Medical Device News - May 2024 Regulatory Update

EU
• Notified Bodies
o TUV SUD Denmark under MDR -Welcome to the Brother or Sister: api.tech.ec.europa.eu/nando-p...
o AFNOR 46th NB under MDR -Finally a second one for France: webgate.ec.europa.eu/single-m...
• MDCG 2024-4 Guidance-Safety reporting in Performance Studies or IVD: health.ec.europa.eu/document/...
o Form: view.officeapps.live.com/op/v...
• MDCG 2024-5 Guidance - SInvestigator's Brochure for Clinical Investigation: health.ec.europa.eu/document/...
o Checklist 2024-5 health.ec.europa.eu/document/...
• Survey Article 17 - Reprocessing of single use devices: op.europa.eu/o/opportal-servi...
• Team-NB: ESMINT initiative - Call for expert: www.team-nb.org/esmint-initia...
• Spain AEMPS Bulletin on Health Products - From Jan - March 2024: www.aemps.gob.es/informa/bole...
• Germany: Classification - Bfarm to help you classify your device: www.bfarm.de/DE/Medizinproduk...
• Swiss: SaMD - information sheet to help Software companies: www.swissmedic.ch/dam/swissme...
• Turkey: 26 May 2024 - Reminder of the May 26th, 2024 deadline for EU MDR titck.gov.tr/duyuru/imalatcis...
Article to read
• European Medical Writers Association - Focus on Translation: journal.emwa.org/media/5111/m...
Training
• Training EU MDR - Green Belt Certification Program GB31 May 2024: school.easymedicaldevice.com/...
• Malaysia training - Calendar 2024: portal.mda.gov.my/index.php/d...
• Team-NB training - IVDR technical Documentation July 3rd, 2024: www.team-nb.org/fourth-sessio...
Events
• Events - Check Medtech Conf: MedtechConf.com
Rest of the world
• South Korea: Certificate Check -Verifying authenticity of certificates issued by MDFS: emedi.mfds.go.kr/msismext/emd...
• South Korea: IVD method -How to register IVD in South Korea: www.law.go.kr/%EB%B2%95%EB%A0...)
• South Korea: UDI rules to follow -Same but not the same: www.mfds.go.kr/eng/brd/m_40/d...
Mexico: Draft Mexican official standard -Labelling of Medical Devices: www.dof.gob.mx/nota_detalle.p...
• Australia: Consultation on IFU - Call for more flexibility: www.tga.gov.au/resources/cons...
Podcast
• Radiation Sterilisation Master File - Adam Issacs Rae: podcast.easymedicaldevice.com...
• What is the impact of AI Act on Medical Devices - Erik Vollebregt: podcast.easymedicaldevice.com...
• Why and how to build your Quality Culture - Lesley Worthington: podcast.easymedicaldevice.com...

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