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Check all the links below
– A vote has been taken on the extension of the EU MDR 2017/745: https://www.raps.org/news-and-articles/news-articles/2023/2/europeanparliament-votes-to-extend-mdr-transition
-UK Impact of the extension of the transition period of medical device regulations and the validity of certified in the EU:
https://www.gov.uk/government/news/impact-of-extension-of-medical-device-regulations-transitional-period-and-thevalidity-of-certificates-in-the-eu
-Ireland – Article 97 application form: https://www.hpra.ie/homepage/about-us/publications-forms/forms-applications/item? ide4cb1326-9782-6eee-9b55-ff00008c97d0
-EU Team-NB. Best practice guidelines for submitting technical documentation for IVDR: https://www.teamnb.org/team-nb-pp-best-practice-guidance-for-the-submission-of-technical-documentation-under-annex-ii -and-iii-of-in-vitrodiagnostic-medical-devices-regulations/
-EU Team-NB. IVDR Technical Documentation Training for Manufacturers: Wednesday, June 14, 2023 https://www.teamnb.org/wp-content/uploads/members/M2023/Leaflet-IVD-TC-Manufacturers-Training-
-EMA tests scientific advice for certain high-risk medical devices: https://www.ema.europa.eu/en/news/ema-pilotsscientific-advice-certain-high-risk-medical-devices
– New Notified Bodies
NSAI for IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseactionnotification.html&ntf_id 321463&version_no10
MDC for IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseactionnotification.html&ntf_id 321397&version_no8
-Spain AEMPS: Notice addressed to notified bodies and manufacturers of nasal sprays with virucidal or microbicidal activity: https://www.aemps.gob.es/informa/la-aemps-publica-una-nota-de-aviso-dirigida-a -organismos-notificados-ya-fabricantesde-esprais-nasales-con-accion-viricida-o-microbicida/
-Swiss – Questions and answers for IVD notification:
https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_010d_mb_faq_invitro_diagnostika_meldungen.pdf.download.pdf/BW630_30_010e_MB_FAQ_Notifikationen_IVD.pdf
/search-fdaguidance-documents/guidance-industry-and-food-and-drug-administration-personnel-assemblers-guide-diagnostic-x-ray equipment
– Performance standard for diagnostic X-ray systems. https://www.fda.gov/regulatory-information/search-fdaguidance-documents/performance-standard-diagnostic-x-ray-systems-and-their-majorcomponents-21cfr-102030-102031-102032
– Medical X-ray imaging devices conform to IEC standards: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-x-ray-imaging-devices-conformance-iec-standards
-List of Cleared Companion Diagnostics: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-orapproved-companion-diagnostic-devices-in-vitro-and-imaging-tools
-American Medsun February 2023: https://www.fda.gov/media/165125/download
-SAUDI-DI Webinar March 20, 2023 https://www.sfda.gov.sa/en/workshop/87814
-Link to Webex: https://zoom.us/j/95729656046?pwdNmNOLzZYT0hmK3JqVXhPQ25LQmQ5Zz09
-Link to Webex: https://zoom.us/j/93572022832?pwdK1ZVL2xTNXFHV3NEdXVGbk4yN0Z3Zz09
-South Africa. SAPHRA Q&A on Medical Device Licensing: https://www.sahpra.org.za/wpcontent/uploads/2023/02/SAHPGL-MD-07_v3-Guideline-on-Questions-and-Answers- Licensing-of-Medical -Device-
Branches.pdf
Episode 219 – Biological Evaluation: Major Mistakes (Paul Fernandes and Laura Fouzari) https://podcast.easymedicaldevice.com/219-2/
Episode 220 – SaMD International Reach (Stephane Berger) https://podcast.easymedicaldevice.com/220-2/
Episode 221 – Prepare Your Transition from Class I to Class Ir https://podcast.easymedicaldevice.com/221-2/
LinkedIn Live – Samd Class I – To be published this week
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