Easy Medical Device Podcast

https://www.youtube.com/embed/g1QbJ7hLG4Q?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

• EUDAMED
  • Commission implementing regulation 2021/2078: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2078
  • EUDAMED webpage: https://ec.europa.eu/health/md_eudamed/udi_devices_registration_en
  • EUDAMED Playground: https://webgate.training.ec.europa.eu/eudamed-play/landing-page#/
  • UDI/Devices guidance: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed_udi-devices-user-guide_en.pdf
  • Infographic EUDAMED: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-udi-concept_en.pdf
  • Categorization of devices: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-devices_en.pdf
  • Registration process: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-udi-registration-process_en.pdf
• IVDR expert panel
  • View in the context of the Performance Evaluation Consultation Procedure (PECP): https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/pecp-ivd-2021-000002-view_en.pdf
  • Following MDCG 2021-22 https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-22_en.pdf
• EU Reference laboratories (EURL)
  • Feedback on Draft implementing regulation open until December 17th, 2021: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13272-EURL-fees_en
• Germany: Contact Persons for Medical Devices https://www.bfarm.de/EN/Medical-devices/Contact-persons/_artikel.html?nn=968830
• Ireland – HPRA: In-house Manufacturing of in vitro diagnostic medical devices – Survey
  • Due December 17th, 2021 http://www.hpra.ie/homepage/medical-devices/news-events/item?t=/in-house-manufacturing-of-in-vitro-diagnostic-medical-devices-stakeholder-survey&id=07891026-9782-6eee-9b55-ff00008c97d0
• Ireland – HPRA: Update on the creation of Free Sale Certificate in Ireland: http://www.hpra.ie/homepage/medical-devices/news-events/item?t=/applying-for-a-certificate-of-free-sale-updated-information&id=d4731026-9782-6eee-9b55-ff00008c97d0
• Annex XVI products – Finland – FIMEA
  • https://www.fimea.fi/web/en/-/supervision-of-devices-referred-to-in-annex-xvi-of-the-medical-device-regulation-to-begin-in-autumn-2022
• CHRISTMAS BREAK
  • MHRA Christmas period: Clinical Investigation: https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device
  • Belgium – FAMHP – Christmas period https://www.famhp.be/en/news/deadlines_for_the_submission_of_dossiers_during_end_of_year_period
• Switzerland: Registration of Economic Operators: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/registriernummer-chrn.html
  • CH-RN Database: https://opendata.swiss/en/dataset/mep401-chnr-actors
  • How to obtain the CHRN: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_11_001defi_fo-registrierungsantrag-einmalige-idnr-art55-mepv.pdf.download.pdf/BW630_11_001defi_FO_Antrag_Registrierung_CHRN.pdf
• Switzerland – Procurement: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing—maintenance/beschaffung.html
• UK MHRA: Review launched into the health impact of potential bias in medical devices : https://www.gov.uk/government/news/review-launched-into-the-health-impact-of-potential-bias-in-medical-devices
• WORLD
  • USA: Final rule for Medical Device De Novo Classification Process
    • https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-rule-medical-device-de-novo-classification-process
    • Podcast episode 43 – How to register a Medical Device with FDA? (510k, PMA, DeNovo) How to register a Medical Device with FDA? (510k, PMA, de Novo…)
  • USA: Draft Guidance 510K Device Software function SaMD
    • Webinar Dec 16th, 2021 – Draft Guidance: Content of Premarket Submission for Device Software functions: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-draft-guidance-content-premarket-submissions-device-software-functions-12162021-12162021
    • Draft guidance: https://www.fda.gov/media/153781/download
  • USA: Voluntary eSTAR Program: https://www.fda.gov/medical-devices/premarket-notification-510k/voluntary-estar-program
    • Non-in vitro diagnostic eStar Version 1: https://www.fda.gov/media/154429/download
    • In Vitro Diagnostic eStar Version 1: https://www.fda.gov/media/154430/download
  • Saudi Arabia: Borderline products https://www.sfda.gov.sa/sites/default/files/2021-11/GuidanceBorderlineProductsClassificationE.pdf
• Notified Body
  • SGS Belgium: https://www.sgs.com/en/news/2021/11/sgs-belgium-nv-confirmed-as-a-notified-body-for-the-new-eu-medical-device-regulation-mdr
  • MDR 25: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
  • IVDR 2017/746 6: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35
• EMD
  • Podcast
    • Episode 153 – How to improve your QA RA Communication with Lesley Worthington: https://podcast.easymedicaldevice.com/153/
    • Episode 154 – Is it possible to Private Label a Medical Device under MDR and IVDR with Erik Vollebregt: https://podcast.easymedicaldevice.com/154/
    • Episode 155 – How to approach your Notified Bodies? With Dr Royth von Hahn https://podcast.easymedicaldevice.com/155/
    • Episode 156 – Unleashing “MDR Classification surprises with Franck Matzek https://podcast.easymedicaldevice.com/156/
  • LinkedIn Live
    • Talk Cybersecurity during MDR audit with Stefan Bolleininger:  https://www.youtube.com/watch?v=IK0DiXnISKE&t=4s
    • IVDR 2017/746 – in-house devices: https://www.youtube.com/watch?v=AbwaA7DpbYI

The post Medical Device News: December 2021 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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Recently the MDCG guidance for Medical Device classification was published. And I wanted to have someone to help us decode it. Frank Matzek accepted to share his knowledge as he worked on the consultation of this guidance and he can tell us if there are some specific elements to look at. The discussion of today will be mainly on the changes related to the new EU MDR 2017/745. We will also discuss a bit of the EU MDD 93/42/EC

Frank Matzek is a Medical Device expert with 40 years of experience. He worked within a Test and Certification body called BerlinCert where he was the technical expert. Then he entered BIOTRONIK as Regulatory Affairs Manager and didn’t leave it until now. He is now the Vice-President of Regulatory & Government affairs. Additionally, Frank is also part of the BVMed as a member and vice-chair of the Regulatory Affairs Committee (AKRA) and lastly member of the MedTech Europe.

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…

• Frank Matzek Profile: https://www.linkedin.com/in/frank-matzek-a43617/
• Biotronik website: https://www.biotronik.com/?campaign=linkedinus
• MDCG 2021-24: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-24_en.pdf
• MEDDEV classification guidance: https://ec.europa.eu/docsroom/documents/10337/attachments/1/translations/en/renditions/native

The post Let’s unleash “MDR Classification surprises” [MDR 2017/745] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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One of the most stressful situations in the medical device business is the selection and the work with Notified Bodies. Why?

Because there are less than what we need and because it is difficult to budget their service. So I have invited the Head of the TÜV SÜD Healthcare Business Unit to tell us more about the Notified Body Situation.

We will discuss:

• The increase of Notified Body Scope
• The Covid Restrictions
• The strategy US – EU for market access
• The cost of Notified Bodies
• When to contact a Notified Body?
• Annex XVI products
• The IVDR proposal to delay some of the product classes
• Sustainability

So if you need to understand better the situation of Notified Bodies and how to work with them then this is the Podcast to listen to.

Dr. Royth von Hahn has taken over as the new Business Unit Manager Medical & Health Services (MHS) at TÜV SÜD Product Service. Operating from San Diego (USA), he will be responsible for a network of around 600 experts and a portfolio of lifecycle services for medical devices, from product design to risk management and approval. Dr von Hahn succeeds Dr. Peter Havel, who transfers to TÜV SÜD Product Service GmbH in Munich as CEO.

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…

• Dr Royth von Hahn profile: https://www.tuvsud.com/en/press-and-media/2018/january/dr-royth-von-hahn-responsible-for-medical-health-services-at-tuv-sud
• TÜV SÜD healthcare: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-regulation/mdr-conformity-assessment-procedures

The post How to approach your Notified Bodies? [Dr. Royth von Hahn – TÜV SÜD] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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If you are a company buying products from a supplier and then putting your brand on it to sell it in Europe, then you are an Own Brand Labeller or Private Labeller, or Virtual Manufacturer.

In this episode, we will discuss this business model and what are the options for you as this is not really possible under EU MDR 2017/745 or EU IVDR 2017/746. Erik Vollebregt will provide some information on some cases where OBL is involved and also explain your choices, like importer or distributor…

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, focusing on contracts, regulatory litigation against competent authorities, and M & 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 a big Healthcare company, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand the Medical Device Regulations worldwide.

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

The post Is it possible to Private Label a Medical Device under MDR & IVDR? 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.