https://www.youtube.com/embed/aGc9pXaYTeU?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

We talked a lot about the EU MDR and the difficulty for some manufacturers to transition to this new legislation. But today we will explain why IVDR manufacturers will struggle more. I will explain to you the change in terms of product classification within the IVDR 2017/746. Because of this, a lot of manufacturers that didn’t need a Notified Body before will need one now. And as you may know, as of today, the number of Notified Bodies is not really high. So I hope this episode will help you understand the situation for the IVD business as there is a risk for manufacturers but also for patients.

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, Podcast, Online courses…

• Notified Bodies IVR Codes: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R2185&from=EL

The post Will it be really difficult for IVD manufacturers? [IVDR 2017/746] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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

This podcast episode is following a presentation I have made during the Greenlight Guru Summit on EU MDR and IVDR. I have explained how to create a label that fulfills the requirements of the EU MDR. I have placed on the show notes the link to it. After the session, I have received a lot of questions and I didn’t have the time to answer all of them, so I said to myself that maybe it would be better to have 1 podcast episode instead of me answer per email to each person. I am sure that the question people asked is common to other persons so let’s review that together.

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…

• Medtech Europe: https://www.medtecheurope.org/resource-library/use-of-symbols-to-indicate-compliance-with-the-mdr/

The post How to create a Label under MDR? (Questions & Answers) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

https://www.youtube.com/embed/HoqcVBAr960?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Let’s discuss System and Procedure Pack. We usually talk about medical devices like as an object that is used in the healthcare industry. But when you have to combine multiple objects, how can you then regulate that. Is there one classification for all or should you classify and register each of them. And what if all these objects are already CE marked?

So this episode will try to help you understand the legislation for these types of products described in article 22 of the EU MDR 2017/745 regulation on system and procedure pack. We will also mention the KITS that are described in the EU IVDR 2017/746 to show if there is an equivalent for in-vitro diagnostics

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 has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

He proposes also the service of the UK Responsible Person and EU Representative. If you need any support for your Quality and Regulatory Affairs activities, don’t hesitate to contact him.

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

The post How System and Procedure Pack are regulated under EU MDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

https://www.youtube.com/embed/k3gY8mDpGj4?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

With the EU MDR 2017/745 and IVDR 2017/746 the role of Economic Operators is becoming clearer. In the case you are located outside of Europe and you need to import your Medical Devices in the EU, you need to have an Importer.

In this episode we will talk of the importer role and what they need to check before your product is placed on the EU market.

And then we will explain the model of Independent Importer which is an entity that is not touching your products but they are still liable for any product on the Market.

This is what Edgar Kasteel from MedEnvoy will try to explain to us.

Edgar is an international business development expert and has many years of experience supporting European, American and Asian manufacturers of medical devices and IVDs in establishing or expanding their business across the globe.

Luctor Medical focuses on market entry from a commercial point of view. MedEnvoy assists manufacturers to meet the Importer obligations related to the upcoming MDR and IVDR.

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

• Edgar Kasteel LinkedIn Profile: https://www.linkedin.com/in/edgar-kasteel-0551b71/

The post How to import your Medical Devices with an Independent Importer? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

https://www.youtube.com/embed/PSk7JtreZvg?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

This month we will review what happened within the Medical Device Industry and there was some updates.

Here is the agenda:

• EUDAMED

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, Podcast, Online courses…

EUDAMED

• EU Commission EUDAMED Legacy devices: https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/legacy_dvc_management_en.pdf

COVID 19 Section

• TEAM-NB position paper – Commission Notice 2021/C 8/01: https://www.team-nb.org/it-appears-that-there-are-differences-in-the-approach-between-member-states-and-national-competent-authorities-concerning-the-implementation-the-commission-notice-2021-c-8-01-on-remote-audits-under-th/

• Survey result: https://www.linkedin.com/posts/melazzouzi_medicaldevices-easymedicaldevice-regulatoryaffairs-activity-6761649059909419009-h5u2/

• COVID-19 tests: https://ec.europa.eu/health/sites/health/files/md_sector/docs/covid-19_ivd-qa_en.pdf

• Clinical Trials during Covid-19: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf

OTHER

• Norwegian: https://legemiddelverket.no/Documents/Medisinsk%20utstyr/Spr%C3%A5kkrav/Language%20requirement.pdf

• MHRA Virtual manufacturer Version 3 including elements about Brexit rules:  https://www.gov.uk/government/publications/medical-devices-virtual-manufacturing-replaces-own-brand-labelling/virtual-manufacturing-of-medical-devices

WORLD

• Australia:
  • Consultation on Nanoparticles: https://consultations.health.gov.au/tga/medical-devices-nanomaterials/

TOOL

• Easy Medical Expert http://easymedicalexpert.com

Notified Body

• Instituto Superior di Sanita. https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=311094&version_no=3

Events

• Virtual Summit Greenlight Guru: March 17th – How to create labels per EU MDR? https://www.linkedin.com/events/eumdr-ivdrtruequalitysummitseri6766032051045986304/

Podcast episodes

• Podcast Episode 114 – What is the QA RA Mindset with Michelle Lott from Lean RAQA https://podcast.easymedicaldevice.com/114/

Telegram group:  https://t.me/easymedicaldevice

The post What is the Medical Device News? [March 2021 update] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi