Medical Device News – May 2021 Update [EU MDR 2017/745]

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, Online courses…

Links

■ HOT

• Updated Implementing Plan: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_rolling-plan_en.pdf
• Expert Panel: https://ec.europa.eu/health/md_expertpanels/overview_en
• Factsheet for manufacturers of Implantable Medical Devices https://ec.europa.eu/health/sites/health/files/md_topics-interest/docs/md_implany-cards_factsheet_en.pdf
• MDCG 2019-8 v2. Guidance Implant Card https://ec.europa.eu/docsroom/documents/40321/attachments/1/translations/en/renditions/native
• Factsheet for class I medical devices: https://ec.europa.eu/health/sites/health/files/md_topics-interest/docs/md_mdcg_2021_factsheet-cl1_en.pdf
• MHRA Certificate of Free Sale Reference Guide: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/978388/Certificates_of_Free_Sale_Reference_Guide_April_2021_Final_v1.pdf

■ Standardisation

• IVDD Harmonized Standard: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021D0609
• MDD Harmonized Standard: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021D0610
• AIMDD Harmonized Standard: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021D0611
• Standardisation page: https://ec.europa.eu/growth/tools-databases/mandates/index.cfm?fuseaction=search.detail&id=599#

■ Notified Bodies

• Team Notified Body Survey: https://www.team-nb.org/wp-content/uploads/2021/04/Team-NB-MD-Sector-Survey-PressRelease-20210414.pdf
• NB Eurofins expert service Oy (Finland): https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=311931&version_no=5

■ Guidance and Standards

• MDCG 2018-1 Guidance on UDI-DI and Basic UDI-DI https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2018-1_guidance_udi-di_en.pdf
• MDCG 2021-6 Q&A regarding clinical investigation: https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_2021-6_en.pdf
• MDCG 2021-4 Application of transitional provisions for certification of Class D in vitro Diagnostic medical devices according to EU MDR 2017/745 https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_2021-4_en.pdf
• ISO/TS 37137:2021 Biological Evaluation of Absorbable medical devices https://www.iso.org/standard/73582.html

■ Podcast/Live

• Episode 123: How to write a Performance Evaluation with Hakan Inan: https://podcast.easymedicaldevice.com/123/
• Episode 124: How to perform correctly a Merger & Acquisition during the MDR transition with Erik Vollebregt? https://podcast.easymedicaldevice.com/124/
• Episode 125: Checklist – What is important before the EU MDR DoA? https://podcast.easymedicaldevice.com/125/
• LinkedIn Live – All about PMCF with Cesare Magri: All about PMCF with Cesare Magri [EU MDR 2017/745]

■ TELEGRAM GROUP: https://t.me/easymedicaldevice