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/fi...
Q&A on Annex XVI Products - Check transition timeline: https://health.ec.europa.eu/system/fi...
Italy: Custom-made medical device registration - Specific website available: https://www.salute.gov.it/portale/new...
Ireland: Custom-made device Webinar October 19th, 2023 - Webinar to join: https://www.hpra.ie/homepage/medical-...
Team-NB - Training on MDR Technical Documentation for Manufacturers - Date of the event November 7th, 2023: https://www.team-nb.org/new-team-nb-i...
Technical Documentation template Premium Pack: https://school.easymedicaldevice.com/...
FIMEA designate first Notified Body under the IVD regulation in Finland - EUROFINS Electric & Electronics Finland Oy: https://www.fimea.fi/web/en/-/fimea-d...

UK

The innovation Devices Access Pathway (IDAP) - Pilot Phase to join - Answer before October 29th, 2023: https://www.gov.uk/government/publica...

CH

Swissdamed Survey Report - The EUDAMED for Switzerland to start in 2024:  https://www.swissmedic.ch/dam/swissme...

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/...
Audit Readiness: https://school.easymedicaldevice.com/...

US

US FDA - De Novo Request - Electronic Submission template: https://www.fda.gov/media/172450/down...

Webinar US FDA - Cybersecurity in Medical Devices: - November 2nd 2023: https://www.fda.gov/medical-devices/w...
Webinar US FDA  - Breakthrough devices program update - November 14th, 2023: https://www.fda.gov/medical-devices/w...
Digital Health FAQ - Is your medical device an SaMD?: https://www.fda.gov/medical-devices/d...
ISO 10993-1:2018 versus FDA - FDA is adding its touch: https://www.fda.gov/media/142959/down...
Best practice for selecting a Predicate device for your 510K - Method provided. https://www.fda.gov/media/171838/down...

Saudi Arabia

SFDA Significant changes guidance - Template inside: https://www.sfda.gov.sa/sites/default...

Malaysia

Malaysia: Workshop preparation of documents for Submission -  October 23rd, 24th and 30th: https://www.mda.gov.my/announcement/1...

Turkey

Mutual Recognition of Authorized rep and NB in Turkey - Good clarification:  https://titck.gov.tr/duyuru/tcokka-mu...
Japan: Essential Principles - In 2023 inclusion of the Cybersecurity risks: https://www.std.pmda.go.jp/stdDB/Data...

India

India: List of registered medical device testing laboratory - under Indian mdr 2017: https://cdsco.gov.in/opencms/opencms/...

Podcast

Podcast Nostalgia - Do you remember?
Episode 249: Team-PRRC interviews part 1 : https://podcast.easymedicaldevice.com...
and 250: part 2: https://podcast.easymedicaldevice.com...
Episode 251: EUDAMED Updates: https://podcast.easymedicaldevice.com...

QMS

How Easy Medical Device can help you -easymedicaldevice.com
We can also help you implement our eQMS - Smarteye: https://smart-eye.io​​​​​​​

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