Easy Medical Device Podcast

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MDR is coming In 1 week and before that, I asked Erik Vollebregt from Axon Lawyers about some questions that I receive. We will talk about: – EU MDR IVDR postponement or not? – Economic Operators date of application – PRRC do we need it from day 1 – Exclusion from EU MDR – OEM OBL rules from May 26th, 2021 And Erik announces the content of its book that will be released soon. You will see on the following sections the links related to the topic we have discussed.

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 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…

Links from the Video

• 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
• Qserve talks: https://open.spotify.com/episode/0iD2WYmfxzHYNpHvv6QH5J?si=iJtTJaUMTMGvecBUmfE3oQ
• Blue Guide: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52016XC0726(02)&from=BG
• Easy Medical Device Shop: https://easymedicaldevice.com/shop

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1 week to the EU MDR and we hope that you are ready. If not, then you can maybe listen to this episode as we are answering some last minute questions. The post MDR is coming so brace yourself with Erik Vollebregt appeared first on Medical Device made Easy Podcast.

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In this episode of the Podcast, we will explain to you what is the Emergency Use Authorization (EUA) that can be started in the US. And to help us, I have invited Michelle Lott from Lean RAQA.

This process was used a lot recently for Coronavirus products but you will see with Michelle that this process was changed so many times that it can create some headache.

Who is Michelle Lott?

Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Device Good Manufacturing Practices Advisory Committee and is a vocal advocate of EU MDR readiness. Michelle serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries. She has a weakness for tequila and anything barbecued.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company 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, Podcast, Online courses…

Link

• Michelle Lott Linkedin Profile: https://www.linkedin.com/in/michellelottraqa/
• Lean RAQA website: https://leanraqa.com/
• FDA EUA Guidance: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

The post FDA: Is the Emergency Use Authorization worth it? (EUA) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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This process called EUA was really famous last year when everyone wanted to register its face mask or respirator or covid-19 test in the USA. After 1 year let's see the conclusion of Michelle Lott on it. The post FDA: Is the Emergency Use Authorization worth it? (EUA) appeared first on Medical Device made Easy Podcast.

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Who is Monir El Azzouzi?

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…

Links

■ HOT

• Updated Implementing Plan: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_rolling-plan_en.pdf
• Expert Panel: https://ec.europa.eu/health/md_expertpanels/overview_en
• Factsheet for manufacturers of Implantable Medical Devices https://ec.europa.eu/health/sites/health/files/md_topics-interest/docs/md_implany-cards_factsheet_en.pdf
• MDCG 2019-8 v2. Guidance Implant Card https://ec.europa.eu/docsroom/documents/40321/attachments/1/translations/en/renditions/native
• Factsheet for class I medical devices: https://ec.europa.eu/health/sites/health/files/md_topics-interest/docs/md_mdcg_2021_factsheet-cl1_en.pdf
• MHRA Certificate of Free Sale Reference Guide: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/978388/Certificates_of_Free_Sale_Reference_Guide_April_2021_Final_v1.pdf

■ Standardisation

• IVDD Harmonized Standard: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021D0609
• MDD Harmonized Standard: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021D0610
• AIMDD Harmonized Standard: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021D0611
• Standardisation page: https://ec.europa.eu/growth/tools-databases/mandates/index.cfm?fuseaction=search.detail&id=599#

■ Notified Bodies

• Team Notified Body Survey: https://www.team-nb.org/wp-content/uploads/2021/04/Team-NB-MD-Sector-Survey-PressRelease-20210414.pdf
• NB Eurofins expert service Oy (Finland): https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=311931&version_no=5

■ Guidance and Standards

• MDCG 2018-1 Guidance on UDI-DI and Basic UDI-DI https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2018-1_guidance_udi-di_en.pdf
• MDCG 2021-6 Q&A regarding clinical investigation: https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_2021-6_en.pdf
• MDCG 2021-4 Application of transitional provisions for certification of Class D in vitro Diagnostic medical devices according to EU MDR 2017/745 https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_2021-4_en.pdf
• ISO/TS 37137:2021 Biological Evaluation of Absorbable medical devices https://www.iso.org/standard/73582.html

■ Podcast/Live

• Episode 123: How to write a Performance Evaluation with Hakan Inan: https://podcast.easymedicaldevice.com/123/
• Episode 124: How to perform correctly a Merger & Acquisition during the MDR transition with Erik Vollebregt? https://podcast.easymedicaldevice.com/124/
• Episode 125: Checklist – What is important before the EU MDR DoA? https://podcast.easymedicaldevice.com/125/
• LinkedIn Live – All about PMCF with Cesare Magri: All about PMCF with Cesare Magri [EU MDR 2017/745]

■ TELEGRAM GROUP: https://t.me/easymedicaldevice

The post Medical Device News – May 2021 Update [EU MDR 2017/745] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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This is the last month before the EU MDR 2017/745 Date of Application. We will talk about that and about all the updates The post Medical Device News – May 2021 Update [EU MDR 2017/745] appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/8qSqbqnqZOU?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Wahoo!! We are close to it now. The EU MDR 2017/745 Date of Application is arriving quickly. So for this episode, I wanted to check with you if you are ready.

I will provide you first with the Scope for this date. Which products have to be ready by May 26th, 2021. Then we will talk about the documents that should be available. This list may not be complete so be sure to review for your product the requirements on the EU MDR. Finally we will talk about what is not mandatory even if people say it is.

Don’t miss also the links that I will provide below as this will help you to understand each of the topics.

Who is Monir El Azzouzi?

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 developed the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links

• Article 117 Drug Device Combination products : https://www.youtube.com/watch?v=x-MZElb-ur0
• Annex XVI products: https://www.youtube.com/watch?v=kpIphE2PVew
• QMS implementation for EU MDR: https://www.youtube.com/watch?v=HYZJn23C3oc
• Clinical Evaluation for low risk devices: https://www.youtube.com/watch?v=rGHXBYxvMqQ
• CER with Product equivalency: https://www.youtube.com/watch?v=xIeL297EOho
• PMCF with Helene Quie: https://www.youtube.com/watch?v=Avhbglq5bvY
• Podcast episode Q&A label: https://www.youtube.com/watch?v=ecigFjReuXU
• How to create a UDI: https://www.youtube.com/watch?v=_kF5GUs_hgo
• Technical Documentation blog: https://easymedicaldevice.com/technical-documentation/
• Declaration of conformity: https://easymedicaldevice.com/declaration-of-conformity/
• Complete guide on Economic Operators: https://easymedicaldevice.com/economic-operators/
• Swixit, Turkxit, Brexit: https://www.youtube.com/watch?v=ym2bQoe620s
• EUDAMED registration: https://www.youtube.com/watch?v=z5KtpAVV-24

The post Checklist – What is important before the EU MDR Date of Application? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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It is Day -30 for the EU MDR date of application. So let's summarize what should be ready for you and also what is not mandatory. The post Checklist – What is important before the EU MDR Date of Application? appeared first on Medical Device made Easy Podcast.

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Merger and Acquisition sound like a financial topic but you’ll see that all the ways lead to Quality and Regulatory Affairs.

In this episode, Erik Vollebregt, Partner at Axon Lawyers will be helping us to understand why you should have some Quality and Regulatory affairs knowledge when you are running a Merger and Acquisition with a Medical Device company. This may be also more difficult due to the EU MDR transition period. So listen carefully.

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 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…

Links

• Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/
• Axon Lawyers website: http://www.axonlawyers.com/
• EU MDR 2017/745: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1589797311848&uri=CELEX:02017R0745-20200424
• Blog Post: Merger and Acquisition: https://easymedicaldevice.com/medical-device-compliance-merger-acquisition/
• Telegram Group: https://t.me/easymedicaldevice

The post How to perform correctly a Merger & Acquisition during the MDR transition? 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.

Merger and Acquisition is an important topic to understand as people think this is a fiance activity. But when you'll listen to this episode, you will not think that anymore. The post How to perform correctly a Merger & Acquisition during the MDR transition? appeared first on Medical Device made Easy Podcast.