Medical Device made Easy Podcast – Détails, épisodes et analyse

In this episode, Stefan Bolleininger will explain you can save money on your MDR or IVDR submission just by choosing the right MDR or IVDR code and by following some of his advice. 

Who is Stefan Bolleininger? 

 Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe. He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections. In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”.

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link

Stefan Bolleininger Linkedin: https://www.linkedin.com/in/stefan-bolleininger-3a717028/ 

BeOnQuality Website: https://www.be-on-quality.com/ 

MDCG 2019-14 – MDR code: https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_14_mdr_codes_en_0.pdf 

MDCG 2021-14 – IVDR code: https://health.ec.europa.eu/system/files/2021-07/md_mdcg_2021-14-guidance-ivdr-codes_en_0.pdf 

EMDN Code: https://webgate.ec.europa.eu/dyna2/emdn/ 

Notified Body database NANDO : https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/by-legislation 

eQMS for Medical Devices: https://eqms-smarteye.com/ 

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

Medboard

https://www.medboard.com/

EU

Urgent update needed - EU MDR and IVDR: https://www.europarl.europa.eu/doceo/document/TA-10-2024-0028_EN.pdf

HMA communication: https://www.hma.eu/fileadmin/dateien/Medical_Devices/CGMD/241018_Letter.pdf

EU Commission Newsletter - What are the hot news: https://ec.europa.eu/newsroom/sante/newsletter-archives/56793

MDCG 2021-25 ;legacy devices & devices placed on the market prior to 26 May 2021: https://health.ec.europa.eu/document/download/cbb11a6e-f0f3-4e30-af5e-990f9ef68bc1_en?filename=md_mdcg_2021_25_en.pdf

Blog post article: https://easymedicaldevice.com/legacy-devices-clarification-with-mdcg-2021-25/

Notified Bodies Overview - How many still remaining: https://health.ec.europa.eu/do cument/download/3d407427-fad0-498a-b1ef-2db28c9f4423_en?filename=notifiedbodies_overview_en.pdf

New MDR NEOEMKI  in Bulgaria: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=0e4e49a1afef458542254b3556a5e83d85321b23&group=NOTIFICATION&download=true

HPRA Notification for In-house Manufacturers - Frequently Asked Questions: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/sur-g0053-faq-on-notification-for-in-house-manufacturers-of-medical-devices-and-in-vitro-diagnostic-medical-devices-v1.pdf?sfvrsn=8

Harmonized Standards Summary List - For MDR and IVDR:

MDR: https://ec.europa.eu/docsroom/documents/62156/attachments/1/translations/en/renditions/native

IVDR: https://ec.europa.eu/docsroom/documents/62158/attachments/1/translations/en/renditions/native

MDCG 2024-11 - Qualification of IVDR: https://health.ec.europa.eu/document/download/12b92152-371f-404d-a865-93800cd5cdca_en?filename=mdcg_2024-11_en.pdf

PMS is not implemented correctly - IGJ report is shocking: https://english.igj.nl/binaries/igj-en/documenten/publication/2024/10/08/call-to-medical-device-manufacturers-implement-an-effective-pms-system/20241003_Call+to+medical+device+manufacturers+implement+effective+PMS+system.pdf

Blog post: https://easymedicaldevice.com/how-can-i-do-my-post-market-surveillance/

EUDAMED in Turkey - Message: You should use it: https://titck.gov.tr/duyuru/tcokka-tibbi-cihazlara-iliskin-avrupa-veri-tabani-hakkinda-teblig-taslagina-iliskin-duyuru-11102024094328

Turkey registration limited - 10 per individual: https://titck.gov.tr/duyuru/tibbi-cihaz-belge-ve-urun-kaydi-yapan-firma-ve-kullanicilarina-iliskin-duyuru-07102024151251

UK Post-Market Surveillance - New amendment: https://www.legislation.gov.uk/ukdsi/2024/9780348264593/data.pdf

Training

Team-NB training on Technical Documentation-  November 6th: https://www.team-nb.org/wp-content/uploads/2024/07/Leaflet-MDR-TD-Manufacturers-Training-20241106.pdf

Events

MedtechConf events - Check the MAP

Afrisummit 2024 in Cairo November 3 to 6: https://medtechconf.com/event/afrisummit/

MEDxD 2024 In Berlin November 7th: https://medtechconf.com/event/medxd-medtech-meets-digital-2024/

Medica 2024 in Dusseldorf November 11th: https://medtechconf.com/event/medica-2024/

ROW

Australia

 What is a Personalized Medical Device? - In Australia: https://www.tga.gov.au/sites/default/files/2024-10/understanding-personalised-medical-devices%20rules-including-3d-printed%20devices.pdf

How to submit a notification on custom-made device in Australia: https://www.tga.gov.au/sites/default/files/2023-12/How-submit-custom-made-medical-device-patient-matched-medical-device-notification-guide.pdf

Mexico

GMP for Mexico - Draft document: https://www.dof.gob.mx/nota_detalle.php?codigo=5734591&fecha=26/07/2024#gsc.tab=0

South Africa

South Africa and Australia MoU - Harmonization is on the way: https://www.sahpra.org.za/news-and-updates/south-african-and-australian-health-product-regulators-to-share-regulatory-information-and-expertise/

PODCAST

Podcast Nostalgia  - Let's review

Episode 306 - What are the TOP 3 issues on CAPA with Georg Digel: https://podcast.easymedicaldevice.com/306-2/

Episode 307 - What does a strategy for Regulatory Compliance Look like? https://podcast.easymedicaldevice.com/307-2/

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

In this episode, Stephen O’Rourke that was not working within the Medical Device industry will share with us is journey from Zero knowledge in the field to running projects. Listen to his journey in case you are also willing to breakthrough the medical device field. 

Who is Stephen O’Rourke? 

Stephen O'Rourke, based in Berlin, Germany, is a seasoned regulatory affairs expert with extensive experience across the food, biotech, and medical device industries. With deep expertise in EU and global regulations, he is dedicated to helping companies navigate complex regulatory landscapes, ensuring the successful launch of innovative products. His journey and transition into medical device regulation began at one of Europe’s largest clinics, where he was instrumental in kickstarting their MDR consultancy. Outside of his regulatory work, Stephen is an advocate for transparency and accountability in politics, having run for the European Parliament in 2024 to champion these causes. He is also actively involved in promoting Ireland’s traditional sports and enjoys exploring Berlin with his family. 

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link

Stephen O’Rourke LinkedIn: https://www.linkedin.com/in/sorourkede/ 

AI Act Summit Link: https://medtechconf.com/event/ai-act-summit/ 

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

Imagine that you have a question to ask the EU Commission, your Notified Body, or any association about being a PRRC. Then this is the episode to listen to. During the Team-PRRC event on November 3 and 4 2022, I was able to record some of the sessions and propose them to you know. Here are the people that were on the panel:

• Bassil Akra, Board Member of Team-PRRC association as the facilitator https://www.linkedin.com/in/bassil-akra-2388b84b/
• Mario Gabrielli Cossellu – EU Commission https://www.linkedin.com/in/mariogabriellicossellu/
• Orla Daly – EU Commission https://www.linkedin.com/in/orla-daly-354128b4/
• Francoise Schlemmer Team-NB https://www.linkedin.com/in/francoise-schlemmer-baa16011/
• Christopher Kipp BVMed https://www.linkedin.com/in/christopher-kipp-b16ba71b1/

And here are the questions answered:

• Why a PRRC is needed
• Will Notified Bodies issue an NC when manufacturers have no PRRC when they are following the MDD directive?
• What does it mean to ensure compliance for a PRRC?
• What notified bodies are expecting from PRRC to ensure compliance
• Is it the intention of the regulation to put PRRC in Jail?
• Can a CEO be a PRRC for its company?
• Lake of resources to help manufacturers?
• PRRC Training?

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Link

• Team-PRRC association: https://www.team-prrc.eu/
• EU Authorized Representative: https://easymedicaldevice.com/eu-rep/
• UK responsible person: https://easymedicaldevice.com/uk-responsible-person/
• Swiss representative: https://easymedicaldevice.com/swiss-authorised-representative/

HOT TOPICS

Europe

• Common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
  • https://webgate.ec.europa.eu/regdel/#/implementingActs/7377?lang=en
  • https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R2346
• Reclassification of groups of certain active products without an intended medical purpose
  • https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32022R2347
• Updated information pack for candidate EU reference laboratories published
  • https://health.ec.europa.eu/latest-updates/updated-information-pack-candidate-eu-reference-laboratories-published-2022-11-30_en
• 51th CAMD Meeting Statement (The European Competent Authorities for Medical Devices (CAMD))
  • https://www.camd-europe.eu/other/51th-camd-meeting-statement/
• MDCG 2022-16: Guidance on Authorised Representatives Regulation
  • https://health.ec.europa.eu/system/files/2022-10/mdcg_202216_en.pdf
• New Notified Body EU MDR: INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s (Czech Republic)
  • https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=320100&version_no=24

• Training
  • December 12th until December 16th https://school.easymedicaldevice.com/product/gb

• UK MHRA: Borderline products: how to tell if your product is a medical device: New section added 'Risk classification of medical devices’
  • https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medical-device#risk-classification-of-medical-devices
• Swissmedic: Plan to accept FDA products in Switzerland
  • https://www.swiss-medtech.ch/en/news/politicians-decide-favour-patient-care
  • https://par-pcache.simplex.tv/subject/?themeColor=AA9E72&subjectID=58905&language=de
• Finland: Power blackouts do not require special preparedness measures from the users of medicines and medical devices
  • https://www.fimea.fi/web/en/-/power-blackouts-do-not-require-special-preparedness-measures-from-the-users-of-medicines-and-medical-devices

Rest of the world

• United States: EUA Template for Developers of Antigen Diagnostic Tests (MonkeyPox)
  • https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/monkeypox-emergency-use-authorizations-medical-devices#templates
• United States: MedSun Newsletter - November 2022
  • https://www.fda.gov/media/162771/download
• Canada: List of recognized standards for medical devices:
  • https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/standards/list-recognized-standards-medical-devices-guidance/list-recognized-standards-medical-devices-guidance.pdf
• Canada: November 8, 2022 updates to list of medical devices for mandatory shortage and discontinuation reporting
  • https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/11-08-changes-reporting-medical-device-shortage.html
• Barhain: Reminder Regarding Deadline for Medical Devices and Supplies Authorized Representatives Registration
  • https://www.nhra.bh/Media/Announcement/MediaHandler/ImageHandler/documents/Announcements/Announcement2022_Circular No. (35) 2022_To Medical Devices Importers and Suppliers_Deadline for Medical Devices Supplies Authorized Reps Registration_20221124.pdf

If you look for an Authorized Representative or Importer in the European area, contact us at EO@easymedicaldevice.com

PODCASTS

• Episode 205: Your Software/IVD clinical report is completely WRONG! https://podcast.easymedicaldevice.com/205/
• Episode 206: Regulatory Pathway: How to reach the US market? [510k exempt] https://podcast.easymedicaldevice.com/206-2/
• Episode 207: Why Risk Management is important to Medical Device development? https://podcast.easymedicaldevice.com/207-2/
• Episode 208: How to choose the best Sterilization Method for Medical Devices? https://podcast.easymedicaldevice.com/208-2/

Sterilization for medical devices is a critical topic. Now when you are developing your Medical Device, you should start by asking which sterilization process you should follow for your devices because this will lead to the question of which material you should use to build your device… So to help us have a clear understanding of how Sterilization should be defined for your medical devices, I have invited Jane Scally from Trinzo.

Who is Jane Scally?

Jane has supported medical device manufacturers around the world in the areas of quality management systems, remediation, strategic growth and planning, M&A due diligence and integration management, MDR transition, biocompatibility, and sterilization. Jane has Notified Body experience, performing QMS site audits in tandem with technical documentation reviews. These activities supported manufacturers maintaining their certification under the Directives and those transitioning to MDR 2017/745. Jane holds a Bachelor of Science in Applied Biology and Biopharmaceutical Science, a Higher Diploma in Pharmaceutical Business, and a Master of Science in Medical Technology Regulatory Affairs.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links

• Jane Scally LinkedIn Profile: https://www.linkedin.com/in/jane-scally-b07206a5/
• Trinzo Website: https://www.trinzo.com/
• EU UK Swiss Authorized Representative and Importer: https://easymedicaldevice.com/authorised-representative-and-importer/
• eQMS Scube SmartEye: https://scube-technologies.com/

Risk Management is a discipline of its own within the Medical Device field. In ISO 13485, EU MDR 2017/745, IVDR 2017/746, FDA QSR, MDSAP… All of them talk about Risk Management. You should manage your risks. But why is this so important or even critical? This is what we will discuss with Kailash Kalidoss who is a Medical Device Engineer and also a NASA Ambassador. He will share with us his experience.

PS: if your company needs an EU, UK or Swiss Authorized representative or Importer, don’t hesitate to contact Easy Medical Device. See the link below.

Who is Kailash Kalidoss?

The foundation of my professional experience is in consulting for complex MedTech projects, from conceptualization to product release. In my 13+ years of experience, I have worked as a Design control consultant for various leading US-based Medical Device Companies. I’m also certified by AAMI for Medical Quality System Regulations. Currently, I work for a cutting-edge engineering consulting firm based out of the Bay area in California. Academically my career is well rounded with an MBA from a prestigious B-School. Also, I have good exposure to STEM fields through MS and Engineering Bachelor degrees earlier, to effectively complement the B-School erudition. SPECIALITIES: Medical Device Design Control, Verification, and Validation, Software in Medical Devices and SaMD, Quality, Medical Device Regulations BEYOND WORK: Aerospace Educator for Civil Air Patrol, a United States Airforce Auxiliary. NASA Solar System Ambassador.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links

• Kailash Kalidoss LinkedIn: https://www.linkedin.com/in/kailashkalidoss
• iso 14971:2019. https://www.iso.org/standard/72704.html
• EU MDR 2017/745: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1589797311848&uri=CELEX:02017R0745-20200424
• Authorized Representative and Importer for EU, UK, and Switzerland: https://easymedicaldevice.com/authorised-representative-and-importer/
• eQMS SmartEye: https://scube-technologies.com/why-s-cube/

You maybe ask yourself how to get to distribute your Medical Device in the US? Then listen to the story of MysteryVibe with their devices. He will answer questions such as: - Why the US market and not the EU? - What was the interaction with consultants for the Quality and Regulatory aspects? - How is it to work with a Quality Management System? - How is the logistic of the product working? - Why perform Clinical Investigations? So I hope this will help you understand the market by listening to the MysteryVibe Journey.

Who is Dr.Soumyadip Rakshit?

Dr. Soum Rakshit is the Co-Founder & CEO of award-winning sexual health company, MysteryVibe. Their mission is to make sexual health accessible to all – across all ages, genders & orientations. In his role as CEO of MysteryVibe, he focuses on pushing the boundaries on R&D, customer experience and supporting their long-term goal of making sexual health an integral part of our overall health. Soumyadip passionately believes that by empowering people with actionable knowledge & purposeful innovation is the way to make this happen. Soumyadip built and sold his first startup in defence electronics by age 26, and has won 20+ International design awards for his product designs.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links from the Video

• Dr. Soumyadip Rakshit Linkedin: https://www.linkedin.com/in/soum
• Mysteryvibe website: https://mysteryvibe.com/
• Literature on disease targeted: https://eventclass.org/contxt_essm2022/scientific/online-program/session?s=P-07#e524
• MysteryVibe LinkedIn Page: https://www.linkedin.com/company/mysteryvibe/
• Easy Medical Device Authorized Representative: https://easymedicaldevice.com/authorised-representative-and-importer/

In this episode, Cesare Magri from 4BetterDevices will explain to us why medical device manufacturers are making mistakes when they try to gather Clinical Evidence for their Software or IVD devices. You may have made also this mistake and it would be better to know that before your Notified Body rejects your application. You will understand how to solve that and get some advice from Cesare.

Who is Cesare Magri?

Cesare has a mixed Background: Physics and Neuroscience, PhD in Informatics. He worked as a biostatistician at Max Planck in Tübingen and started working with medical devices and clinical evaluations in 2013. He founded be-on-Clinical together with Stefan Bolleininger in 2020. And recently, created the CRO 4BetterDevices.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links from the Video

• Cesare Magri LinkedIn: https://www.linkedin.com/in/cesare-magri-92465345/
• Be-on-Clinical LinkedIn Company: https://www.linkedin.com/company/be-on-clinical/about/

This month we will have some updates on:

• Annex XVI
• ACRAS Event
• MDCG Agenda
• Commission Contact update
• Team-NB position paper on Off-label use
• Team-NB position paper on Cybersecurity
• New Notified Body for EU MDR
• Notified Body survey
• MHRA 12-month extension
• MHRA’s new Vigilance system
• Swiss Medtech proposal
• Team-PRRC annual meeting
• USA Medsun
• Malaysia training on Good Distribution Practices
• China Medical Device Recall
• EU MDR training
• EUDAMED training
• PRRC Training
• Book to buy
• Podcast episodes of the month.

Enjoy!

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links

• Links to the episode: https://www.medboard.com/reports/easymedicaldevice/regulatory-update/