Panoramic: Automotive and Mobility 2025
Postmarket Compliance and Enforcement Actions
- Menu
It’s a reality that medical devices intended to help patients can sometimes cause harm or malfunction. When that happens, how is your company prepared to deal with applicable regulatory requirements?
Hogan Lovells helps companies navigate the complex framework of reporting adverse events to regulatory bodies and governmental agencies related to the use of their devices. Our wealth of experience in this nuanced area allows us to help determine whether an event is reportable and to develop strategies that ensure adverse events are handled effectively, consistently, and in compliance with the law, while in certain instances seeking to develop alternative reporting approaches to streamline regulatory requirements.
We are also able to assist companies in developing remediation strategies and improvement plans where warranted.
Our capabilities at a glance
00
+
Judicial review wins
2
Ex-government policy advisors
00
+
Pieces of legislation changed
Hear from our clients and industry leaders
The whole team is super smart. They are all really easy to work with and then know our business inside out. They come to us proactively with issues and are incredibly responsive.
Chambers & Partners, UK Guide, 2025
An intellectually brilliant and commercially astute public law team. One of the very best in the city.
Chambers & Partners UK 2025
Hogan Lovells has a high capability in solving complex issues that involve both legal and technical perspectives.
Chambers & Partners, Germany, 2025
The lawyers are just experts. They are there when you need them and happy to entertain all my questions. They understand the wider context and the politics and sensitivities of it.
Chambers & Partners, UK 2025
Representative experience
We establish regulatory training programs to educate internal units of major medical device and combination product companies about adverse event reporting requirements and procedures.
We have assisted clients in responding to enforcement actions related to inadequate adverse event reporting and helped develop procedures to protect against future enforcement.
Helped clients conduct retrospective reviews of their files to assess their obligations in submitting Medical Device Reports to the FDA and bring their reporting up to date.
We regularly speak publicly on medical device reporting requirements and expectations.
Our lawyers have been named Best Lawyers of America, Washington D.C. Super Lawyers, The Legal 500 U.S. Healthcare: Life Sciences, and LMG Life Science’s Stars.
Our practice is ranked by Chambers USA as a top Healthcare: Pharmaceutical/Medical Products Regulatory practice.
Navigate change with our latest insights
