Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices
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…
- 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
- 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
- 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/
- What can we learn from 100 Days of audits with Stefan Bolleininger: https://www.youtube.com/watch?v=-5bG_E7ndrs&feature=youtu.be