August 03, 2020

Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices

23 minutes

https://www.youtube.com/embed/6DaMJhtptZQ?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

In this monthly episode of the podcast, we talk about all that happened to the Medical Device industry. This is the July 2020 Update.

Within the Hot Topics, we will talk about the UK MHRA which warns about the “Certificate of Compliance” issued by certain certification bodies. We will also review the publication of the EU Commission regarding the PPE conformity assessment. And I will tell you the situation regarding the State of Play for the EU MDR.

Then we’ll review the Green Belt Certification Program. On the next topic, we will explain to you the situation of Notified Bodies. And some clarification on New Guidance and Standards. Don’t miss the clip regarding the Notified Bodies providing Pre-certification to their customers.

Finally, we’ll review what happened at Easy Medical Device these last weeks. Don’t forget to register for the Green Belt Certification Program.

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…

Links

HOT TOPICS

UK MHRA – Medical Device “Certificate of Compliance”/”Attestation of Conformity” https://www.gov.uk/government/news/medical-device-certificates-of-compliance-attestation-of-conformity-have-no-legal-standing-under-mdr

Conformity Assessment procedure for Protective Equipment: https://ec.europa.eu/docsroom/documents/42311/attachments/1/translations/en/renditions/native

State of play of EU MDR: https://ec.europa.eu/health/sites/health/files/md_newregulations/docs/implementationplan_en.pdf

Green Belt Certification Program: https://school.easymedicaldevice.com

NOTIFIED BODY

GMed : https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&body_type=NB&refe_cd=EPOS_43781

NANDO EU MDR 2017/745: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

NANDO EU IVDR 2017/746: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35

GUIDANCE AND STANDARD

ISO/TR 20416.2020 Medical Devices – Post-market surveillance for manufacturers: https://www.iso.org/standard/67942.html

MDCG 2020-13 – Clinical Evaluation Assessment Report Template: https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_clinical_evaluationtemplate_en.pdf

MDCG 2019-6 v2 Question and Answers: Requirements relating to Notified Bodies https://ec.europa.eu/docsroom/documents/37688

PODCAST

Episode 84 – How to become a PRRC with Team-PRRC https://podcast.easymedicaldevice.com/84/

Episode 85 – Understand IEC 62304 with Adnan Ashfaq https://podcast.easymedicaldevice.com/85/

Episode 86 – Learn UDI code with Sylvia Reingardt from GS1 https://podcast.easymedicaldevice.com/86/

LINKEDIN LIVE

What can we learn from 100 Days of audits with Stefan Bolleininger: https://www.youtube.com/watch?v=-5bG_E7ndrs&feature=youtu.be

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