Medical Device News December 2024 Regulatory Update

MEDBOARD: https://www.medboard.com/

EUROPE

• TEAM-NB high level position – Making Medical Devices Safer and Faster: https://www.team-nb.org/wp-content/uploads/2024/12/Team-NB-HighLevel-Strategy- PositionPaper-20241130.pdf
• –   MDCG 2024-15 – Reporting Medical Device Trials Made Easy!: https://health.ec.europa.eu/document/download/0e076d19-62dc-4ff9-83f2-be6072a45993_en? filename=mdcg_2024-15_en.pdf
• –   EMA activities on Combination products – Reminder on Drug-Device assessment.: https://www.ema.europa.eu/en/documents/presentation/presentation-sme-info-day- session-4-ema-activities-medical-devices_en.pdf

• –   MDCG 2024-16 Interruption or Discontinuation – For certain devices: https://health.ec.europa.eu/document/download/b431b10f-8512-4f47-9191-e1b84b2f9a27_en? filename=mdr_qna-article10a_mdr-ivdr_en.pdf and annex https://health.ec.europa.eu/document/download/b4a7dea7-ae73-4e13-a8a8-11dcd2678d38_en?filename=md_mdc-2024-16 _annex_en.pdf
• –   Joint Paper from 9 Member states – Council of the European Union: https://data.consilium.europa.eu/doc/document/ST-15380-2024-INIT/en/pdf
  • Reduction of Administrative Burdens
  • Centralization of System Management to the EMA
  • Predictable Certification Procedures
  • Enhanced Coordination and Support
  • Impact Assessment and Resource Allocation
• –   MDCG 2024-14 Master UDI-DI – Contact lenses: https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14 _en.pdf
  • Master UDI-DI Assignment
  • Labelling Requirements
  • Vigilance Reporting
  • EUDAMED Registration
  • Implementation Timeline
• –   Artificial Intelligence in Medical Devices . Joint publication Team NB and IG-NB: https://www.team-nb.org/wp-content/uploads/2024/11/Team-NB-PositionPaper-AI-in-MDQuestionnaire-V1-20241125.pdf
• –   Gradual Roll-out of EUDAMED – Be ready to start: https://health.ec.europa.eu/document/download/0e7327c7-0e06-4fbd-90d3-8ab7bb30fe9f_en?filename=md_mdcg_2024-11_eudamed-qa.pdf
• –   Spain application for in-house devices – For hospitals: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-una-nueva-aplicacion-para-la-comunicacion-de-fabricacion-de-productos-sanitarios-in-house-por-hospitales/

SMARTEYE

– Eqms Smarteye: https://eqms-smarteye.com/ EVENTS

– Arab Health – January 27 to 30th, 2025: https://medtechconf.com/event/total-radiology-conference/

TRAINING

• –  Mini-Course MDR: https://easymedicaldevice.com/resource/resource-medical-device-regulation/mini-course-mdr/

ROW

• –   US – Some healthcare software are not devices – WARNING: https://www.fda.gov/media/184083/download?attachment
  • Administrative support in healthcare settings.
  • Promoting healthy lifestyles without direct links to disease management.
  • Serving as electronic patient records without interpreting or analyzing data.
  • Transferring, storing, converting, or displaying medical data without interpretation.
  • Providing limited clinical decision support to healthcare providers without interpreting clinical tests or device data.
• –   US – PCCP Final guidance – Submit a PCCP with your submission: https://www.fda.gov/media/166704/download

• Webinar January 14, 2025 – https://www.fda.gov/medical-devices/cdrhnew-news-andupdates/webinar-final-guidance-marketing-submission-recommendations-predetermined-change-control-plan?utm_source=FDALinkedin

• – South Korea Guidance – Enhancing Medical Device Safety!: https://www.mfds.go.kr/law/board/boardDetail.do?menuKey=29&brdId=data0011&seq=15564

• we’re talking about new guidance from South Korea’s Ministry of Food and Drug Safety, or MFDS. They just released a document to help improve the safety and quality of
• medical devices.”
• “This guidance focuses on stricter standards for manufacturing and testing medical devices to ensure they are safe and effective for patients.”
• “The MFDS is also emphasizing the importance of proper documentation and reporting, so that any issues can be quickly identified and addressed.”
• The MFDS aims to make medical devices safer through several key measures:
• Stricter Standards: They are implementing more rigorous manufacturing and testing standards to ensure devices meet high safety and quality benc
• Enhanced Oversight: Increased oversight and regular inspections of manufacturing processes ensure compliance with safety regulations.
• Training and Education: Providing training and resources to manufacturers to help them understand and meet the new standards.
• These steps are designed to ensure that medical devices are safe, effective, and reliable for patients.
• “In short, this new guidance aims to make medical devices safer and more reliable for everyone.”

• –  Australia – Guidelines for Medical Devices – Bookmark the link: https://www.tga.gov.au/resources/resource/reference-material/australian-regulatory-guidelines-medical-devices- argmd
• –  Australia – Submit Custom-made device – Guidance step-by-step: https://www.tga.gov.au/resources/resource/user-guide/how-submit-custom-made-medical-device-notification
• –  Malaysia – Advertisement application – Approve your Advertising: https://www.mda.gov.my/index.php/industry/medical-device-advertisements/medical-device-advertisement

PODCAST

• –  How MDR and IVDR code can save you money? Stefan Bolleininger: https://podcast.easymedicaldevice.com/309-2/
• –  Is FMEA bad for your Risk Management? Rod Beuzeval: https://podcast.easymedicaldevice.com/310-2/
• –  How to build the perfect Quality Management System? https://podcast.easymedicaldevice.com/311-2/
• –  IEC 60601-1-8 How to test your Medical Device Alarms? Beat Keller https://podcast.easymedicaldevice.com/312-2/
• –  PCCP – The magic tool for planned changes in the US? Maria Diez: https://podcast.easymedicaldevice.com/313-2/

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