News & Analysis as of September 17, 2024

Regulatory Oversight

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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 -

Analyzing the EU Artificial Intelligence Act: Spotlight on Biometrics

Baker Donelson on 5/17/2024

The European Parliament formally adopted the EU Artificial Intelligence Act (AI Act), a first-of-its-kind comprehensive regulation governing the use of artificial intelligence (AI), on March 13, 2024. While applicable to a...more

Acquiring or Investing in EU Crypto-Asset Businesses: Further Clarity on MiCA

Goodwin on 4/18/2024

In our previous alert “Acquiring or Investing in EU Crypto-Asset Businesses: MiCA’s Impact,” we discussed the impact of the European Union (EU) Markets in Crypto-Assets Regulation (MiCA) on the acquisition or investment in EU...more

To Boldly Go Places: EU's AI Act is Set to Become the Real Deal

Baker Donelson on 12/14/2023

On December 8, 2023, EU policymakers reached an agreement on the Artificial Intelligence Act (AI Act). As a standard-bearer for global digital and data governance, the EU has been setting regulatory benchmarks on emerging...more

New Medical Devices Regulation in Spain

Hogan Lovells on 3/27/2023

On 23 March 2023 the new Spanish Medical Devices Regulation (Spanish MDR) came into force. After a lengthy wait, the medical devices industry (and any other interested sector) finally has access to the final text and knows...more

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

Hogan Lovells on 1/17/2023

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

Buying a UK Crypto Business: The New Regulatory Hurdles

Goodwin on 9/21/2022

The advance of the regulation of crypto-assets and crypto-related service providers has been piecemeal in the U.K. The latest round of changes took place in the Money Laundering Regulations 2017 (MLR) on 1 September...more

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

Hogan Lovells on 6/3/2022

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

Draft text of new Spanish regulation on medical devices is opened for contributions

Hogan Lovells on 6/15/2021

The Spanish Ministry of Health has initiated the hearing and public information process for the new regulation on medical devices. The draft text will be available for contributions by 10 July 2021. The direct application of...more

The European Commission proposes a new Pharmaceutical Strategy for the EU

Hogan Lovells on 12/8/2020

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

European Commission announced its plan to postpone the implementation of the MDR by one year

Hogan Lovells on 3/30/2020

The European Commission today announced that it is preparing a proposal to postpone the entry into application of the new Medical Devices Regulation (MDR). The proposed postponement would be for one year....more

New medical device regulation in Spain opened for public consultation

Hogan Lovells on 3/3/2020

Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more

Gearing up for enhanced consumer protection: the impact of the EU's new rules

Hogan Lovells on 2/27/2020

On 7 January 2020, Directive (EU) 2019/2161 (the "Directive") came into force, setting into motion a swathe of measures aimed at modernizing the existing consumer protection rules, bolstering the level of protection available...more

Food & Beverage Litigation Update l December 2019

Shook, Hardy & Bacon L.L.P. on 12/9/2019

LEGISLATION, REGULATIONS & STANDARDS - FDA Issues Warning Letters, Consumer Update On CBD, Sparking Litigation Against CBD Cos. - The U.S. Food and Drug Administration (FDA) has issued a consumer update on cannabidiol...more

Food & Beverage Litigation Update l November 2019 #2

Shook, Hardy & Bacon L.L.P. on 11/18/2019

LEGISLATION, REGULATIONS & STANDARDS - USDA Receives Hundreds Of Comments On Hemp Interim Rule - Two weeks after opening a comment period on an interim final rule on hemp farming, the U.S. Department of Agriculture...more

A Turning Point for Tech – Global survey on digital regulation

Hogan Lovells on 10/31/2019

Whilst political uncertainty may have businesses’ attention fixed, the Hogan Lovells Global Survey on Digital Regulation: ‘A Turning Point for Tech’ suggests that tech companies should be looking elsewhere. During yesterday’s...more

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

Hogan Lovells on 9/30/2019

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

European Banking Authority Publishes Question and Answer Relating to Originator Risk Retention Holders in Securitisations

Cadwalader, Wickersham & Taft LLP on 9/17/2019

On 13 September 2019, the European Banking Authority (the “EBA”) updated its guidance in respect of the Securitisation Regulation[1] by publishing an answer to a question submitted to it in November 2018 by the Association...more

Publication of rules on designation of expert panels under the Medical Devices Regulations

Hogan Lovells on 9/13/2019

In the process of getting ready for the implementation of the forthcoming medical devices Regulations the European Commission published on 10 September 2019 the Commission Implementing Decision (EU) 2019/1396 (Decision)...more

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

Hogan Lovells on 8/8/2019

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

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European Union › Regulatory Standards › Regulatory Oversight

Analyzing the EU Artificial Intelligence Act: Spotlight on Biometrics

Acquiring or Investing in EU Crypto-Asset Businesses: Further Clarity on MiCA

To Boldly Go Places: EU's AI Act is Set to Become the Real Deal

New Medical Devices Regulation in Spain

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

Buying a UK Crypto Business: The New Regulatory Hurdles

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

Draft text of new Spanish regulation on medical devices is opened for contributions

The European Commission proposes a new Pharmaceutical Strategy for the EU

European Commission announced its plan to postpone the implementation of the MDR by one year

New medical device regulation in Spain opened for public consultation

Gearing up for enhanced consumer protection: the impact of the EU's new rules

Food & Beverage Litigation Update l December 2019

Food & Beverage Litigation Update l November 2019 #2

A Turning Point for Tech – Global survey on digital regulation

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

European Banking Authority Publishes Question and Answer Relating to Originator Risk Retention Holders in Securitisations

Publication of rules on designation of expert panels under the Medical Devices Regulations

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

European Product Liability Directive: Stay tuned, guidance is around the corner

A Year of GDPR: Five Recommendations to Help Limit Regulatory Scrutiny

Brexit snapshot: Medical Devices

EU and Japan Create World’s Largest Area of Safe Data Transfers

New Belgian legislation on the distribution of medical devices

European Commission publishes factsheet on the (in vitro) medical devices procurement ecosystem

European Union › Regulatory Standards › Regulatory Oversight

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