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New Regulations › Risk Management › Manufacturers

Hogan Lovells

Key takeaways – UK MHRA’s response to consultation on ‘Medical Devices Regulations: Routes to market and in vitro diagnostic...

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more

Hogan Lovells

FDA finalizes cyber device “select updates” guidance, potentially affecting substantial equivalence findings for 510(k)s

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more

Littler

OSHA Renews its National Emphasis Program on Amputations in the Manufacturing Industry

Littler on

The U.S. Department of Labor’s Occupational Safety and Health Administration renewed its National Emphasis Program on Amputations in Manufacturing Industries (NEP) on June 27, 2025, superseding the prior version. This new NEP...more

Hogan Lovells

Be vigilant: new post-market surveillance requirements for medical devices in Great Britain take effect

Hogan Lovells on

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (PMSR), which were passed into law on 22 October 2024, came into force today (16 June 2025), amending the UK’s Medical...more

Shipman & Goodwin LLP

Federal Regulations Arriving ‘PFAShionably Late’ - A CBIA Manufacturing Spotlight Article

Shipman & Goodwin LLP on

A series of PFAS-related communications and rulemaking from the U.S. Environmental Protection Agency have recalibrated the agency’s focus areas and timeline under the second Trump administration. Federal PFAS regulation...more

Gardner Law

Staying Prepared Amid FDA Changes

Gardner Law on

Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...more

Akin Gump Strauss Hauer & Feld LLP

EPA Speaks on PFAS: What Manufacturers Need to Know

Akin Gump Strauss Hauer & Feld LLP on

After addressing a number of other programs over the first 100 days of the new administration, on April 28, 2025, the Environmental Protection Agency (EPA) finally addressed PFAS. Administrator Lee Zeldin outlined a number of...more

Hogan Lovells

How to leverage Advanced Purchase Agreements for military supply

Hogan Lovells on

The EU is introducing new regulations (EDIRPA and EDIP) to structure military procurement through pooled orders coordinated by the European Commission. Advanced Purchase Agreements (APAs), inspired by COVID-19 contracts,...more

Goodwin

The NIS 2 Era Is Here: Are You Compliance-Ready?

Goodwin on

With the deadline for Member States to transpose the European Union’s updated Network and Information Systems Directive (Directive (EU) 2022/2555) (NIS 2 or Directive) into national law, with the Directive having passed on 18...more

Tucker Arensberg, P.C.

Biden Warns of Imminent Cyberattacks and New Regulations– Is Your Business Prepared?

Tucker Arensberg, P.C. on

Our clients in financial services, technology, and manufacturing industries, take note of this important new piece of legislation. On March 21, 2022, President Biden warned American businesses to prepare for imminent...more

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