Medical Device News -June 2023 regulatory update

Sponsor MedBoard: www.medboard.com 

EUROPE 

• Notified Body overview: https://health.ec.europa.eu/system/files/2023-05/notifiedbodies_overview_en.pdf 

• EU MDR and IVDR consolidated versions 
  • EU MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20230320
  • EU IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20230320 

• Confirmation letter: EU Commission: https://health.ec.europa.eu/latest-updates/template-nb-confirmation-letter-framework-regulation-eu-2023607-2023-05-24_en 

• MDCG 2020-3 Significant changes: https://health.ec.europa.eu/latest-updates/update-mdcg-2020-3-rev1-guidance-significant-changes-regarding-transitional-provision-under-article-2023-05-12_en 
• Update Annex XVI timeline: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=PI_COM:Ares(2023)3232054 

• EMDN maintenance project launched: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6262 
• Spain: AEMPS and CNCps recognize the need to demonstrate to third parties the validity of expired certificates: https://www.aemps.gob.es/informa/la-aemps-informa-sobre-el-nuevo-procedimiento-del-cncps-para-confirmar-la-validez-de-los-certificados-emitidos-conforme-a-mdd/ 
• Finland: RoHS is also applicable to Medical Devices: https://www.fimea.fi/web/en/-/rohs-act-also-concerns-medical-devices 

Training: 

• Green Belt Certification Program June 26th until June 30th. https://school.easymedicaldevice.com/course/gb26 

Switzerland 

• Incident report for economic operators: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_20_009d_wl_mdv_vorkommnis_hersteller_mepv.pdf.download.pdf/MU680_20_009e_WL%20Incident%20economic%20operators.pdf 
• Incident report for users: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_20_008d_wl-vorkommnismeldung-anwender.pdf.download.pdf/MU680_20_008e_WL%20incident%20report%20user.pdf 
• Designation of a Vigilance contact person for hospitals: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_10_007d_wl-vigilance-kontaktperson-medizinprodukte.pdf.download.pdf/MU680_10_007e_WL%20Vigilance%20contact%20person%20for%20medical%20devices.pdf 

United Kingdom 

• New tutorial videos MHRA “How to register medical devices”: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market 
• New Regulatory Pathway IDAP: https://www.gov.uk/government/news/new-regulatory-pathway-set-to-support-safe-patient-access-to-innovative-medical-technologies 
• Assistive Technology: https://www.gov.uk/government/publications/assistive-technology-definition-and-safe-use/assistive-technology-definition-and-safe-use 
• Report Adverse incidents for Software: https://www.gov.uk/government/publications/reporting-adverse-incidents-involving-software-as-a-medical-device-under-the-vigilance-system/guidance-for-manufacturers-on-reporting-adverse-incidents-involving-software-as-a-medical-device-under-the-vigilance-system   

ROW 

• Australia: Guidance on applying the Advertising Code rules: https://www.tga.gov.au/how-we-regulate/advertising/how-advertise/advertising-guidance/resources/resource/guidance/guidance-applying-advertising-code-rules 
• Canada: Consultation on proposed amendments to the Medical Devices Regulations and Food and Drug Regulations:  https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/consultation-proposed-amendments-medical-devices-food-drug-regulations.html 
• India: CDSCO updated list of Laboratories for conducting Performance Evaluation of In – Vitro Diagnostic Medical Device  :  https://cdsco.gov.in/opencms/opencms/en/Notifications/Public-Notices/ 

• Egypt: European Parliament Decision of March 2023 regarding the transitional grace periods granted in relation to the application of MDR&IVDR rules and procedures: https://www.edaegypt.gov.eg/ar/%D8%A7%D9%84%D9%85%D8%B1%D9%83%D8%B2-%D8%A7%D9%84%D8%A7%D8%B9%D9%84%D8%A7%D9%85%D9%89/%D8%A7%D9%84%D8%A5%D8%B9%D9%84%D8%A7%D9%86%D8%A7%D8%AA/%D9%82%D8%B1%D8%A7%D8%B1-%D8%A7%D9%84%D8%A8%D8%B1%D9%84%D9%85%D8%A7%D9%86-%D8%A7%D9%84%D8%A3%D9%88%D8%B1%D9%88%D8%A8%D9%8A-%D8%A7%D9%84%D8%B5%D8%A7%D8%AF%D8%B1-%D9%81%D9%89-%D9%85%D8%A7%D8%B1%D8%B3-2023-%D8%A7%D9%84%D8%AE%D8%A7%D8%B5-%D8%A8%D8%A7%D9%84%D9%85%D9%87%D9%84-%D8%A7%D9%84%D8%A5%D9%86%D8%AA%D9%82%D8%A7%D9%84%D9%8A%D8%A9-%D8%A7%D9%84%D9%85%D9%85%D9%86%D9%88%D8%AD%D8%A9-%D8%A8%D8%AE%D8%B5%D9%88%D8%B5-%D8%AA%D8%B7%D8%A8%D9%8A%D9%82-%D9%82%D9%88%D8%A7%D8%B9%D8%AF-%D9%88%D8%A5%D8%AC%D8%B1%D8%A7%D8%A1%D8%A7%D8%AA-mdr-ivdr/ 
• Saudi Arabia Webinar:
  • Explain The Essential Principles of Safety and Performance for Medical Devices:  https://www.sfda.gov.sa/en/workshop/88451 
  • Risk Management for Medical Devices: ISO 14971 Requirements https://www.sfda.gov.sa/en/workshop/88450 

Podcast

• Podcast 231: The truth about the UK vs EU situation with Claire Dyson: https://podcast.easymedicaldevice.com/231-2/ 
• Podcast 232: Technical File inconsistencies identified by Notified Bodies with Adam Rae: https://podcast.easymedicaldevice.com/232-2/ 
• Podcast 233: What if your Medical Device company goes bankrupt with Karandeep Badwal: https://podcast.easymedicaldevice.com/233-2/ 
• Podcast 234: How to master Regulatory Intelligence with Ivan Perez Chamorro: https://podcast.easymedicaldevice.com/234-2/ 

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Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

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