Medical Device News June 2024 Regulatory Update

podcast.easyme...
EUROPE
EU MDR 26 May 2024 - Was there any apocalypse:
France: ansm.sante.fr/...
Netherland: www.igj.nl/zor...
EU shortage managed - EUDAMED and IVD extension also discussed: www.consilium....
EMA Q&A on Combination products - Do you need a Notified Body? www.ema.europa...
EU talks about SoHo -: Substances of Human Origin
eur-lex.europa...
www.consilium....
Italy Database error - Updating expired (AI)MDD certificates www.salute.gov...
Ireland guide on In-House IVDs - Laboratories to listen: www.hpra.ie/do...
Combined Studies in the EU - COMBINE PROJECT:
ec.europa.eu/n...
health.ec.euro...
Notified Bodies
Survey Result: health.ec.euro...
Team-NB Survey: www.team-nb.or...
New Notified Bodies for EU MDR -
MTIC InterCert Italy: webgate.ec.eur...
Kiwa Istanbul: webgate.ec.eur...
QMS Services GmbH Austria: webgate.ec.eur...
UK
UK on international recognition - Approve products without CE or UKCA mark:
www.gov.uk/gov...
www.gov.uk/gov...
UK implementation of Future Regulation - When will this come in force: www.gov.uk/gov...
UK Common Specifications for IVD - Provide your opinion: www.gov.uk/gov...
UK suspected counterfeit Medical Device - How to report: www.gov.uk/gov...
UK Ai Airlock - Be ready to help the government: www.gov.uk/gov...
Webinar planned July 23rd: www.eventbrite...
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 : medtechconf.co...
Training
Green Belt Training for EU MDR 2017/745 24th-28th June 2024: school.easymed...
EU Vigilance Reporting: school.easymed...
Audit Readiness: school.easymed...
WORLD
US
US Remanufacturing or Servicing - Webinar replay included:
www.fda.gov/me...
Webinar: www.fda.gov/me...