Medical Device News June 2024 Regulatory Update

https://podcast.easymedicaldevice.com...
EUROPE

EU MDR 26 May 2024 - Was there any apocalypse:

France: https://ansm.sante.fr/actualites/regl...

Netherland: https://www.igj.nl/zorgsectoren/medis...

EU shortage managed - EUDAMED and IVD extension also discussed: https://www.consilium.europa.eu/en/pr...

EMA Q&A on Combination products - Do you need a Notified Body? https://www.ema.europa.eu/en/document...

EU talks about SoHo -: Substances of Human Origin

https://eur-lex.europa.eu/legal-conte...

https://www.consilium.europa.eu/en/pr...

Italy Database error - Updating expired (AI)MDD certificates https://www.salute.gov.it/portale/new...

Ireland guide on In-House IVDs - Laboratories to listen: https://www.hpra.ie/docs/default-sour...

Combined Studies in the EU - COMBINE PROJECT:

https://ec.europa.eu/newsroom/sante/i...

https://health.ec.europa.eu/document/...

Notified Bodies

Survey Result: https://health.ec.europa.eu/document/...

Team-NB Survey: https://www.team-nb.org/wp-content/up...

New Notified Bodies for EU MDR –

MTIC InterCert Italy: https://webgate.ec.europa.eu/single-m...

Kiwa Istanbul: https://webgate.ec.europa.eu/single-m...

QMS Services GmbH Austria: https://webgate.ec.europa.eu/single-m...

UK

UK on international recognition - Approve products without CE or UKCA mark:

https://www.gov.uk/government/news/mh...

https://www.gov.uk/government/publica...

UK implementation of Future Regulation - When will this come in force: https://www.gov.uk/government/publica...

UK Common Specifications for IVD - Provide your opinion: https://www.gov.uk/government/consult...

UK suspected counterfeit Medical Device -  How to report: https://www.gov.uk/government/publica...

UK Ai Airlock - Be ready to help the government: https://www.gov.uk/government/news/mh...

Webinar planned July 23rd: https://www.eventbrite.co.uk/e/ai-air...

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-2...

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/...

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

WORLD

US

US Remanufacturing or Servicing  - Webinar replay included:

https://www.fda.gov/media/150141/down...

Webinar: https://www.fda.gov/medical-devices/m...