October 2023 Regulatory Update

EU

• Manual on Borderline and classification for Medical Devices Update – New entries to the file: https://health.ec.europa.eu/system/files/2023-09/md_borderline_manual_en.pdf
• Q&A on Annex XVI Products – Check transition timeline: https://health.ec.europa.eu/system/files/2023-09/md_new-reg_annex-xvi_q-n-a_transition-prov.pdf
• Italy: Custom-made medical device registration – Specific website available: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6352
• Ireland: Custom-made device Webinar October 19th, 2023 – Webinar to join: https://www.hpra.ie/homepage/medical-devices/news-events/item?t=/custom-made-device-(cmd)-regulation-webinar&id=5ad21426-9782-6eee-9b55-ff00008c97d0
• Team-NB – Training on MDR Technical Documentation for Manufacturers – Date of the event November 7th, 2023: https://www.team-nb.org/new-team-nb-initiative-mdr-technical-documentation-training-for-manufacturers/
  • Technical Documentation template Premium Pack: https://school.easymedicaldevice.com/product/eu-mdr-technical-file-premium-pack/
• FIMEA designate first Notified Body under the IVD regulation in Finland – EUROFINS Electric & Electronics Finland Oy: https://www.fimea.fi/web/en/-/fimea-designates-the-first-notified-body-under-the-ivd-regulation-in-finland

UK

• The innovation Devices Access Pathway (IDAP) – Pilot Phase to join – Answer before October 29th, 2023: https://www.gov.uk/government/publications/the-innovative-devices-access-pathway-idap/the-innovative-devices-access-pathway-idap-pilot-phase

CH

• Swissdamed Survey Report – The EUDAMED for Switzerland to start in 2024:  https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/infos/survey-results-report.pdf.download.pdf/20230919_swissdamed_survey%20results%20report.pdf

Conferences

Which conferences to focus on?  -I will be going to them so join me.

• MEDXD: Digitalisation of Medtech: https://medtechx.digital/
• Afrisummit in Egypt:  https://www.pharmaregafrisummit.com/
• Medica: https://www.medica-tradefair.com/
• Team-PRRC: https://www.team-prrc.eu/

Training

Trainings for you – Self-paced

• Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
• Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/

US

• US FDA – De Novo Request – Electronic Submission template: https://www.fda.gov/media/172450/download
• Webinar US FDA – Cybersecurity in Medical Devices: – November 2nd 2023: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-guidance-cybersecurity-medical-devices-quality-system-considerations-and-content
• Webinar US FDA  – Breakthrough devices program update – November 14th, 2023: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-breakthrough-devices-program-updated-final-guidance-11142023
• Digital Health FAQ – Is your medical device an SaMD?: https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-frequently-asked-questions-faqs
• ISO 10993-1:2018 versus FDA – FDA is adding its touch: https://www.fda.gov/media/142959/download
• Best practice for selecting a Predicate device for your 510K – Method provided. https://www.fda.gov/media/171838/download

Saudi Arabia

• SFDA Significant changes guidance – Template inside: https://www.sfda.gov.sa/sites/default/files/2023-09/MDS-G12a.pdf

Malaysia

• Malaysia: Workshop preparation of documents for Submission –  October 23rd, 24th and 30th: https://www.mda.gov.my/announcement/1285-first-announcement-hands-on-workshop-efficient-way-to-prepare-for-mda-documentation-submissions.html

Turkey

• Mutual Recognition of Authorized rep and NB in Turkey – Good clarification:  https://titck.gov.tr/duyuru/tcokka-mutual-recognition-of-authorized-representatives-and-notified-bodies-in-the-field-of-medical-devices-between-the-eu-and-turkiye-19092023160242

Japan

• Japan: Essential Principles – In 2023 inclusion of the Cybersecurity risks: https://www.std.pmda.go.jp/stdDB/Data_en/InfData/Infetc/MHLW_Notification_122_of_2005.pdf

India

• India: List of registered medical device testing laboratory – under Indian mdr 2017: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA1MTE=

Podcast

Podcast Nostalgia – Do you remember?

• Episode 249: Team-PRRC interviews part 1 : https://podcast.easymedicaldevice.com/249-2/
• and 250: part 2: https://podcast.easymedicaldevice.com/250-2/
• Episode 251: EUDAMED Updates: https://podcast.easymedicaldevice.com/251-2/

QMS

How Easy Medical Device can help you –easymedicaldevice.com

• We can also help you implement our eQMS – Smarteye: https://smart-eye.io