Finally, a proposal is now available, and we wanted to discuss it and identify if there are any surprises. Erik Vollebregt from Axon Lawyer is helping us understand all this.

This proposal is also under consultation until January 18th, 2023. So don’t miss that as this is tomorrow for those seeing the episode today.

To conclude, this is only a proposal, so this is not approved. We are still waiting for the vote. Without this vote nothing is real.

Who is Erik Vollebregt?

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and the protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and 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 in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical device-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 better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device has become a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links

• Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt

In the Medical Device world, you need to work as a team. Sometimes it is really difficult and we will discuss that with Omar M. Khateeb. The relationship between Marketing and QA RA is one of those examples. One is willing to sell creatively and the other is trying to avoid any legal issues. So how should this be balanced? Don’t miss this episode to learn more about how you should interact with other team members within your industry.

Who is Omar M. Khateeb?

Omar is a MedTech marketing and sales professional who founded Khateeb & Co which helps MedTech companies grow their sales pipeline and drive product adoption at scale using social media. Having spent over a decade in disruptive technology ranging from robotics and AI to software, Omar uses his skills around persuasion, technology adoption, and category design to help companies get traction in the market.

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 better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links

• Free Webinar on Using Digital in Medical Sales: https://www.khateebandco.co/ht-1

EU MDR extension

• Implementation of the Medical Device Regulation https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf

Implementing rolling plan

• Implementation Rolling Plan: Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – Latest update: November 2022 https://health.ec.europa.eu/system/files/2022-12/md_rolling-plan_en.pdf

Borderline manual

• Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 – Version2 – December 2022 https://health.ec.europa.eu/latest-updates/manual-borderline-and-classification-under-regulations-eu-2017745-and-2017746-version2-december-2022-2022-12-15_en

Team NB

• AI act for Notified Bodies – Team-NB Position Paper – The designation of notified bodies under the upcoming Artificial Intelligence Act https://www.team-nb.org/wp-content/uploads/members/M2022/Team-NB PositionPaper-AI Designation-V1-20221216.pdf

Notified Bodies appointed

• QMD Services GmbH (NB 2962), 8th Notified Body designated under IVDR (EU) 2017/746 https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=320456&version_no=1

UK Approved bodies

• UK Approved bodies. https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for-medical-devices

Training to attend and Books to read

• Green Belt 24th Edition : https://school.easymedicaldevice.com/course/gb24/

MDCG 2022-17

• MDCG position paper on ‘hybrid audits’ – December 2022 https://health.ec.europa.eu/latest-updates/mdcg-2022-17-mdcg-position-paper-hybrid-audits-december-2022-2022-12-06_en

MDCG 2022-18

• MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of an MDR certificate https://health.ec.europa.eu/latest-updates/mdcg-position-paper-application-art97-mdr-legacy-devices-which-mddaimdd-certificate-expires-issuance-2022-12-09_en

MDCG 2022-19 and 20

• Performance study application/notification documents under Regulation (EU) 2017/746 https://health.ec.europa.eu/latest-updates/mdcg-2022-19-performance-study-applicationnotification-documents-under-regulation-eu-2017746-2022-12-12_en

MDCG 2022-21

• Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 https://health.ec.europa.eu/latest-updates/mdcg-2022-21-guidance-periodic-safety-update-report-psur-according-regulation-eu-2017745-december-2022-12-16_en

Switzerland Annex XVI products

• Frequently Asked Questions on medical devices – FAQ MD: Update of the section “Products without medical purpose” https://www.swissmedic.ch/swissmedic/en/home/medical-devices/regulation-of-medical-devices/faq.html

US Product Codes

• Non-Invasive Body Contouring Technologies https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/non-invasive-body-contouring-technologies

SFDA Classification

• Guidelines for classification of medical devices and supplies https://www.sfda.gov.sa/sites/default/files/2022-12/MDS–G008.pdf

PODCAST nostalgia

• Team-PRRC panel discussion https://podcast.easymedicaldevice.com/210-2/

Getting some visibility is the key to growing your LinkedIn Profile. And on this episode, we tell you how to be more visible or help build a community. As always you cannot do that alone so we propose you a challenge at the end.

Who is Karandeep Badwal?

Karandeep Singh Badwal is an independent Quality & Regulatory consultant within medical devices with a specialism in Software as a Medical Device and Artificial Intelligence having initially started his career within traditional devices working with multi-national companies to small-scale startups. He is also the founder of The MedTech Podcast and regularly makes content around medical devices via LinkedIn and his YouTube channel QRA Medical.

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 better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links

• LinkedIn Karandeep Profile: https://www.linkedin.com/in/karandeepbadwal/

On December 9th, 2022, the EU Commission made a proposal to extend the transition period of the EU MDR 2017/745. But some people think this is already done which is not the case.

There was also at the exact moment the publication of the MDCG 2022-18 on Article 97 used to continue placing devices on the market. To clarify all that I have invited Erik Vollebregt from Axon Lawyers to help us understand the situation.

Many things were said, so let's now debunk all the rumors and provide you with some clear understanding.

Who is Erik Vollebregt?

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and the protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and 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 in 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 better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links from the Video

• Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt

Imagine that you have a question to ask the EU Commission, your Notified Body, or any association about being a PRRC. Then this is the episode to listen to. During the Team-PRRC event on November 3 and 4 2022, I was able to record some of the sessions and propose them to you know. Here are the people that were on the panel:

• Bassil Akra, Board Member of Team-PRRC association as the facilitator https://www.linkedin.com/in/bassil-akra-2388b84b/

And here are the questions answered:

• Why a PRRC is needed

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 better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Link

• Team-PRRC association: https://www.team-prrc.eu/

HOT TOPICS

Europe

• Common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
  • https://webgate.ec.europa.eu/regdel/#/implementingActs/7377?lang=en

• Training
  • December 12th until December 16th https://school.easymedicaldevice.com/product/gb

• UK MHRA: Borderline products: how to tell if your product is a medical device: New section added 'Risk classification of medical devices’
  • https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medical-device#risk-classification-of-medical-devices

Rest of the world

• United States: EUA Template for Developers of Antigen Diagnostic Tests (MonkeyPox)
  • https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/monkeypox-emergency-use-authorizations-medical-devices#templates

If you look for an Authorized Representative or Importer in the European area, contact us at [email protected]

PODCASTS

• Episode 205: Your Software/IVD clinical report is completely WRONG! https://podcast.easymedicaldevice.com/205/

Sterilization for medical devices is a critical topic. Now when you are developing your Medical Device, you should start by asking which sterilization process you should follow for your devices because this will lead to the question of which material you should use to build your device… So to help us have a clear understanding of how Sterilization should be defined for your medical devices, I have invited Jane Scally from Trinzo.

Who is Jane Scally?

Jane has supported medical device manufacturers around the world in the areas of quality management systems, remediation, strategic growth and planning, M&A due diligence and integration management, MDR transition, biocompatibility, and sterilization. Jane has Notified Body experience, performing QMS site audits in tandem with technical documentation reviews. These activities supported manufacturers maintaining their certification under the Directives and those transitioning to MDR 2017/745. Jane holds a Bachelor of Science in Applied Biology and Biopharmaceutical Science, a Higher Diploma in Pharmaceutical Business, and a Master of Science in Medical Technology Regulatory Affairs.

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 better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links

• Jane Scally LinkedIn Profile: https://www.linkedin.com/in/jane-scally-b07206a5/

Risk Management is a discipline of its own within the Medical Device field. In ISO 13485, EU MDR 2017/745, IVDR 2017/746, FDA QSR, MDSAP… All of them talk about Risk Management. You should manage your risks. But why is this so important or even critical? This is what we will discuss with Kailash Kalidoss who is a Medical Device Engineer and also a NASA Ambassador. He will share with us his experience.

PS: if your company needs an EU, UK or Swiss Authorized representative or Importer, don’t hesitate to contact Easy Medical Device. See the link below.

Who is Kailash Kalidoss?

The foundation of my professional experience is in consulting for complex MedTech projects, from conceptualization to product release. In my 13+ years of experience, I have worked as a Design control consultant for various leading US-based Medical Device Companies. I’m also certified by AAMI for Medical Quality System Regulations. Currently, I work for a cutting-edge engineering consulting firm based out of the Bay area in California. Academically my career is well rounded with an MBA from a prestigious B-School. Also, I have good exposure to STEM fields through MS and Engineering Bachelor degrees earlier, to effectively complement the B-School erudition. SPECIALITIES: Medical Device Design Control, Verification, and Validation, Software in Medical Devices and SaMD, Quality, Medical Device Regulations BEYOND WORK: Aerospace Educator for Civil Air Patrol, a United States Airforce Auxiliary. NASA Solar System Ambassador.

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 better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links

• Kailash Kalidoss LinkedIn: https://www.linkedin.com/in/kailashkalidoss

You maybe ask yourself how to get to distribute your Medical Device in the US? Then listen to the story of MysteryVibe with their devices. He will answer questions such as: - Why the US market and not the EU? - What was the interaction with consultants for the Quality and Regulatory aspects? - How is it to work with a Quality Management System? - How is the logistic of the product working? - Why perform Clinical Investigations? So I hope this will help you understand the market by listening to the MysteryVibe Journey.

Who is Dr.Soumyadip Rakshit?

Dr. Soum Rakshit is the Co-Founder & CEO of award-winning sexual health company, MysteryVibe. Their mission is to make sexual health accessible to all – across all ages, genders & orientations. In his role as CEO of MysteryVibe, he focuses on pushing the boundaries on R&D, customer experience and supporting their long-term goal of making sexual health an integral part of our overall health. Soumyadip passionately believes that by empowering people with actionable knowledge & purposeful innovation is the way to make this happen. Soumyadip built and sold his first startup in defence electronics by age 26, and has won 20+ International design awards for his product designs.

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 better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links from the Video

• Dr. Soumyadip Rakshit Linkedin: https://www.linkedin.com/in/soum