Easy Medical Device Podcast

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Here are all the topics that we will cover during this regulatory update. Don’t forget to contact easy medical device if you need an EU-authorised representative, a Swiss representative or a UK-responsible person.

HOT TOPIC

• Implementing Rolling Plan: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_rolling-plan_en.pdf
• EUROPA IVDR expert panel: https://ec.europa.eu/health/md_expertpanels/overview_en
• EUDAMED Device module https://ec.europa.eu/tools/eudamed/#/screen/home
• Helsinki Procedure 2021: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_border-class_helsinki-proc-mdr-ivdr_en.pdf
• Medtech Europe – Availability of IVD devices in May 2022 https://www.medtecheurope.org/resource-library/medtech-europe-survey-report-analysing-the-availability-of-in-vitro-diagnostic-medical-devices-ivds-in-may-2022-when-the-new-eu-ivd-regulation-applies/
• IMDRF Artificial intelligence: http://www.imdrf.org/docs/imdrf/final/consultations/imdrf-cons-aimd-mlmd-ktd-wgpd-n67.pdf

EMD training

• Green Belt Edition 14: https://school.easymedicaldevice.com/course/gb14/

SWISSMEDIC

• Swissmedic Information session September 2nd, 2021 https://www.swissmedic.ch/swissmedic/en/home/services/veranstaltungen/info-medizinprodukte-regulierung.html
• Swissmedic- Combination products: https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/ch-bevollmaechtigter-kombiprodukte.html

MHRA

• MHRA- Transforming the regulation of Software and artificial intelligence as Medical Devices https://www.gov.uk/government/news/transforming-the-regulation-of-software-and-artificial-intelligence-as-a-medical-device
• Software and AI as Medical Device Change Programme https://www.gov.uk/government/publications/software-and-ai-as-a-medical-device-change-programme/software-and-ai-as-a-medical-device-change-programme
• MHRA Consultation on the future Regulation of Medical Devices in the UK. https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom?utm_medium=email&utm_campaign=govuk-notifications&utm_source=5b7f9b8d-f894-4288-bc55-148816deedd2&utm_content=daily
• MHRA webinar – Consulting on Future of Medical Device Regulation for industry: https://www.eventbrite.co.uk/e/mhra-consultation-on-future-medical-devices-regulation-in-the-uk-industry-tickets-166144503683
• MHRA registration renewal: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#review-registration

SPAIN

• AEMPS – Carlos III Health Institute presents the National Registry of Circulatory and Respiratory Assistance Devices in Spain. https://www.aemps.gob.es/la-aemps/eventos/2021-eventos/presentacion-del-registro-renacer/
• Change of labeling and IFU for Swiss Manufacturers https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2021-productossanitarios/informacion-sobre-productos-sanitarios-en-base-al-acuerdo-de-reconocimiento-mutuo-mra-ue-suiza/

FDA

• USA Device Registration and Listing: https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing
• List of who must register and pay: https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee
• FDA – List of AI and Machine Learning ML devices: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices

NOTIFIED Body

• TÜV Rheinland Italia SRL: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=314154&version_no=8

GUIDANCES

• Borderlines with Medical Devices https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1022543/Rev_Borderlines_with_medical_devices_and_other_products-_V1_4_80_.pdf
• FDA Electronic submission template for Medical Device 510k: https://www.fda.gov/media/152429/download

EMD Nostalgia

• Podcast Episode 144 https://podcast.easymedicaldevice.com/144/
• Podcast Episode 145 https://podcast.easymedicaldevice.com/145/
• Podcast Episode 146 https://podcast.easymedicaldevice.com/146/
• Podcast Episode 147 https://podcast.easymedicaldevice.com/147/

The post Medical Device News – October 2021 Regulatory Update 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 specialized 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://www.axonlawyers.com/author/erikvollebregt/?archive
• MDCG 2021-23 – Article 16(4) https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-23_en.pdf

The post Why does an Importer/Distributor need to appoint a Notified Body? 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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Clinical Data is key for the Medical Device Regulation MDR 2017/745. Today on this Podcast Episode, I have invited Jon Bergsteinsson from Smart Trial. And we will discuss Digital tools to collect data.

• History of Clinical Data Collection
• Difference between Big and small companies
• Use of CRO for collecting data
• Difference on Clinical Investigation and PMCF data collection

So if you still think that we should collect data by hiring people that are going to healthcare facilities and transfer data on paper or excel sheets then you should listen to this episode. The world is changing.

Jon co-founded the company behind SMART-TRIAL and served as the CTO until 2017, where he paved the way for the platform’s quality standard, data security, and compliance. With a background in Biomedical Engineering and 10 years of experience in clinical research and medical devices, Jón is mostly occupied with sharing valuable insights and know-how on clinical data management with the MedTech industry.

Monir El Azzouzi is a Medical Device Expert specialized 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…

• Jon’s LinkedIn Profile: https://www.linkedin.com/in/joningib/
• Smart-trial: https://www.smart-trial.com/

The post How to collect Clinical Data within the 21st Century [Jon Bergsteinsson] 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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We are at 9 months of the EU IVDR 2017/746 date of application. So let’s t talk of the Transition period for such products. We have done that also for MDR 2017/745 when the date was nearly due.

So today we’ll tell you about:

• Differences between IVDD 98/79/EC and IVDR
• The Hard Transition Period – The Soft Transition Period
• The UDI transition period – The Notified Body situation
• A simulation on submission timeline to a Notified Body

If you have any need of support for your projects don’t hesitate to contact me. I am sure we can help you.

Monir El Azzouzi is a Medical Device Expert specialized 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…

• Monir El Azzouzi LinkedIn: https://www.linkedin.com/in/melazzouzi/
• Episode 99 – Self-testing: https://podcast.easymedicaldevice.com/99
• Episode 121 – Why will it be difficult for IVDR manufacturers: https://podcast.easymedicaldevice.com/121
• Nando Database IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35
• Nando Database IVDD: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=20
• Q&A Covid19 Tests: https://ec.europa.eu/health/sites/default/files/md_sector/docs/covid-19_ivd-qa_en.pdf

The post How to manage the IVDR transition period? [IVDR 2017/745] 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.

https://www.youtube.com/embed/Aflq1dNad-U?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

First of all, I am not encouraging anyone to sue anyone. This is only educative content to know what is possible and what is the best strategy to do it.

We will talk about the reason one company would sue its Notified Body and also about the good method and the bad method to do it. Some of the discussions are based on real-life experience. Anyway, one of the pieces of advice is to hire a lawyer specialized in Healthcare legislation so they can really understand how all this is working.

Long-life to Notified Bodies… !!!

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.”

Monir El Azzouzi is a Medical Device Expert specialized 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…

• Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/
• Axon Lawyers: https://www.axonlawyers.com/
• Erik’s blog: https://www.axonlawyers.com/author/erikvollebregt/?archive

The post Is it a good idea to sue my Notified Body? [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.