Medical Device News June 2024 Regulatory Update
Medical Device made Easy Podcast
English - June 06, 2024 01:48 - 53.4 MB - ★★★★★ - 18 ratingsCareers Business Education Courses medical device regulation medtech industry regulatory affairs iso mdr 2017/745 Homepage Download Apple Podcasts Google Podcasts Overcast Castro Pocket Casts RSS feed
The post Medical Device News June 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
EUROPE
EU MDR 26 May 2024 – Was there any apocalypse:
EU shortage managed – EUDAMED and IVD extension also discussed: https://www.consilium.europa.eu/en/press/press-releases/2024/05/30/medical-devices-council-adopts-new-measures-to-help-prevent-shortages/?utm_source=brevo&utm_campaign=AUTOMATED%20-%20Alert%20-%20Newsletter&utm_medium=email&utm_id=320
EMA Q&A on Combination products – Do you need a Notified Body? https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf
EU talks about SoHo -: Substances of Human Origin
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:PE_8_2024_INIT&qid=1716536451356
Italy Database error – Updating expired (AI)MDD certificates https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6569
Ireland guide on In-House IVDs – Laboratories to listen: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/guide-for-health-institutions-who-manufacture-and-use-in-house-ivds-in-ireland-v1.pdf?sfvrsn=8
Combined Studies in the EU – COMBINE PROJECT:
https://ec.europa.eu/newsroom/sante/items/830485/en
Notified Bodies
Team-NB Survey: https://www.team-nb.org/wp-content/uploads/2024/05/Team-NB-MD-Sector-Survey-PressRelease-20240515.pdf
New Notified Bodies for EU MDR –
MTIC InterCert Italy: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?organizationRefeCd=EPOS_43390&filter=notificationStatusId:1
Kiwa Istanbul: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1007731?organizationVersion=18
QMS Services GmbH Austria: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1007832?organizationVersion=1
UK
UK on international recognition – Approve products without CE or UKCA mark:
UK implementation of Future Regulation – When will this come in force: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations
UK Common Specifications for IVD – Provide your opinion: https://www.gov.uk/government/consultations/common-specification-requirements-for-in-vitro-diagnostic-devices
UK suspected counterfeit Medical Device – How to report: https://www.gov.uk/government/publications/report-a-non-compliant-medical-device-enforcement-process/report-a-non-compliant-or-suspected-counterfeit-medical-device
UK Ai Airlock – Be ready to help the government: https://www.gov.uk/government/news/mhra-launches-ai-airlock-to-address-challenges-for-regulating-medical-devices-that-use-artificial-intelligence
Webinar planned July 23rd: https://www.eventbrite.co.uk/e/ai-airlock-the-regulatory-sandbox-for-aiamd-in-healthcare-webinar-tickets-896407919217
Easy Medical Device: eQMS SmartEye
Video: One of the best eQMS for Medical Devices One of the best eQMS for Medical Devices
Events:
Medtech Conf:
Title: International Medical Device Exhibition and Conference – Subtitle: Malaysia 10th to 12th December 2024 : https://medtechconf.com/event/imdec-2024-exhibition-conference/
Training
Green Belt Training for EU MDR 2017/745 24th-28th June 2024: https://school.easymedicaldevice.com/gb/
EU Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/
WORLD
US
US Remanufacturing or Servicing – Webinar replay included:
https://www.fda.gov/media/150141/download
US – Use of Patient Generated Data – Medical Device Development: https://www.fda.gov/medical-devices/medical-devices-news-and-events/co-sponsored-public-workshop-using-patient-generated-health-data-medical-device-development-case
US Laboratory Developed Tests – Final rules defined and Webinar to explain:
Australia
Australia – in-house IVDs requirements – Support Australian Laboratories: https://www.tga.gov.au/resources/resource/guidance/regulatory-requirements-house-ivds
Australia on boundary and Combination products List: https://www.tga.gov.au/sites/default/files/2024-05/examples-boundary-combination-products-and-product-category.pdf
Saudi Arabia
Saudi Arabia – Webinar Biological Evaluation – 6 June 2024 10am Saudi Time https://www.sfda.gov.sa/en/workshop/716404
Nigeria
Guidance to register Medical Devices – Registration, labelling and advertising:
India
CDSCO laboratory testing – But in the Country and not outside: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTEzMTg=
Malaysia
Malaysia Guidance for Medical Device – Change Notification support: https://www.mda.gov.my/index.php/announcement/1401-public-comment-draft-guidance-document-change-notification-for-registered-medical-device
Hong-Kong
Overview of a Local Responsible Person – Who? What? When? Where?: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-01-E.pdf
Singapore
Singapore Cybersecurity labelling- SAt which level is your product: https://www.csa.gov.sg/our-programmes/certification-and-labelling-schemes/cls-md
PODCAST
Podcast Nostalgia – What topics were discussed
Episode 283: Quality Field Service for Medical Devices with Michael Israel: https://podcast.easymedicaldevice.com/283-2/
Episode 284: How to select and evaluate your Contract Manufacturer with Keith Smith: https://podcast.easymedicaldevice.com/284-2/
Episode 285: Are you Correction or Corrective Action or Preventive Action with Vincent Cafiso: https://podcast.easymedicaldevice.com/285-2/
Episode 286: Summative Evaluation – Common Mistakes with Amandine Broussier: https://podcast.easymedicaldevice.com/286-2/
The post Medical Device News June 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir