Easy Medical Device Podcast

PMCF is something that was existing before with MDD 93/42/EC but this is more in focus now with the new EU MDR 2017/745. In this episode, I have invited Matthias Fink from TÜV SÜD to help us understand some of the mistakes we are making in the creation of our PMCF. He will tell us what to do and how to distinguish between the different PMCF types.

Who is Matthias Fink?

Board-certified orthopedic and trauma surgeon with 17 years of experience in orthopedic, trauma, and reconstructive surgery and extensive training in cardiovascular and thoracic surgery. Working for TÜV SÜD Product Service in Germany since 2016 as a Clinical Reviewer in the Clinical Centre of Excellence before joining TÜV SÜD America in 2017. Senior Clinical Expert Orthopedic Surgery for the Clinical Centre of Excellence and the Team Manager of the Clinical Focus Team North America. Presenter at national and international conferences and workshops on the clinical requirements and the implementation of the EU MDR.

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 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

• Matthias Fink LinkedIn Page: https://www.linkedin.com/in/matthias-fink-47a3b227/
• MDCG PMCF plan 2020-7: https://ec.europa.eu/health/document/download/a5cdb303-c782-4010-8723-7d389af678f7_en
• MDCG PMCF report 2020-8: https://ec.europa.eu/health/document/download/11121036-696a-4589-a311-c5525bd84df3_en
• TÜV SÜD Medical and Health Care LinkedIn Page: https://www.linkedin.com/showcase/tuvsud-medicaldevices/
• Application page for MDR services: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-regulation/mdr-request-for-service-registration
• Information on the clinical data requirements under the MDR: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/clinical-services/clinical-data-for-medical-devices
• A search engine of the TÜV SÜD resource center with webinars and published white papers: https://www.tuvsud.com/en-us/resource-centre

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

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

When you get audited, the configuration Front Room Back Room can help you a lot. But how to prepare for it? How to communicate between them? What are the rules to use this system?

I will tell you everything in this Podcast and if you need help don’t hesitate to contact me.

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 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 has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses…

Links 

• How to perform an Internal Audit: https://podcast.easymedicaldevice.com/80/
• How to prepare for a Medical Device Audit: https://easymedicaldevice.com/medical-device-audit/
• MDSAP audit: https://easymedicaldevice.com/mdsap/

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

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

HOT TOPIC

• Joint implementation and preparedness plan for Regulation 2017/746: https://lnkd.in/dasedpRA
• MDCG 2019-9 Rev 1 – SSCP update https://ec.europa.eu/health/document/download/5f082b2f-8d51-495c-9ab9-985a9f39ece4_en?filename=md_mdcg_2019_9_sscp_en.pdf
• EU Handover of Experts Panels to EMA: https://ec.europa.eu/health/latest-updates/handover-experts-panels-secretariat-2022-03-02_en
• SNITEM and BVMED ask for 2 additional years for the MDR transition period: https://www.bvmed.de/de/bvmed/presse/pressemeldungen/bvmed-und-snitem-starten-deutsch-franzoesische-initiative-zur-mdr-wir-muessen-jetzt-handeln
• Swissmedic: Database for registering Economic Operators and Medical Devices: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank.html
• AEMPS. Prior operating license for medical devices: https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2022-ps/nueva-instruccion-de-la-aemps-sobre-el-procedimiento-de-licencia-previa-de-funcionamiento-de-instalaciones-de-productos-sanitarios/
• US MEDSUN: https://www.fda.gov/media/156691/download
• China: Guidelines for registration and review of Artificial Intelligence Medical Devices: https://www.cmde.org.cn/CL0112/25219.html
• Egypt: Guideline for labeling data on medical supplies: https://edaegypt.gov.eg/media/q23cqi5w/minimum-label-req-english-version_nancy-fateen.pdf

Events

• Team PRRC Webinar April 12th, Sanctions if non-compliance to the regulation? https://www.linkedin.com/posts/team-prrc_mdr-ivdr-prrc-activity-6914642561617833985-5Moe
• Medtech Forum 3-5 May 2022: https://www.themedtechforum.eu/
• Green Belt Certification program
  • French April 18th until April 22nd: https://school.easymedicaldevice.com/course/gbfr3/
  • English April 25th, until April 29th: https://school.easymedicaldevice.com/course/gb18/

Notified Bodies

• SIQ Slovenia Institute of Quality and Metrology: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=316903&version_no=12

EMD

• Episode 170 – Why do we need the Common Specification for Class D IVDR [Andreas Stange] https://podcast.easymedicaldevice.com/170/
• Episode 171 – What lesson did we learn doing Clinical Evaluations? [Cesare Magri] https://podcast.easymedicaldevice.com/171/
• Episode 172 – How to sell Medical Devices online in the EU and US? [Michael Wetherington] https://podcast.easymedicaldevice.com/172/
• Episode 173 – What are the surprises during the MDR & IVDR transition [Erik Vollebregt] https://podcast.easymedicaldevice.com/173/

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

There was an announcement earlier about the transfer of the Expert Panel for EU MDR & IVDR to the European Medicine Agency. So Pharma will take care of this. Is there a possibility that we are moving to a model similar to the FDA?

Then another important piece of information came from SNITEM & BVMed. Both are asking for an extension of the EU MDR transition from May 2024 to May 2026. Why and would this be considered by the EU Commission?

Let’s ask our preferred lawyer Erik Vollebregt. And I am sure this will help you understand all concepts for EU MDR and IVDR

Who is Erik Vollebregt

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities, and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

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 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

• Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/
• Axon Lawyers: https://www.axonlawyers.com/
• Medical device legal blog: https://medicaldeviceslegal.com
• SNITEM & BVMed announcement: https://shop.mhp-verlag.de/en/news-release/bvmed-and-snitem-launch-german-french-initiative-on-mdr
• Expert Panel handover to EMA: https://ec.europa.eu/health/medical-devices-expert-panels/overview_en

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

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Since the implementation of EU MDR, there was a new phenomenon about Medical Device online sales. Online sales see their submissions to platforms like amazon rejected as they do have not all the documentation needed. This is also the same in the US market and it will become the same with EU IVDR when the date of implementation will start. So how do get in compliance? I have interviewed Michael Wetherington who will provide us with some hints on what should be done. If you need any support, don’t hesitate to contact me. I will then forward your request.

Who is Michael Wetherington?

Michael Wetherington is the Founder of MedicalRegs.com. MedicalRegs.com helps MedTech startups design devices with the applicable requirements in mind. They go further by providing regulatory services for the EU, US, Canada, and ASEAN markets. His background encompasses medical device R&D, accredited testing lab, and Notified Body experience. He is also a mentor at Elemed’s Mentoring Academy. And, when time permits, he likes to sing, play the drums, and the guitar.

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 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

• Michael Wetherington Linkedin: https://www.linkedin.com/in/medicalregsdotcom
• CE marking Blue guide: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52016XC0726(02)&from=BG
• MedicalRegs website: http://www.medicalregs.com/
• Easy Medical Device newsletter: https://easymedicaldevice.com/about-me/

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

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Since MDR is live we get from surprises to surprises. And we wanted in this episode to share with you some lessons learned regarding Clinical Evaluation. You maybe noticed that between MDD and MDR the audit style for CER is different. Even if the requirements are mostly the same. So today we'll try to guide you to be on the safe side with Cesare Magri from Be-on-Clinical.

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. Recently he founded be-on-Clinical together with Stefan Bolleininger in 2020.

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 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

• Cesare Magri Linkedin: https://www.linkedin.com/in/cesare-magri-92465345/
• Be-on-Quality: https://www.be-on-quality.com/en/about-en/
• Clinical Evaluation Template Pack: https://school.easymedicaldevice.com/product/clinical_pack/
• Podcast Episode - Create Intended Purpose: https://podcast.easymedicaldevice.com/65/

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

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

For IVDR products, there is more and more information that is coming.

So we make a small summary with Andreas Stange from TÜV SÜD and then we will discuss specifically the Draft Common Specification for certain Class D devices.

Andreas will explain to you why we need these common specifications and if this is mandatory. He will also explain the problem that comes now when the transition date for certain devices were extended.

Andreas will also invite you to join TÜV SÜD if you are interested to be part of this Notified Body as an auditor. Multiple places in the world are looking for you.

I hope this will be informative to you.

Who is Andreas Stange?

Dr. Andreas F. Stange is a vice president for the Medical and Health Services group at TÜV SÜD. Product Service. He serves as the global responsibility for the In-vitro Diagnostic Devices business line. Besides that, he is also overseeing TÜV SÜD`s Medical Health Services in North-East Asia.

Dr. Stange joined TÜV SÜD in 2001 as a medical device expert and had various positions since then in the group. Before taking the current position in March 2017, he served as President & CEO of TÜV SÜD in Japan for eight years.

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 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 has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

Links

• Andreas Stange Linkedin: https://www.linkedin.com/in/andreasstange
• Common Specification IVDR: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13304-In-vitro-diagnostic-medical-devices-common-specifications_en
• TÜV IVDR application: https://bit.ly/3HKGxw0
• IVDR episode: https://podcast.easymedicaldevice.com/26

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

HOT TOPICS

• IVDR
  • Common Specification certain Class D IVD – https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13304-In-vitro-diagnostic-medical-devices-common-specifications_en
  • Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) – https://ec.europa.eu/health/document/download/558ede8b-ff9a-4a8f-bb9d-d61e4a515b6a_en
• Spain – Registration of those responsible for placing medical devices on the market – https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2022-ps/la-aemps-pone-en-marcha-una-nueva-rps-para-el-registro-de-responsables-de-la-puesta-en-el-mercado-de-productos-sanitarios/
• UK to pilot world-leading approach to improve ethical adoption of AI in healthcare – https://www.gov.uk/government/news/uk-to-pilot-world-leading-approach-to-improve-ethical-adoption-of-ai-in-healthcare>
• Ireland – Certificate of Free Sale – https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/aut-g0026-guide-to-applications-for-certificates-of-free-sale-for-medical-devices-v10.pdf?sfvrsn=55

TRAINING

• MDR Training:https://school.easymedicaldevice.com/emd-course/

WORLDWIDE

• USA – How to report Medical Device Problems – https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files
  • QMS amendments https://www.federalregister.gov/public-inspection/2022-03227/medical-devices-quality-system-regulation and https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/proposed-rule-quality-system-regulation-amendments-frequently-asked-questions and https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices
• Saudi Arabia – Guidance on Innovation Medical Devices https://www.sfda.gov.sa/sites/default/files/2022-02/InnovativeMDSG002_0.pdf
  • Application form for issuance of Saudi Free Sale Certificate https://www.sfda.gov.sa/sites/default/files/2022-02/App-Form-Issuance-Saudi-Free-Sale-CertifA_0.docx
• China – Guidance for compilation of Technical Requirement for MD Products – https://www.cmde.org.cn/CL0112/25070.html

GUIDANCES

• MDCG 2022-4 – Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR – https://ec.europa.eu/health/document/download/e5714b2b-e98b-4fce-b5ff-d9141a8f30e1_en
• MDCG 2022-3 – Verification of manufactured class D IVDs by Notified Bodies – https://ec.europa.eu/health/document/download/ebbc4f6a-4945-4d5d-9c22-9bc1aafc5532_en
• Ireland – Medical Device Classification guidance – https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/adv-g0004-guide-to-classification-of-a-medical-device-v3.pdf?sfvrsn=15

NOSTALGIA

• Podcast Episode 166 – Why Design History File DHF is so important? With Alexandros Savvidis https://podcast.easymedicaldevice.com/166/
• Podcast Episode 167 – How to be great at Management Reviews https://podcast.easymedicaldevice.com/167/
• Podcast Episode 168 – Why would you need a Swiss Authorized Representative and Importer? https://podcast.easymedicaldevice.com/168/

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Since May 26th, 2021 Switzerland is now considered as non-EU country for Medical Devices. So to sell your products in Switzerland you need a Swiss Authorized Representative and a Swiss Importer. In this episode of the podcast, I will explain to you the reason for all that and the role and responsibility for the Manufacturer wanted to ship its products to Switzerland and the one of the Swiss Importers and Authorised Representative. If you have any questions, reach out to me: info at easymedicaldevice.com

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 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

• Swiss Meddo: https://www.fedlex.admin.ch/eli/cc/2020/552/en
• Swiss Economic Operators Guidance: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/pflichten-bevollmaechtigte.html
• Swiss CHRN Number: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/registriernummer-chrn.html

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

When we talk about Management Review, this is not really obvious how this should be done. In this video, I will try to explain to you what is expected to be seen by an auditor when they ask you to show them your Management Review. I will explain: – What is a Management Review – What you should consider when building your Management Review – Which documents are needed – What are the inputs and outputs with examples. I hope this will be helpful for you.

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 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…

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

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.