Regulatory Survey 2024

SURVEY: Managing global regulatory strategy and compliance – assessing status, gaps, and needs.

By Celegence, MedTech Intelligence Staff

…of global compliance. MDR/IVDR remains a top priority for focus and investment. Companies lack bandwidth, yet organizations are cautious to employ external resources due to their preconceived ideas about outsourcing….

…of global compliance. MDR/IVDR remains a top priority for focus and investment. Companies lack bandwidth, yet organizations are cautious to employ external resources due to their preconceived ideas about outsourcing….

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FDA

FDA publishes long-awaited clinical trial diversity guidance

By Hogan Lovells Engage

From our publishing partner:   The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Enrollment of Participants from Underrepresented Populations in Clinical…

From our publishing partner:   The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Enrollment of Participants from Underrepresented Populations in Clinical…

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Post-market surveillance

Reliable Active Surveillance: RWE for MedTech

By Amelia Hufford, PhD, Phillip Stoltzfus

…MD. Clinical Evidence Under the EU MDR: A Notified Body Perspective. RF Quarterly. December 2023. Olivia McDermott, Breda Kearney. The value of using real-world evidence as a source of clinical…

…MD. Clinical Evidence Under the EU MDR: A Notified Body Perspective. RF Quarterly. December 2023. Olivia McDermott, Breda Kearney. The value of using real-world evidence as a source of clinical…

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Combination Devices: new guidance for industry and notified bodies

…in vitro diagnostic devices (Regulation (EU) 2017/746). These two regulations changed the European legal structure for medical devices, introducing new responsibilities and requirements for EMA and national competent authorities in…

…in vitro diagnostic devices (Regulation (EU) 2017/746). These two regulations changed the European legal structure for medical devices, introducing new responsibilities and requirements for EMA and national competent authorities in…

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CUE Health lays off entire staff

By MedTech Intelligence Staff

According to SFGate, the San Diego-based medical tech company announced Monday that it is laying off its entire staff. Similar industry reports indicate a complete shuttering of operations. Today’s announcement…

According to SFGate, the San Diego-based medical tech company announced Monday that it is laying off its entire staff. Similar industry reports indicate a complete shuttering of operations. Today’s announcement…

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Nick Recht

IQ OQ PQ and Its Role in Labeling System Validation

By Nick Recht

…to labels throughout their entire lifecycle. EU MDR: The European Union Medical Device Regulation (EU MDR) is designed to ensure public health and patient safety across Europe and to increase…

…to labels throughout their entire lifecycle. EU MDR: The European Union Medical Device Regulation (EU MDR) is designed to ensure public health and patient safety across Europe and to increase…

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Post-market surveillance

Enhancing Post-Market Surveillance: Strengthening Medical Device Regulation in the UK

By Celegence

…which received responses supporting the need for more transparent and risk-proportionate PMS requirements. Consequently, the UK MDR 2002 (SI 2002 No 618, as amended) will be amended through the Medical…

…which received responses supporting the need for more transparent and risk-proportionate PMS requirements. Consequently, the UK MDR 2002 (SI 2002 No 618, as amended) will be amended through the Medical…

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UK Flag

MHRA Announces New UK Approved Bodies

By MedTech Intelligence Staff

The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies, LNE-GMED UK and Scarlet NB UK. They join the seven current UK Approved Bodies, increasing…

The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies, LNE-GMED UK and Scarlet NB UK. They join the seven current UK Approved Bodies, increasing…

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Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership

Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership

By Celegence

Download this case study for insights on optimized regulatory processes via tech-enabled services from Celegence. Acumed made their MDR compliance a success by boosting efficiency, saving time, and streamlining collaboration….

Download this case study for insights on optimized regulatory processes via tech-enabled services from Celegence. Acumed made their MDR compliance a success by boosting efficiency, saving time, and streamlining collaboration….

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