Medical Device News: March 2023 Regulatory Update

Here is your Regulatory Update for the month of March 2023. Check all the links below

- EU MDR 2017/745 extension has been voted: https://www.raps.org/news-and-articles/news-articles/2023/2/europeanparliament-votes-to-extend-mdr-transition

-UK Impact of extension of Medical Device Regulations transitional period and the validity of Certificated 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 request form : https://www.hpra.ie/homepage/about-us/publications-forms/forms-applications/item id=e4cb1326-9782-6eee-9b55-ff00008c97d0

-EU Team-NB. Best practice Guidance for the submission of 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-regulation/

-EU Team-NB . IVDR technical Documentation training for manufacturers: Wednesday June 14th, 2023 https://www.teamnb.org/wp-content/uploads/members/M2023/Leaflet-IVD-TC-Manufacturers-Training-

-EMA pilots 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?fuseaction=notification.html&ntf;_id= 321463&version;_no=10

○ MDC for IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf;_id= 321397&version;_no=8

-Spain AEMPS: Notice addressed to Notified Bodies and Manufacturers of Nasal Sprays with Virucidal or Microbicidal action: https://www.aemps.gob.es/informa/la-aemps-publica-una-nota-de-aviso-dirigida-a-organismos-notificados-y-a-fabricantesde-esprais-nasales-con-accion-viricida-o-microbicida/

-Swiss - Q&A; 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-staff-assemblers-guide-diagnostic-xray-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 coformance with IEC Standards: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-x-ray-imaging-devices-conformance-iec-standards

-List of cleared Companion Diagnostic: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-orapproved-companion-diagnostic-devices-in-vitro-and-imaging-tools

-US Medsun February 2023: https://www.fda.gov/media/165125/download

-SAUDI-DI Webinar March 20th 2023 https://www.sfda.gov.sa/en/workshop/87814

-Link to Webex: https://zoom.us/j/95729656046?pwd=NmNOLzZYT0hmK3JqVXhPQ25LQmQ5Zz09 -Link to Webex: https://zoom.us/j/93572022832?pwd=K1ZVL2xTNXFHV3NEdXVGbk4yN0Z3Zz09

-South Africa. SAPHRA Q&A; on Licensing of Medical Device establishment: https://www.sahpra.org.za/wpcontent/uploads/2023/02/SAHPGL-MD-07_v3-Guideline-on-Questions-and-Answers-Licensing-of-Medical-Device- Establishments.pdf

○ Episode 219 - Biological Evaluation: Top Big 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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