Medical Device News January 2025 Regulatory Update

Medboard

EU

• EU MDR and IVDR article 10a – Discontinuation of Supply: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20250110#art_10a
• EU IVDR transition periods – Visual: https://health.ec.europa.eu/document/download/ff7fa114-c539-46b3-9066-4bfbb306e9de_en?filename=timeline_ivdr_en.pdf
• EUDAMED
• EMDN: UPDATE or not to UPDATE – MDCG 2024-2 Rev 1 and 2021-12 Rev 1 :
  • https://health.ec.europa.eu/document/download/ff8d6bf6-785f-48e1-beaf-2cfe13f59fd7_en?filename=mdcg_2025-2_en.pdf
  • MDCG 2024-2: https://health.ec.europa.eu/document/download/de470384-e8be-45e7-a334-226757f8816d_en?filename=mdcg_2024-2_en.pdf
  • MDCG 2021-12: https://health.ec.europa.eu/document/download/d90b3f63-1d62-43e6-bf5f-fb32ea7c47a2_en?filename=md_2021-12_en.pdf
• Contact points of National Authorities – Bookmark them in case: https://health.ec.europa.eu/document/download/c28e965a-3b7c-4a5b-a6ee-d1724d06f20d_en?filename=md_contact_points_of_national_authorities.pdf
• EU Battery 2023/1542 – Guidance issued by EU commission: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C_202500214
• Swiss Maintenance of Medical Devices – Guidance for Hospitals: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing—maintenance/maintenance.html
• UK timeline for UKCA – Be ready for 2030: https://assets.publishing.service.gov.uk/media/6718b88738149ce9d09e3894/Infographic_-_Devices_transition_timeline.pdf
• UK Post-Market Surveillance – Implementation and Template of PSUR: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-implementation
  • https://assets.publishing.service.gov.uk/media/67813b39363ac763c8ede498/Medical_devices_periodic_safety_update_report__PSUR__formatting__1_.pdf
  • PMS Guidance: https://www.gov.uk/government/publications/medical-devices-periodic-safety-update-report-psur/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-periodic-safety-update-reports
  • PMS Requirements: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-requirements-for-medical-devices-summary-of-main-changes
  • PMS Obligations per device type: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-pms-obligations-by-medical-device-type
• TUK Vigilance Reporting – Field Safety notices and Example of incidents: https://www.gov.uk/government/publications/medical-devices-examples-of-reportable-incidents
  • FSN: https://www.gov.uk/guidance/effective-field-safety-notices-fsns-guidance-for-manufacturers-of-medical-devices#full-publication-update-history
  • Devices for cardiac ablation: https://www.gov.uk/government/publications/reporting-adverse-incidents-devices-for-cardiac-ablation
  • Joint Replacement implant: https://www.gov.uk/government/publications/reporting-adverse-incidents-joint-replacement-implants#full-publication-update-history
  • Intraocular lenses: https://www.gov.uk/government/publications/reporting-adverse-incidents-intraocular-lenses
  • Insulin pumps and meter systems: https://www.gov.uk/government/publications/reporting-adverse-incidents-insulin-pumps-and-meter-systems
• UK guide for IVD – Learn before to re-learn: https://assets.publishing.service.gov.uk/media/67863a313ef063b15dca0f47/Guidance_on_the_regulation_of_IVD_medical_devices_in_GB.pdf

Training

• EU MDR training – Green Belt Certification Program: https://school.easymedicaldevice.com/course/gb33/

Rest of the World:

• Laboaratory Developed Tests FAQ – Learn all about LDTs: https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/definitions-and-general-oversight-laboratory-developed-tests-faqs and https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/medical-device-reporting-complaints-and-corrections-removals-reporting-laboratory-developed-tests
• How to apply your dossier in Australia – Full guidance by TGA: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/obtain-and-maintain-regulatory-evidence/australian-regulatory-evidence-options-medical-device-application/tga-conformity-assessment-certification/application-instructions-conformity-assessment
• Malaysia guidance for HIV Self-test – Placement on the Malaysia Market: https://www.mda.gov.my/index.php/documents/ukk/3480-final-gd-placement-of-hiv-self-test-kit-in-malaysia-market-2nd-edition-pdf/file
• Import Medical Device for Personnal Use in Malaysia – What means Personal use? https://portal.mda.gov.my/index.php/documents/ukk/3468-draft-public-comment-gd-importation-of-medical-device-for-personal-use-second-edition-updated-2025-pdf/file
• Alert by Philippines for Product registration – Engaging consultants is not encouraged: https://www.fda.gov.ph/wp-content/uploads/2025/01/FDA-Advisory-No.2025-0033-.pdf
• Saudi Arabia clearance of Medical Devices – For trainings or conferences: https://www.sfda.gov.sa/sites/default/files/2025-01/Guide%20to%20Conditions%20and%20requirements%20for%20Clearing%20food%2C%20Medical%20devices%2C%20and%20cosmetics%20for%20exhibitions%2C_1.pdf
• China Medical Device Regulations Round-up 2024 – Cisema.com video: 2024 Round-Up of China Medical Device regulations
• India update classification lists – List available: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTIzNDI=

Podcast

• Episode 318 – How to register a Medical Device in South Africa – Khanysile Nkuku : https://podcast.easymedicaldevice.com/318-2/
• Episode 319 – How to perform your PMS for a Drug-Device Combination – Joan D’Souza: https://podcast.easymedicaldevice.com/319-2/
• Episode 320 – Top 5 common NCs on an ISO 13485 audit: https://podcast.easymedicaldevice.com/320-2/
• Episode 321 – 6 Tips to grow as a QA RA Manager: https://podcast.easymedicaldevice.com/321-2/

The post Medical Device News January 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir