Area of focus

Adverse Event Reporting Vigilance Reporting

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...

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.

We regularly speak publicly on medical device reporting requirements and expectations.

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.

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.

Hogan Lovells Publications

MDR single report exemption and ASRs: Coming to an end for most reporters Medical Devices Alert

The Medical Device Reporting (MDR) regulation provides a mechanism for the U.S. Food and Drug Administration (FDA or the Agency), as well as medical device manufacturers, to identify and...

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Hogan Lovells Publications

Post-market medical devices, cybersecurity, and the U.S. FDA’s growing concerns

From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections...

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