MEDICAL DEVICE NEWS 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-19092023160242Japan

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