Medical Device News: March 2023 Regulatory Update

A lot of information within this update. So check the show notes as this may be a bit too much for you. This March Update is going through Europe but also US, Middle East, South Africa. A world tour. lol

The post Medical Device News: March 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Here is your Regulatory Update for the month of March 2023.

Check all the links on Medboard Platform: https://www.medboard.com/reports/easy-medical-device-regulatory-update/2023/march/

– 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

► Social Media to follow

■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

■ Twitter: https://twitter.com/elazzouzim

■ Pinterest: https://www.pinterest.com/easymedicaldevice

■ Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News: March 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir