MDCG Issues Guidance on Investigator’s Brochure for Medical Device Studies Learn about the latest MDCG guidance on preparing an Investigator’s Brochure for medical device studies, ensuring compliance Read more: makrocare.com/blog/mdcg-issu… #ClinicalStudies #ClinicalTrials #MDCG

Today 4 September 2024, meeting of the #MDCG Subgroup on #International matters with the European Commission EU One Health DG @SANTE services in charge of the #EU #Regulations on #MedicalDevices, the #MemberStates authorities and the sectorial #Stakeholders. See: ec.europa.eu/transparency/e…

🩺 “Passi in avanti nella valutazione dei #dispositivi orfani. Pubblicata la nuova linea guida #MDCG”. L’approfondimento della ricercatrice I-Com M.RosariaDellaPorta 👉 i-com.it/2024/08/30/pas…

A NEW SURVEY helps identify unavailabilities of #medicaldevices & #IVDs in the EU. Results will feed into the work of the #MDCG and can help address this pressing issue. 🗓️ Deadline: 30 Sept 2024 ⏳ Takes 10-20 mins to complete ec.europa.eu/eusurvey/runne…

This guidance from #NBCG-MED provides clarity on the effective implementation of hybrid audits. It incorporates feedback from the Notified Body Oversight subgroup of the MDCG and builds upon previous guidance from both the #MDCG and Team-NB. 3/5 #IVD

🔹What do #MDCG guidelines say? 🔹What are the expected data sources that need to be analysed and presented? 🔹What are the main findings that should come out of the PSUR? Join the #course and get the right information to draft a #PSUR! 👉lsacademy.com/en/product/med…

Check out the latest #Regulatorydevelopments released by the #global #HealthAuthorities and Associations - #USFDA, #ANSM, #ANVISA, #MDCG, #CTPA, etc Read through #FreyrRegulatoryRoundup. freyrsolutions.com/regulatory-rou… #RegulatoryUpdates #LifeSciences #RegulatoryRoundup #FreyrSolutions

The #MDCG has released revision 3 of their guidance document on the classification rules for #IVDs under #IVDR - MDCG 2020-16 rev. 3. It includes key changes for manufacturers, #notifiedbodies, and #health institutions involved in IVD classification. health.ec.europa.eu/document/downl…

The #MDCG has released a revised version of their guidance document on standardization for #medicaldevices: MDCG 2021-5 Rev. 1. This update incorporates important changes for manufacturers and other stakeholders in the medical device industry. health.ec.europa.eu/document/downl…

Die europäische Medizinprodukte-Regulierung ist auf dem Weg zu einem Sonderverfahren für selten angewandte Medizinprodukte #OrphanDevices einen wichtigen Schritt vorangekommen. Es gibt nun eine neue #MDCG-Leitlinie mit einer klaren Definition. Mehr: bvmed.de/pm5924

#dispositivimedici #medicaldevice #mdr #mdr745 #mdcg

#MDCG #Standards: minutes of the meeting on 13 June 2024 now published in #RegExp ec.europa.eu/transparency/e… with European Commission EU One Health DG #SANTE supporting presentation and the new MDCG 2021-5 Rev.1 Guidance on #Standardisation for #MedicalDevices health.ec.europa.eu/document/downl…

📢 MD News: el #MDCG publicó una Guía sobre estandarización para #DispositivosMédicos 💊 🎯 Su objetivo es proporcionar orientación sobre las #normas en el sector de los #ProductosSanitarios según los requisitos aplicables a la #UE. 🔗 Haz click aquí: bit.ly/3xvWM1e

The #MDCG has published a revised guidance MDCG 2022-13 Rev. 1 for all parties involved in the designation, assessment, and re-assessment of notified bodies #NBs under the #MDR and #IVDR for #medicaldevices and #IVDs. 1/4 health.ec.europa.eu/document/downl… #MedTech #Europe #NotifiedBody

MDCG amenable to data from ‘similar’ devices for orphan medical devices bioworld.com/articles/70963… #medtech #mdcg #medicaldevices

MDCG amenable to data from ‘similar’ devices for orphan medical devices bioworld.com/articles/70963… #medtech #mdcg #medicaldevices

The #MDCG has published a new guidance document MDCG 2024-10 specifically focused on the clinical evaluation of orphan devices within the framework of the #MDR. 1/5 health.ec.europa.eu/document/downl… #OrphanDevices #MedicalDevice #RegulatoryAffairs #regulatorycompliance #patientcare

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The presentation by the European Commission EU One Health DG #SANTE in support of the points in the Agenda of the #MDCG meeting on #Standards for #MedicalDevices and #InVitroDiagnosticMedicalDevices on 13 June 2024: 👇