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/

Social Media to follow

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