Medical Device News: September 2022 Regulatory Update

Here are the links to the Regulatory Updates

HOT TOPIC

• EUDAMED Timeline https://health.ec.europa.eu/system/files/2022-07/md_eudamed_timeline_en.pdf
• EU Call for application submission of EU Reference laboratories. https://health.ec.europa.eu/latest-updates/call-eu-reference-laboratories-sent-member-states-2022-08-05_en
  • HPRA & Spain – EU Commission call for Member states application of EU Reference labs for IVDs (EURLs) –  http://www.hpra.ie/homepage/medical-devices/news-events/item?t=/european-commission-publishes-call-for-european-union-reference-laboratories-for-ivds-designation&id=619f1226-9782-6eee-9b55-ff00008c97d0 
  • https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2022-ps/instrucciones-para-la-presentacion-de-solicitudes-de-designacion-de-laboratorios-de-referencia-de-la-ue-para-productos-sanitarios-de-diagnostico-in-vitro/  
  • Belgium FAMHP: https://www.famhp.be/en/news/call_for_belgian_laboratories_to_apply_to_become_the_european_union_reference_laboratory_for –
• Clinical Evaluation Consultation Procedure
  • CECP Class III implantable tricuspide valve procedure https://health.ec.europa.eu/latest-updates/expert-decision-and-opinion-context-clinical-evaluation-consultation-procedure-cecp-2022-08-24_en
  • CECP 2022-000213 Transcatheter heath valve   https://health.ec.europa.eu/document/download/3ed8dacb-2b9d-4096-bc84-0b408f8492c4_en?filename=cecp-2022-000213_opinion_en.pdf
• Draft Reclassification of Annex XVI products https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12972-Medical-devices-reclassification-of-products-without-an-intended-medical-purpose_en
• ROW
  • SFDA introduction to regulation Workshop – REMOTELY: https://www.sfda.gov.sa/en/workshop/87146
  • SAHPRA Guidances on clinical trial
  • https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-07_v4-Guideline-for-Post-Clinical-Trial-Access.pdf
  • https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-06_v2-Guideline-for-The-Procedure-of-Consultation-Meetings-with-Clinical-Trial-Applicants.pdf
  • https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-04-Oversight-and-Monitoring-in-Clinical-Trials_August-2022_V4.pdf
  • https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-03-Emergency_Procedures_Clinical_Trial_Sites_August-2022_v3.pdf

• China – Guidance for registration of percutaneous Enteral Nutrition Catheter and Disposable Human Arterial Blood Samplers https://www.cmde.org.cn/flfg/zdyz/zqyjg/zqyjgwy/20220826111515137.html
• India: List of certified Medical Device Testing Laboratories under MDR 2017 https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODg4Mg==
• Australia TGA – Regulatory Guidelines for Medical Devices https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-medical-devices-argmd

TRAINING

• Green Belt Session 20: https://school.easymedicaldevice.com/product/gb/
• Scube Technologies: https://scube-technologies.com/

NOTIFIED BODIES

• 32nd NB MDR – Bureau Veritas Italia https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=318721&version_no=15

GUIDANCES

• MDCG 2022-13 – Designation, re-assessment and notification of conformity assessment bodies and notified bodies https://health.ec.europa.eu/document/download/27f91dc2-b5bc-44f9-a975-5024ce3ea556_en?filename=mdcg_2022-13_en.pdf
• MDCG 2022-14 Transition to the MDR and IVDR: https://health.ec.europa.eu/system/files/2022-08/mdcg_2022-14_en.pdf

EASY MEDICAL DEVICE PODCAST

• Medtech Europe Forum Interview https://podcast.easymedicaldevice.com/188/
• AI Act Erik Vollebregt https://podcast.easymedicaldevice.com/189/
• Cleanroom Philippe Bourbon Icare https://podcast.easymedicaldevice.com/190/
• How to create a Technical File https://podcast.easymedicaldevice.com/191/
• When you think 510k but FDA says DeNovo with Spencer Jones Lineus Medical https://podcast.easymedicaldevice.com/192/
• Discontinuation process with Alexandros Savvidis https://podcast.easymedicaldevice.com/193/
• New Blue Guide Erik Vollebregt https://podcast.easymedicaldevice.com/194/
• SaMD and SiMD Design Dossier Anindya Mookerjea https://podcast.easymedicaldevice.com/195/