Medical Device News: February 2023 Regulatory Update
Your Medical Device News is ready for the month of February 2023. This is containing some information on the extension of the EU MDR timeline so don't miss it. The post Medical Device News: February 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device made Easy Podcast
February 6, 2023
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Show Notes
Here is your Regulatory Update for the month of February 2023. Check all the links below
| – EU amendment of the EU MDR and IVDR: https://health.ec.europa.eu/medical-devices-sector/new-regulations_en – Proposal for extension consultation: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13684-Medical-devices-transition-period-extension_en – Q&A: https://ec.europa.eu/commission/presscorner/detail/en/QANDA_23_24 – General Secretariat: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_5585_2023_INIT – Vote: https://eur-lex.europa.eu/procedure/EN/2023_5?qid=1675093438485&rid=1 |
| – EU list of Standard Fees for Notified Bodies: https://health.ec.europa.eu/latest-updates/mdcg-2023-2-list-standard-fees-january-2023-2023-01-12_en |
| – EU Delegated directive for exemption for lead as a thermal stabilizer in Polyvinyl Chloride used as base material in sensors used in in-vitro diagnostic medical devices: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13594-Electrical-equipment-lead-in-polyvinyl-chloride-for-sensors-used-in-diagnostic-medical-devices-RoHS-exemption-_en |
| – MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of EU MDR and IVDR: https://health.ec.europa.eu/system/files/2023-01/mdcg_2023-1_en.pdf |
| – Annual overview of devices subject to the clinical Evaluation Consultation Procedure (CECP): https://health.ec.europa.eu/latest-updates/annual-overview-devices-subject-clinical-evaluation-consultation-procedure-cecp-april-2021-june-2022-2023-01-23_en |
| – Training EU MDR 2017/745: https://school.easymedicaldevice.com/course/gb24 |
| – UK government response to the consultation on Medical Device Regulation: https://www.gov.uk/government/publications/government-response-to-the-rhc-report-on-medical-devices |
| – UK MHRA increases UK assessment capacity for In-Vitro diagnostic devices: https://www.gov.uk/government/news/mhra-increases-uk-assessment-capacity-for-in-vitro-diagnostic-devices |
| – Saudi Arabia: Guidance AI/ML Software based: https://www.sfda.gov.sa/sites/default/files/2023-01/MDS-G010ML.pdf |
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The post Medical Device News: February 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Topics
medicaldeviceregulationMEDTECHINDUSTRYregulatoryaffairsISO13485EUMDRMDR2017/745MedicalDeviceIndustryQualityManagementSystemFDAANVISATGAEURegulatoryComplianceAuditsNotifiedBodymeddevicetrainingcertificationbusinesstechnolo