Medical Device News – March 2022 Regulatory Update

HOT TOPICS

• IVDR
  • Common Specification certain Class D IVD – https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13304-In-vitro-diagnostic-medical-devices-common-specifications_en
  • Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) – https://ec.europa.eu/health/document/download/558ede8b-ff9a-4a8f-bb9d-d61e4a515b6a_en
  • EXPERT PANEL IVD:
    • https://ec.europa.eu/health/system/files/2022-02/pecp-ivd-2021-0000012-view_en.pdf

• Spain – Registration of those responsible for placing medical devices on the market – https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2022-ps/la-aemps-pone-en-marcha-una-nueva-rps-para-el-registro-de-responsables-de-la-puesta-en-el-mercado-de-productos-sanitarios/

• UK to pilot world-leading approach to improve ethical adoption of AI in healthcare – https://www.gov.uk/government/news/uk-to-pilot-world-leading-approach-to-improve-ethical-adoption-of-ai-in-healthcare>

• Ireland – Certificate of Free Sale – https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/aut-g0026-guide-to-applications-for-certificates-of-free-sale-for-medical-devices-v10.pdf?sfvrsn=55

TRAINING

• MDR Training: https://school.easymedicaldevice.com/emd-course/

WORLDWIDE

• USA – How to report Medical Device Problems – https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files
• QMS amendments https://www.federalregister.gov/public-inspection/2022-03227/medical-devices-quality-system-regulation and https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/proposed-rule-quality-system-regulation-amendments-frequently-asked-questions and https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices

• Saudi Arabia – Guidance on Innovation Medical Devices https://www.sfda.gov.sa/sites/default/files/2022-02/InnovativeMDSG002_0.pdf
• Application form for issuance of Saudi Free Sale Certificate https://www.sfda.gov.sa/sites/default/files/2022-02/App-Form-Issuance-Saudi-Free-Sale-CertifA_0.docx

• China – Guidance for compilation of Technical Requirement for MD Products – https://www.cmde.org.cn/CL0112/25070.html

GUIDANCES

• MDCG 2022-4 – Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR – https://ec.europa.eu/health/document/download/e5714b2b-e98b-4fce-b5ff-d9141a8f30e1_en

• MDCG 2022-3 – Verification of manufactured class D IVDs by Notified Bodies – https://ec.europa.eu/health/document/download/ebbc4f6a-4945-4d5d-9c22-9bc1aafc5532_en

• Ireland – Medical Device Classification guidance – https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/adv-g0004-guide-to-classification-of-a-medical-device-v3.pdf?sfvrsn=15

NOSTALGIA

• Podcast Episode 166 – Why Design History File DHF is so important? With Alexandros Savvidis https://podcast.easymedicaldevice.com/166/
• Podcast Episode 167 – How to be great at Management Reviews https://podcast.easymedicaldevice.com/167/
• Podcast Episode 168 – Why would you need a Swiss Authorized Representative and Importer? https://podcast.easymedicaldevice.com/168/