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Medical Devices › Pharmaceutical Industry › Safety Standards

Knobbe Martens

Medical Device Cybersecurity Survey Report Released

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Cybellum released a medical device survey report on April 20, 2022 entitled “Medical Device Cybersecurity: Trends and Predictions.” The company’s website states that their “mission is to enable manufacturers and their...more

Hogan Lovells

STeP’ing up: FDA advances expedited device review program, set to begin in March

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On January 6, 2021, the U.S. Food and Drug Administration (FDA) published a final guidance outlining the Safer Technologies Program (STeP) for Medical Devices: a voluntary program for medical devices and device-led...more

Hogan Lovells

Updates on the newest regulatory legislation (Royal Decree 717/2019) in Spain

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On 5 December 2019, the Official State Gazette of Spain published a new regulation passed by the Spanish government which has introduced many significant developments in the Spanish legal framework on medicinal products for...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

FDA announces new expedited program for devices expected to significantly improve the safety of existing technologies

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On 19 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance document entitled "Safer Technologies Program for Medical Devices" (STeP), effectively following through on the...more

Foley Hoag LLP

Product Liability Update: October 2017

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Massachusetts Federal Court In Multi-District Litigation Holds Under Six States’ Laws That Manufacturer Of Brand-Name Pharmaceutical Is Not Liable For Injuries Caused By Generic Equivalents Whose Manufacturers Were Required...more

Hogan Lovells

UK MHRA Issues New Guidance on Human Factors and Usability Engineering for Medical Devices

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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on taking human factors into account when designing medical devices and ensuring that they meet the essential safety and performance...more

Robinson+Cole Health Law Diagnosis

FDA Issues Guidance on Hurricane Readiness for Medical Devices

Robinson+Cole Health Law Diagnosis on

The U.S. Food & Drug Administration (FDA) has issued important guidance on how to prepare for hurricanes when dependent on medical devices. FDA stresses that during hurricanes and other emergency situations, medical devices...more

Hogan Lovells

International Product Liability Review - Issue 65

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The International Product Liability Review provides quality updates and comment from around the world on legal developments in the field of product liability and product safety. ...more

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