Easy Medical Device Podcast

DHF or Design History File or DMR or DHR or … What does all this mean? We will focus on DHF but we’ll also provide an explanation of the other acronyms.

In this episode of the Podcast, Alexandros Savvidis will share with us his experience. He’ll provide some examples. So don’t hesitate to check this episode if you are willing to get more understanding and ask your questions in the comments.

Who is Alexandros Savvidis?

Alexandros Savvidis is a Senior Medical Device Specialist active more than 17 years in multiple areas including Regulatory Affairs, Quality Management, R&D, Sales, Technical Support & Analysis.

After his studies in Biomedical Engineering, he has worked in the medical devices as also the pharma packaging industry across Europe in Germany, Switzerland, Netherlands, UK, and Greece. He has organized and contributed as an RA Specialist to various successful international certifications of medical devices of all classes.

Alexandros has gained one overall experience and deep understanding through his various roles on the full norm compliant development and certification process, like many other aspects like GMP, quality, risk management, vigilance, or clinical evaluations.

He has worked on small, middle-size companies alone or a team member, or even on cross-functional teams of Life Science Giants. In the last years is his main focus is the implementation of MDR requirements and updates

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

• Alexandros Linkedin Profile: https://www.linkedin.com/in/alexandrossavvidis/
• What is a DHF?: https://www.greenlight.guru/glossary/design-history-file

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The February 2022 Regulatory Update contains a lot of information that may help you to maintain your team up-to-date with the new requirements.

Agenda:

• IVDR news on transition, Expert Panel and Finland reminder
• Clinical Trial Regulation in EU and UK
• Training EU MDR 2017/745
• EUDAMED Certificate module
• EU Reinforced role for EMA on medical device and medicinal product shortage
• Harmonized Standards
• Annex XVI Draft
• Switzerland Good Reprocessing Practices
• Re-registration within MHRA
• Bahrain medical device that doesn’t need registration
• Newsltetter: FDA Medsun and Japan PMDA
• MDCG guideline
• Notified Body situation
• EMD Podcast

LINKS

IVDR

• IVDR: (EU) 2022/112 : https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R0112&from=EN
• Expert Panel: Performance Evaluation: https://ec.europa.eu/health/medical-devices-expert-panels/experts/list-views-provided-and-ongoing-consultations-under-pecp_en
• Finland – FIMEA: At home-test Covid 19: https://www.fimea.fi/web/en/-/fimea-reminds-importers-and-distributors-of-covid-19-at-home-tests-of-the-special-requirements-related-to-the-tests
• Clinical
• Regulatory harmonization of clinical trials in the EU: Clinical Trials Regulation to enter into application and new Clinical Trials Information System to be launched https://www.ema.europa.eu/en/news/regulatory-harmonisation-clinical-trials-eu-clinical-trials-regulation-enter-application-new
• UK: Consultation on proposals for legislative changes for clinical trials https://www.gov.uk/government/consultations/consultation-on-proposals-for-legislative-changes-for-clinical-trials

Training

• Green Belt Certification Program Edition 16: February 21st to February 25th: https://school.easymedicaldevice.com/course/gb16/

Divers

• EUDAMED Certificates module: https://ec.europa.eu/tools/eudamed/#/screen/certificates
• Podcast episode 111 with Leon Doorn: https://podcast.easymedicaldevice.com/111/
• EU – REINFORCED ROLE FOR THE EUROPEAN MEDICINES AGENCY  IN CRISIS PREPAREDNESS AND MANAGEMENT  FOR MEDICINAL PRODUCTS AND MEDICAL DEVICES https://data.consilium.europa.eu/doc/document/PE-76-2021-REV-1/en/pdf
• Harmonized Standards (New Webpage): https://ec.europa.eu/health/medical-devices-topics-interest/harmonised-standards_en
• European Commission: Draft Common Spec Annex XVI Consultation page: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/11629-Products-with-an-aesthetic-or-non-medical-purpose-safety-requirements_en
• Switzerland: Good Reprocessing Practices: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing—maintenance/reprocessing.html
• UK Responsible Person: Re-registration of MHRA accounts:  https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
• Bahrain: Which Medical Device should not be registered: https://www.nhra.bh/Media/Announcement/MediaHandler/ImageHandler/documents/Announcements/Announcement2022_Circular%20No.%20(01)%202022_T0%20All%20Medical%20Devices%20Companies%20and%20Healthcare%20Facilities_Cases%20that%20Will%20Not%20be%20Included%20in%20Medical%20Devices%20Regulation_20220119.pdf

Newsletter

• USA: Medsun Newsletter January 2022: https://www.fda.gov/media/155206/download
• PMDA Japan: https://www.pmda.go.jp/files/000244668.pdf

Guidance:

• MDCG 2022-1: Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices https://ec.europa.eu/health/document/download/cd617093-f2bd-4a99-9058-9805ce4d0db3_en
• MDCG 2022-2 General principle of Clinical Evidence for IVDs: https://ec.europa.eu/health/latest-updates/mdcg-2022-2-guidance-general-principles-clinical-evidence-vitro-diagnostic-medical-devices-ivds-2022-01-27_en

Notified Body

• ITALCERT SRL EU MDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=315596&version_no=10

PODCAST:

• Episode 162: How to accelerate your laboratory test results? https://podcast.easymedicaldevice.com/162/
• Episode 163: How to interview a QA RA Candidate? https://podcast.easymedicaldevice.com/163/
• Episode 164: MDCG 2021-27: https://podcast.easymedicaldevice.com/164/

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The MDCG 2021-27 on Articles 13 and 14 of the EU MDR 2017/745 is creating some problems because of the vocabulary used. Erik Vollebregt, a lawyer at Axon Lawyers is helping us to understand the problem some vocabulary used can generate. In this case, we will focus on 2 of the elements: - Placing on the market - Importer relabelling. Don't hesitate to look at the show notes for more details.

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/2021/12/28/mdcg-2021-27-qa-on-importers-and-distributors-sort-of-box-of-chocolates/

■ MDCG 2021-27: https://ec.europa.eu/health/system/files/2021-12/mdcg_2021-27_en.pdf

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If you are a Quality or Regulatory affairs hiring manager then you may need to understand how to interview your candidates. I have asked Mitch Robbins from the Anthony Michael Group which is a Recruiting Agency to help us with some techniques.

Mitch Robbins will explain to you how to prepare prior to the interview, what kind of information you need to identify during the interview and what is the activities after. If you follow that, you will have a high chance to recruit the right candidate for your organization. I hope this will help you.

Who is Mitch Robbins?

Mitch Robbins is the Founder and Managing Director of The Anthony Michael Group in a suburb of Denver, CO. Mitch and his team at AMG helps organizations (Med-Device, Diagnostics, and Digital Health) to hire the top 15% of Elite Technical Talent in areas like Regulatory Affairs, Quality, Engineering, R&D, Manufacturing and Operations. Mitch, himself, is consistently ranked across the world within the top 1% of Headhunters and has been the choice of the experts to deliver training to both rookies and seasoned recruiters across multiple disciplines on numerous occasions.

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 from the Video

Mitch´s Linkedin Profile: https://www.linkedin.com/in/mitchrobbins/

The Anthony Michael Group: https://theanthonymichaelgroup.com

Episode: Be the best candidate ever: https://podcast.easymedicaldevice.com/38/

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I am sure you were in this situation where you had to execute some Laboratory Tests for the compliance of your medical device and thought that you just need to contact them so they can execute the test. But the reality is different. They may ask you a lot of questions that you don’t understand. So on this podcast episode, we help you define the best process for you to approach a Laboratory with the support of Christoph Lindner from TÜV SÜD. He will share with us his knowledge and tips for you to accelerate your lab test results.

► Who is Christoph Lindner?

Christoph Lindner is the Team Leader for Medical Device testing at TÜV SÜD. He has a Ph.D. in Organic Chemistry. His career in the industry was on ophthalmology products and also on Laboratory testing. Before being in charge of the Medical Device testing at TÜV SÜD he first became a Notified Body Auditor which helps him to have a clear understanding of the regulatory requirements.

► 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 is now in charge of the consulting firm Easy Medical Device in Switzerland, Belgium, and the UK and developed many ways to deliver knowledge through Videos, podcasts, online courses… He offers also the service of an Authorized Representative for his customers.

► Links:

Christoph Lindner LinkedIn Profile: https://www.linkedin.com/in/christoph-lindner-a274aba1/

TÜV SÜD Laboratory Test Services: https://podcast.easymedicaldevice.com/wp-content/uploads/2022/01/TUV-SUD-testing-services_one-pager.pdf

TÜV SÜD Website: https://www.tuvsud.com/en-us/services/testing

EU MDR 2017/745 Green Belt Training: https://easymedicaldevice.com/gb

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Happy New Year 2022. All my best wishes for this year. For all the updates. check the links below.

• Green Belt Edition 15 – January 2022: http://school.easymedicaldevice.com/course/gb15/
• Progressive Roll-out of the In Vitro Diagnostic Medical Devices Regulation: https://ec.europa.eu/commission/presscorner/detail/en/IP_21_6965
• 02 Expert Panel Review: Screen donor samples for HEV RNA in plasma samples https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/pecp-ivd-2021-000002-view_en.pdf
• 03 Expert Panel Review: Detection of West Nile Virus (WNV) RNA in plasma and serum specimens. https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/pecp-ivd-2021-000003-view_en.pdf
• 04 Expert Panel Review: Test for direct detection of Babesia DNA and RNA in whole blood samples: https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/pecp-ivd-2021-000004-view_en.pdf
• 05 Expert Panel Review: Qualitative in-vitro nucleic acid screening test for the direct detection of ZIKA virus RNA in human plasma [RECOMMENDATION PROVIDED]: https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/pecp-ivd-2021-000005-view_en.pdf
• MDCG 2022 meetings: https://ec.europa.eu/health/sites/default/files/md_dialogue/docs/md_events_2022_en.pdf
• Team NB Position paper on MDR/IVDR Implementation: https://www.team-nb.org/wp-content/uploads/2021/12/Team-NB-PositionPaper-on-MDR_IVDR-Implementation-V2.pdf
• eIFU: https://eur-lex.europa.eu/eli/reg_impl/2021/2226/oj
• The Fast-Track Process for DiGA: https://www.bfarm.de/SharedDocs/Downloads/EN/MedicalDevices/DiGA_Guide.pdf?__blob=publicationFile
• Swissmedic Simplifies labeling Obligations: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/mu600_00_016d_mb_pflichten_wirtschaftsakteure_ch.pdf.download.pdf/MU600_00_016d_MB_Pflichten_Wirtschaftsakteure_CH.pdf
• QUNIQUE translation: https://lnkd.in/ghreiitJ
• Swiss notification mandate form updated: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/formular-mandat-chrep.html
• Medsun December 2021: Reporting of problems from 300 hospitals, nursing homes, and home health facilities in the USA. https://www.fda.gov/media/154761/download
• Medical Device Regulation Overview and update – Eng Abdullah Alghuraibi: http://www.ahwp.info/sites/default/files/Annex18_Saudi%20Arabia%20updates.pdf
• DoC template: https://www.sfda.gov.sa/sites/default/files/2021-12/MDMA-Annex15v6.docx
• EU: MDCG 2021-27 Questions and answers on article 13 & 14 of MDR & IVDR: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-27_en.pdf
• Erik Vollebregt Article: https://medicaldeviceslegal.com/2021/12/28/mdcg-2021-27-qa-on-importers-and-distributors-sort-of-box-of-chocolates/
• EU: MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-28_en.pdf
• TÜV NORD CERT GmbH: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=315449&version_no=26
• Episode 158: Which devices cannot be Custom-made [Erik Vollebregt]: https://podcast.easymedicaldevice.com/158/
• Episode 159: The Step-by-step recipe to get MDR and IVDR certified: https://podcast.easymedicaldevice.com/159/
• Episode 160: What happened in 2021: https://podcast.easymedicaldevice.com/160/

• 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

The post Medical Device News – January 2022 [Happy New Year] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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The year 2021 was really full of updates for the Medical Device Industry. I can understand that it goes so fast you cannot follow. So I tried to summarize the year 2021 and also tell you some objectives that we are planning for 2022. So I hope this will give you some important information.

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…

• 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

The post What happened in 2021? Summary for the Medical Device Industry appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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

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For this episode, I wanted to show you how it is possible to plan your MDR & IVDR certification. This is a question that people ask me when they reach out. “What should I do to get ready for MDR or IVDR certification?”

So here we will talk about:

• Quality Management System
• Technical Documentation
• Clinical Evaluation
• Audit readiness
• Audit completion
• Certification

I hope this will help you in your process. In case you need support don’t hesitate to reach out. My team and I are ready to help you.

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…

• 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

The post The Step-by-Step recipe to get MDR & IVDR Certified appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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

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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 for 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.”

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…

• Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/
• Axon Lawyers: https://www.axonlawyers.com/
• Erik’s blog: https://medicaldevicelegals.com
• MDCG 2021-3: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-3_en.pdf

The post Which devices cannot be Custom-made? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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