Medical Device News - March 2020 Regulatory Review (EU MDR)

► Webpage: https://podcast.easymedicaldevice.com/70/

March 2020 is really a period with a lot of information to provide for the Medical Device Industry.
We will discuss:
- Medical Device Situation during the pandemic
- Notified Body analytics
- Medical Device guidance released
- Podcast episodes
- LinkedIn Live
- PRRC agreement

Don't miss the links with all the source of information
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► 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 company 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, Podcast, Online courses...

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► Links from the Video

■ Coronavirus
○ DoA delay 1 year: https://audiovisual.ec.europa.eu/en/video/I-187348
○ Proposal for extension of MDR DoA to + 1 year: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1585914772359&uri=COM:2020:144:FIN
○ Erik Vollebregt Blog Post: https://medicaldeviceslegal.com/2020/04/04/the-mdr-amendment-proposal-more-than-meets-the-eye/
○ Notified Body audits suspended: https://www.dakks.de/en/content/dakks-adopts-safety-measures-suspension-site-assessments
○ Coronavirus impact on the Medical Device Industry: Medical Device Industry impact due to Coronavirus Outbreak (EU MDR): https://youtu.be/_m3egM0HEns
○ MHRA guidance: https://www.gov.uk/guidance/mhra-regulatory-flexibilities-resulting-from-coronavirus-covid-19
○ Free Standards available for Covid19 products: https://www.cencenelec.eu/News/Press_Releases/Pages/PR-2020-003.aspx

■ Notified Body accredited
○ State of play March 2020: https://ec.europa.eu/docsroom/documents/40341?locale=en
○ MDR 2017/745 NB: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
○ IVDR 2017/746 NB: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35

■ Regulatory Updates
○ Harmonized Standard update for MDD 2020/437: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1585235207379&uri=CELEX:32020D0437
○ Harmonized Standard update for AIMDD 2020/438: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1585235819491&uri=CELEX:32020D0438
○ Harmonized Standard update for IVDD 2020/439: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1585235896183&uri=CELEX:32020D0439
○ MDCG Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software 2020-1: https://ec.europa.eu/docsroom/documents/40323?locale=en
○ MDCG Guidance Class Transitional Provision under Article 120(3 and 4) 2020-2: https://ec.europa.eu/docsroom/documents/40324?locale=en
○ MDCG Guidance Significant Change 2020-3: https://ec.europa.eu/docsroom/documents/40301/attachments/1/translations/en/renditions/native

■ Easy Medical Device podcasts
○ Episode 67 - Cybersecurity with Erik Vollebregt: https://podcast.easymedicaldevice.com/67/
○ Episode 68 - Class Is, Im and Ir with Elem Ayne: https://podcast.easymedicaldevice.com/68/
○ Episode 69 - Significant Changes with Erik Vollebregt: https://podcast.easymedicaldevice.com/69/

■ LinkedIn Live
○ How to classify a Medical Device: How to classify a Medical Device? (EU MDR Case Studies): https://youtu.be/JXuLft-IEZg
○ FAQ on Economic Operators with Erik Vollebregt: FAQ Medical Device Economic Operators? (EU MDR and IVDR): https://youtu.be/qvOyEofrhgk
○ Coronavirus outbreak with Erik Vollebregt, Bassil Akra, and Gert Bos: Medical Device Industry impact due to Coronavirus Outbreak (EU MDR): https://youtu.be/_m3egM0HEns

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► 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

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#medtech #medicaldevice #compliance

Видео Medical Device News - March 2020 Regulatory Review (EU MDR) канала Easy Medical Device