summerfield, and partners Melissa K. Bianchi,...more

Hogan Lovells

Successful product launches across the EU, UK, and U.S.

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We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Boston for the first time since the pandemic. At the event, Hogan Lovells attorneys Eliza Andonova, Ina Brock, Kristin...more

Latham & Watkins LLP

EU MDR Transitional Provisions Officially Extended

Latham & Watkins LLP on

The revised provisions provide medical device and in-vitro diagnostics manufacturers with additional time to bring their product into compliance with the new EU Regulations, subject to a number of conditions. On March 20,...more

A&O Shearman

EU Parliament adopts amendments to EU MDR and IVDR Transition Rules

A&O Shearman on

On Thursday, the EU Parliament approved the European Commission’s proposal to extend the transition periods of the Medical Device Regulation (EU) 2017/745 (MDR). As the Council had already signalled its support, the proposal...more

Jones Day

EU Commission Proposes Extended Deadlines to Comply with the Medical Device Regulation and In Vitro Diagnostic Regulation

Jones Day on

In Short - The Situation: The transition to the new so-called Medical Device Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR"), which establish new rules for the placing on the market of medical devices...more

Hogan Lovells

Can sterile drug manufacturers implement EU GMP Annex 1 requirements before August?

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In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines that will significantly impact...more

Goodwin

The European Commission proposes to extend the transition deadline in the EU Medical Device Regulation

Goodwin on

On Friday 9 December 2022, the European Commission proposed to extend the transition deadline in the Medical Device Regulation (EU) 2017/745 (MDR). According to the European Commissioner for Health and Food Safety, Stella...more

MoFo Life Sciences

EU: In Vitro Diagnostic Regulation Entered Into Force (Part 3 Of 3)

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Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system,...more

MoFo Life Sciences

EU: IN VITRO Diagnostic Regulation Entered Into Force (Part 1 OF 3)

MoFo Life Sciences on

In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such as blood or tissue that have been taken from the human body, have become the center of attention in the public eye during the...more

Proskauer - Life Sciences

U.S. Medical Device Manufacturers Should Take Note of New European Medical Device Regulations

Proskauer - Life Sciences on

The European Union has been a leader in recent years when it comes to regulatory reform intended to protect individuals’ privacy, safety, and health. As Europe leads the way, regulators in the United States often follow suit...more

Latham & Watkins LLP

EU-UK Trade and Cooperation Agreement: Implications for Life Sciences Companies

Latham & Watkins LLP on

The agreement provides guidance across several areas for the life sciences sector, though gaps remain. The widely anticipated EU-UK Trade and Cooperation Agreement (the Agreement) came into effect on 1 January 2021 after...more

Hogan Lovells

IoT in the EU: Lessons from COVID-19, and next steps for liability and regulation

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The IoT sector has exploded over the past few years, and, even taking into account the globally inhibitive effects of COVID-19, this growth shows few long-term signs of abating. The buoyant, fast-paced IoT industry was the...more

Hogan Lovells

EMA publishes guidance providing regulatory adaptations for MAHs in the context of COVID-19

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On 10 April 2020, the European Commission, the EMA and the European medicines regulatory network published a notice providing guidance to stakeholders regarding regulatory expectations for medicinal products for human use...more

Hogan Lovells

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

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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

Orrick - On the Chain

At Your Service: First-Ever On the Chain Survey Reflects a Steady Rise in Blockchain Awareness, Acceptance and Adoption

Orrick - On the Chain on

The results are in! Responses to Orrick’s first survey of the dedicated followers of On the Chain, our blockchain blog, revealed at least two things: (1) that blockchain technology is continuing to gain acceptance in and...more

Robins Kaplan LLP

Financial Daily Dose 12.02.2019 | Top Story: US Restores Metal Tariffs on Argentina and Brazil

Robins Kaplan LLP on

The White House will again slap tariffs on steel and aluminum imports from Argentina and Brazil in an apparent reaction to “massive devaluation” of  currencies in both South American nations....more

Hogan Lovells

New MDCG Guidance on Summary of Safety and Clinical Performance under the Medical Devices Regulation (MDR)

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On 26 September 2019, the European Commission published a new Guidance of the Medical Device Coordination Group (MDCG) concerning the Summary of Safety and Clinical Performance (SSCP). This document is aimed at manufacturers...more

Hogan Lovells

European Commission draft implementing regulation on the reprocessing of single-use medical devices: public consultation is open!

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On 23 July 2019, the European Commission published the draft Commission Implementing Regulation (hereafter “Draft”) regarding Common Specifications for the reprocessing of single-use medical devices....more

McDermott Will & Emery

European SPC Manufacturing Waiver Goes into Force

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Newly issued EU Regulation 2019/933 provides supplementary protection certificate exemptions for exporting and stockpiling active pharmaceutical ingredients and medicinal products if certain anti-abuse requirements are met....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

New Brexit Q&A provides several examples in relation to the “placing on the EU market” of products including medical devices

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On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more

Hogan Lovells

EU: New developments in the SPC manufacturing waiver legislative process

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Following the European Commission’s draft proposal for implementing the so-called SPC manufacturing waiver the Committee on Legal Affairs of the European Parliament published a draft report on presenting its suggested...more

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