Easy Medical Device Podcast

https://www.youtube.com/embed/6pQtv7MPIag?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

This week I had some exciting moment when I followed the EU parlement webcast on the April 17th, plenary session to see what they will decide about the proposal to delay the EU MDR until May 26th, 2021.

Already in the morning we had a first vote with some good result. And at the end of the day it was confirmed. The EU parliament adopted the proposal.

Now in this episode we will come back on the context and the consequences of this vote for the Medical Device Industry.

Erik Vollebregt and I followed these last weeks the situation and want now to provide you some answers as I get a lot of questions.

Some of the topics that we will discuss are the consequence to:

• EUDAMED
• Article 59 of the EU MDR and 54 of the EU IVDR
• Notified Body situation
• Brexit, Swixit and Turxit
• Economic Operators
• Annex XVI

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 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.”

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

• Erik Vollebregt Linkedin profile: https://www.linkedin.com/in/erikvollebregt/
• Axon Lawyers website: https://axonlawyers.com
• Erik’s blog post on the parliament vote: MDR date of application move: politically a done deal now
• Proposal adopted document: https://www.europarl.europa.eu/doceo/document/TA-9-2020-0053_EN.pdf
• Council secretariat information note: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_7322_2020_INIT&from=EN
• A general overview of procedure for the amendment: https://eur-lex.europa.eu/legal-content/EN/HIS/?uri=COM:2020:144:FIN
• Parliament decides to postpone new requirements for Medical Devices: https://www.europarl.europa.eu/news/en/press-room/20200415IPR77113/parliament-decides-to-postpone-new-requirements-for-medical-devices
• Blog post: MDR amendment proposal Article 120(3) oversight set to be fixed by Council: https://medicaldeviceslegal.com/2020/04/08/mdr-amendment-proposal-article-120-3-oversight-set-to-be-fixed-by-council/
• Blog post: The MDR amendment proposal: more than meets the eye: https://medicaldeviceslegal.com/2020/04/04/the-mdr-amendment-proposal-more-than-meets-the-eye/
• Blog post- Commission working on a proposal to postpone MDR date of application for one year: https://medicaldeviceslegal.com/2020/03/25/commission-working-on-proposal-to-postpone-mdr-date-of-application-for-one-year/

The post The 1-year delay for the EU MDR 2017/745 with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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This week there was an important vote regarding the proposal to delay the EU MDR until May 26, 2021. The parliament adopted it and we wait for the publication on the official journal. But what will be the consequence for Medical Device Manufacturers, Notified Bodies... The post The 1-year delay for the EU MDR 2017/745 with Erik Vollebregt appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/3i13zimtjJw?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

If you are working for Quality then you maybe experienced this situation. And if you are an employee outside of Quality then we maybe understand why you are doing that.

Monir El Azzouzi and Karandeep Badwal are discussing their experience when it is about hiding problems to the Quality Departments. They will also define the consequences of that and how this can change.

Who is Karandeep Badwal?

Mr. Karandeep Singh Badwal is a Regulatory and Quality Contractor specializing in medical devices, his educational background is an MSc Pharmaceutical Quality by Design, however, has worked almost exclusively within the medical devices industry from multinational companies to startups since his graduation.

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

• Karandeep Badwal LinkedIn Profile: https://www.linkedin.com/in/karandeepbadwal/
• What is Quality for Monir El Azzouzi? : https://easymedicaldevice.com/what-is-quality/

The post Medical Device School – Why are Staff hiding problems to QA & RA? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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If you are not working in QA RA you maybe don't understand this. But sometime people don't want to follow the process not because they want to annoy you but because they are afraid of some consequences. And they try then to find other ways. Let's explore them with Karandeep Badwal The post Medical Device School – Why are Staff hiding problems to QA & RA? appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/x-MZElb-ur0?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

This episode will be really interesting for the pharmaceutical companies that are producing Drug-Device combination products as it explains the consequence of EU MDR Article 117 for their products.

For all projects that are ongoing, you need to consider the new requirements coming from EU MDR as this is amending the 2001/83/EC Medicinal Product Directive.

Theresa Jeary will be my guest during this episode, and her experience with Drug-Device products and as a former Notified Body assessor will help you understand what are the deliverables you should provide now.

We will also discuss the importance of the Notified Bodies during this process as the pharma industry is not really used to deal with this kind of third party entity.

Finally, Theresa prepared a document that you can download below. It will provide you with a summary of the situation for Drug-Device combination products when it comes to the EU MDR.

Who is Theresa Jeary?

Theresa has over 30 years’ experience working in both the Pharmaceutical and Medical Device industries and has been involved in the development of many commercially available medicinal and medical device products.

Theresa has over 12 years of Notified Body experience, initially at BSI as a technical expert for devices with ancillary medicinal substance and she held the position of Head of Notified Body at the UK NB LRQA until January 2019.

Her core area of technical expertise is in the combination product area and Theresa now works as a consultant to the Pharmaceutical and Medical device sectors supporting Companies in meeting regulatory requirements. Theresa is a frequently invited speaker on the medical device legislation and combination products.

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…

Links

• Theresa Jeary LinkedIn Profile: https://www.linkedin.com/in/theresa-jeary-09bb7226/
• Template Drug-Device Technical Documentation: https://school.easymedicaldevice.com/product/drug-device-tech-doc/
• Download Presentation: https://mailchi.mp/easymedicaldevice/article_117
• How to classify a Medical Device: https://easymedicaldevice.com/new-eu-medical-device-classification/
• FAQ EMA Article 117: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu/745-eu-2017/746_en.pdf

The post MDR & Drug-Device Combination Products with Theresa Jeary appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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Did you know that the EU MDR is amending 2001/83/EC for Medicinal Products. This may have some consequences for your products if it involves a Drug-Device combination. Monir El Azzouzi and Theresa Jeary are explaining to you what should be done. The post MDR & Drug-Device Combination Products with Theresa Jeary appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/XDN1PoDveuQ?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

In this episode of the Podcast, I will provide you with the situation for the month of march 2020 and what should happen next.

As you may know we are in the beginning of a pandemic and this is really a stressful situation for all countries worldwide. So this episode will also show you some elements that should be interesting for you to know during this period.

We will also discuss about the Notified Body Situation. There is a new Notified Body that was announced but this is not enough. We need more. Let’s see the numbers.

I will also list the MDCG guidances and regulatory updates that were released.

Finally, we will review what happened at Easy Medical Device during that month.

Don’t miss the links with all the source of information

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…

Links from the Video

• Coronavirus
  • DoA delay 1 year: https://audiovisual.ec.europa.eu/en/video/I-187348
  • Proposal for extension of MDR DoA to + 1 year: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1585914772359&uri=COM:2020:144:FIN
  • Erik Vollebregt Blog Post: https://medicaldeviceslegal.com/2020/04/04/the-mdr-amendment-proposal-more-than-meets-the-eye/
  • Notified Body audits suspended: https://www.dakks.de/en/content/dakks-adopts-safety-measures-suspension-site-assessments
  • Coronavirus impact on the Medical Device Industry: Medical Device Industry impact due to Coronavirus Outbreak (EU MDR): https://youtu.be/_m3egM0HEns
  • MHRA guidance: https://www.gov.uk/guidance/mhra-regulatory-flexibilities-resulting-from-coronavirus-covid-19
  • Free Standards available for Covid19 products: https://www.cencenelec.eu/News/Press_Releases/Pages/PR-2020-003.aspx
• Notified Body Situation
  • State of play March 2020: https://ec.europa.eu/docsroom/documents/40341?locale=en
  • MDR 2017/745 NB: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
  • IVDR 2017/746 NB: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35
• Regulatory Updates
  • Harmonized Standard update for MDD 2020/437: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1585235207379&uri=CELEX:32020D0437
  • Harmonized Standard update for AIMDD 2020/438: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1585235819491&uri=CELEX:32020D0438
  • Harmonized Standard update for IVDD 2020/439: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1585235896183&uri=CELEX:32020D0439
  • MDCG Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software 2020-1: https://ec.europa.eu/docsroom/documents/40323?locale=en
  • MDCG Guidance Class Transitional Provision under Article 120(3 and 4) 2020-2: https://ec.europa.eu/docsroom/documents/40324?locale=en
  • MDCG Guidance Significant Change 2020-3: https://ec.europa.eu/docsroom/documents/40301/attachments/1/translations/en/renditions/native
• Easy Medical Device podcasts
  • Episode 67 – Cybersecurity with Erik Vollebregt: https://podcast.easymedicaldevice.com/67/
  • Episode 68 – Class Is, Im and Ir with Elem Ayne: https://podcast.easymedicaldevice.com/68/
  • Episode 69 – Significant Changes with Erik Vollebregt: https://podcast.easymedicaldevice.com/69/
• LinkedIn Live
  • How to classify a Medical Device: How to classify a Medical Device? (EU MDR Case Studies): https://youtu.be/JXuLft-IEZg
  • FAQ on Economic Operators with Erik Vollebregt: FAQ Medical Device Economic Operators? (EU MDR and IVDR): https://youtu.be/qvOyEofrhgk
  • Coronavirus outbreak with Erik Vollebregt, Bassil Akra, and Gert Bos: Medical Device Industry impact due to Coronavirus Outbreak (EU MDR): https://youtu.be/_m3egM0HEns

The post Medical Device News – March 2020 Review (EU MDR) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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The month of March 2020 is over but there was a lot of information provided regarding the Medical Device industry so let's listen to the different news with Monir El Azzouzi The post Medical Device News – March 2020 Review (EU MDR) appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/lzpJnvN5FoM?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

This is a topic that all of you are talking about. What is a Significant Change to your Medical Device?

I may say, it depends and this is also the answer of Erik Vollebregt who is my guest in this episode of the Podcast.

He will help us understand what you should consider a Significant Change and also provide some examples like for Software companies or also for a change of suppliers or finally during a Merger and Acquisition.

Why is this is so important? Because this would have an impact on your transition period. If you have an MDD certificate that expires after May 26, 2020, then you can benefit from a transition period where you can still supply your medical devices even if they have not transitioned to EU MDR.

But if your device is having a Significant Change during this period, then the transition period stops for it. It immediately falls under EU MDR. So it is important for Medical Device Manufacturers to understand this concept and plan a strategy for it.

After the recording of this episode, the MDCG finally released the guidance expected. I put the link below. This is based on some documents that we discussed during this episode. All that was covered in this episode is not changed due to this guidance.

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 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.”

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…

Links

• Erik Vollebregt LinkedIn Profile: https://www.linkedin.com/in/erikvollebregt/
• Axon Lawyers website: https://axonlawyers.com
• Erik Vollebregt Blog on Significant Change: https://medicaldeviceslegal.com/2020/03/21/the-mdcg-guidance-on-significant-changes-a-significant-change/
• CAMD FAQ question – MDR Transitional provision: https://www.camd-europe.eu/wp-content/uploads/2018/05/FAQ_MDR_180117_V1.0-1.pdf
• LNE GMED guidance: http://www.lne-gmed.com/en/guides/free-guide-change-EC-framework.asp
• Medtech Europe – Joint Industry Position on Significant Changes according to MDR Article 120(3): https://wp.me/a9JvWo-TH
• MDCG 2020-3 Guidance significant change: https://ec.europa.eu/docsroom/documents/40301

The post What is a Significant Change for your Medical Device? with 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.

This is an important question if you understand the rule for a transition period of your device under EU MDR article 120(3). If you perform a significant change then you may be prepared for the consequences. Let's see what are the advice of Erik Vollebregt if you reach this situation. The post What is a Significant Change for your Medical Device? with Erik Vollebregt appeared first on Medical Device made Easy Podcast.