Medboard Who is Medboard Medboard: https://www.medboard.com/ EU  EU Reference laboratories EURL EU Reference laboratories for IVD products: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302713 Article : https://health.ec.europa.eu/latest-updates/designation-eu-reference-laboratories-high-risk-vitro-diagnostic-medical-devices-2023-12-06_en Letter to EU Parliament  Letter sent to the European Parliament - Cybersecurity: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_17000_2023_INITMDCG 2023-7 on Clinical Investigation MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR: https://health.ec.europa.eu/document/download/1b5f9cc0-cea0-4459-921f-eaf4b4f80983_en?filename=mdcg_2023-7_en.pdf MDCG 2019-07 rev 1 on PRRC MDCG 2019-07 Rev 1: Guidance on Article 15 of MDR and IVDR on PRRC: https://health.ec.europa.eu/system/files/2023-12/md_mdcg_2019_7_guidance_art15_mdr_ivdr_en.pdf MDCG 2021-27 on Importer and Distributor MDCG 2021-27 Rev 1 Q&A Article 13 & 14 MDR and IVDR: https://health.ec.europa.eu/system/files/2023-12/mdcg_2021-27_en.pdf MDCG 2023-5 on Annex XVI class MDCG 2023-5 Guidance on qualification and classification of Annex XVI products: https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-5_en.pdf MDCG 2023-6 on Annex XVI Equivalency MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products: https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-6_en.pdf Companion Diagnostics CDx EMA Q&A on Companion Diagnostics CDx: https://www.ema.europa.eu/en/documents/other/frequently-asked-questions-medicinal-products-development-and-assessment-involving-companion-diagnostic-cdx_en.pdf Switzerland Guidance on Devices with no medical purpose Medical Device without Medical Intended Purpose: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_007d_mb_produkte_ohne_medizinische_zweckbestimmung.pdf.download.pdf/MU600_00_007e_MB_Devices_without_an_intended_medical_purpose.pdf Emergency use of non-conform device Exemption to Medical Device non-conforming: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw617_00_003d_mb-ausnahmebewilligung-mep.pdf.download.pdf/BW617_00_003e_MB%20Derogation%20MEP.pdf Notified Bodies: New Notified Body under EU MDR 43rd NB MDR - CESKY METROLOGICKY INSTITUT - Czech Republic: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=17f0c069619116060627ac0f430dff1c8cbc295c&group=NOTIFICATION&download=true Notified Body Situation Notified Body Situation; https://health.ec.europa.eu/system/files/2023-12/notifiedbodies_overview_en.pdf Training: EU MDR training Green Belt training 28th edition January 22nd until 28th https://school.easymedicaldevice.com/course/gb28/ 29th edition February 19th until 23rd https://school.easymedicaldevice.com/course/gb29/ 30th edition March 25th until 29th https://school.easymedicaldevice.com/course/gb30/   Medical Device e-Training eTraining Vigilance Reporting:  https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/ Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/   ROW Mexico: Mexico registration rules Guide for obtaining the Health Registry of Medical Devices - https://app.medboard.com/your-medboard/systematic-reviews/authorities-news/2243/ Brazil: Brazil is calling Innovative Medical Devices Innovative Medical Devices: Anvisa extends deadline for participation in pilot project: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/dispositivos-medicos-inovadores-anvisa-prorroga-prazo-de-participacao-em-projeto-piloto   Hong-Kong: Hong-Kong Guidances Artificial Intelligence Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/TR008.pdf Softwa