The EU IVDR is in place and we will focus on this episode on Class D devices. Andreas Stange will explain to us what TÜV SÜD learned from the 100th class D certificates they issued. We will also review the timeline for IVDR and explain the next deadline which is in October. So be aware of it now. 

Who is Andreas Stange? 

Dr. Andreas F. Stange is a vice president for the Medical and Health Services group at TÜV SÜD. Product Service. He serves as the global responsibility for the In-vitro Diagnostic Devices business line. Besides that, he is also overseeing TÜV SÜD`s Medical Health Services in North-East Asia. Dr. Stange joined TÜV SÜD in 2001 as a medical device expert and had various positions since then in the group. Before taking the current position in March 2017, he served as President & CEO of TÜV SÜD in Japan for eight years.

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link

Andreas Stange Linkedin Profile: https://www.linkedin.com/in/andreasstange/ 

TÜV SÜD Website: https://www.axonlawyers.com/ 

EU IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20230320 

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

The EU MDR is still not stable. There are still updates ongoing so stay tuned and listen to Erik Vollebregt explaining the Article 10a that will be integrated to the EU MDR where medical device manufacturers have to inform about interruption of supply. So what will be the requirements and what should you do. Listen to it to know more. 

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, 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 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 the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link

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

Axon Lawyers Website: https://www.axonlawyers.com/ 

EU MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20230320 

Medical devices: Council adopts new measures to help prevent shortages    https://data.consilium.europa.eu/doc/document/PE-54-2024-INIT/en/pdf 

Article Judith de Wildth – How to prepare for article 10a: https://www.linkedin.com/posts/erikvollebregt_how-to-prepare-for-article-10a-mdr-as-a-manufacturer-activity-7216378083308646401-vqzF 

EUDAMED roll-out timeline: https://health.ec.europa.eu/document/download/04ce2012-97df-4dd0-8a39-d4f6993b9e16_en?filename=md_eudamed_roadmap_en.pdf 

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

Registration of Medical Devices can be complicated. But here we will share with you the process for the United Arab Emirate where the famous city of Dubai is located. Ahmed Hendawy from Registitute is helping us to understand this process and he confirms that it is really simple. So no way that you miss this.  

Who is Ahmed Hendawy?

Ahmed is an esteemed leader in the field of healthcare consulting, renowned for his deep expertise in healthcare regulations, market access, and business strategy within the MENA region. As the founder and driving force behind Registitute, Ahmed has established the firm as a premier provider of specialized services in regulatory affairs and market access. With a distinguished career, including a previous role as the Head of Regulatory Affairs for the MENA region, Ahmed has demonstrated exceptional skill in navigating complex regulations and spearheading successful market entry strategies. Under his visionary guidance, Registitute has garnered a reputation for excellence and innovation in the healthcare consulting landscape. Registitute stands apart by delivering tailored solutions that address the unique challenges faced by healthcare organizations operating in the MENA region. Ahmed's strategic vision, combined with the expertise of the Registitute team, continues to drive positive change and support healthcare organizations in adapting to the ever-evolving healthcare landscape in the MENA region. In summary, Ahmed's leadership and Registitute's unwavering commitment to providing exceptional services position them as a trusted partner for healthcare organizations seeking regulatory expertise and market access support in the MENA region.

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Links from the Video

Ahmed Hendawy Linkedin : https://www.linkedin.com/in/ahmed-hendawy-a0a81511a

Registitute LinkedIn: https://www.linkedin.com/company/registitute/

Registitute Website : www.registitute.com

AL TIRYAQ LinkedIn : https://www.linkedin.com/company/al-tiryaq/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

More and more regulations have to be applied in parallel of the EU MDR and the one of the EU Battery Regulation is not an exception. Erik Vollebregt from Axon Lawyers will be explaining to us what are these additional requirements. He will also confirm that Notified Bodies can ask you questions about it and finally he will share some key timelines for its implementation. Spoiler Alert ! first is August 2024 so be quick. 

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, 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 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 the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Links from the Video

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

Axon Lawyers Website: https://www.axonlawyers.com/ 

EU Battery Regulation: https://data.consilium.europa.eu/doc/document/ST-10488-2023-INIT/en/pdf  

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

I am an EU pharma/device lawyer and problem solver. My practice focuses on European Union (EU) and national regulatory matters involving medical devices and pharmaceutical laws and guidelines. I am following very closely the new regulations on medical devices (MDR and IVDR), the GDPR and regularly advise clients in relation to the requirements applicable to their digital health technologies. I focus particularly on the different stages of the medical device CE marking process and advise on a wide variety of topics which include the following: - determination of the appropriate classification of individual products; - clinical investigation procedure (e.g. authorisation from the EU Member States competent authorities, opinion from Ethics Committee, amendment to the Protocol, informed consent, serious adverse event qualification and notification, handling of personal data); - drafting of clinical investigation and clinical trial agreements, distribution agreements and contract manufacturing agreements; -clinical data requirements and clinical evaluation; - conformity assessment procedure; - review of Instruction For Use, products' labelling and promotional material including websites; - post-marketing surveillance activities including the notification of adverse event, product recall or product withdrawal; - preparation and review of technical documentation; - reimbursement. I also advise on questions regarding marketing authorisation procedures, variation procedures, and clinical trials, promotional and marketing activities in the pharmaceutical sector. Specialties: Regulation of medical devices and medicinal products in the EU

 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

Fabien Roy Linkedin Profile: https://www.linkedin.com/in/fabien-roy-83b55021/

Company Website:   

Ai Act text: 

 Social Media to follow

 Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

 Twitter:

https://twitter.com/elazzouzim

 Pinterest: https://www.pinterest.com/easymedicaldevice

 Instagram: https://www.instagram.com/easymedicaldevice

Medboard

EU

Germany warns against overregulation of Medical Devices - Is it not too late: https://www.bundestag.de/presse/hib/kurzmeldungen-1006422

Title: MDR and IVDR next steps - Subtitle: Erik Vollebregt points: https://medicaldeviceslegal.com/2024/06/04/the-german-angle/

MDCG 2022-13 Rev1 - Extension of the scope of designations: https://health.ec.europa.eu/document/download/27f91dc2-b5bc-44f9-a975-5024ce3ea556_en?filename=mdcg_2022-13_en.pdf

MDCG 2024-10 Clinical Evaluation of orphan medical devices : For RARE DISEASES: https://health.ec.europa.eu/document/download/daa1fc59-9d2c-4e82-878e-d6fdf12ecd1a_en?filename=mdcg_2024-10_en.pdf

Scheer - Brain Stimuilators -: Risks associated with Brain Stimulators: https://health.ec.europa.eu/consultations/scheer-call-external-experts-scheer-wg-risks-health-associated-use-brain-stimulators-not-having_en

Fast access to Clinical Trial Information -: New CTIS: https://www.ema.europa.eu/en/news/faster-access-clinical-trial-information-europe

AI Supervision required - AI ACT: https://www.autoriteitpersoonsgegevens.nl/en/current/ap-and-rdi-supervision-of-ai-systems-requires-collaboration-and-must-be-arranged-quickly

UK

UK USA and Canada on AI - Guiding Principles: https://assets.publishing.service.gov.uk/media/66670b9be8d5f2d4bdfcbb37/transparency_ml-enabled_devices_guiding_principles.pdf

Swiss

SWISSDAMED Actors Module - Open in August 6th, 2024: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/release-notes.html

MEDTECH CONF

Medicall August 2nd 2024 - Chennai, India:  https://medtechconf.com/event/medicall-chennai-2024/

 RAPS Convergence Sept 17-19 2024 -  Long Beach, California, USA: https://medtechconf.com/event/raps-convergence-2024/

AI Act Summit October 1st 2024 - Strasbourg, France: https://medtechconf.com/event/ai-act-summit/

LIVE SESSION

Medical Device Live Expert #1 - Replay: https://www.youtube.com/watch?v=RrzXj36YrqcMedical Device Live Expert #2 - US is in the place: https://www.linkedin.com/events/medicaldeviceliveexpert-2-usais7214180765008359424/theater/

US

Essential Drug Delivery Outputs for Devices Guidance - Learn FDA requirements for EDDOs: https://www.fda.gov/media/179545/download

Recognized Standards - Change happens: https://www.govinfo.gov/content/pkg/FR-2024-06-24/pdf/2024-13777.pdf

US Webinar IVD classification -: July 16th 1pm EST: https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-in-vitro-diagnostic-product-ivd-classification-07162024

Blog post - The promise of AI in Health Care - FDA knows: https://www.fda.gov/medical-devices/digital-health-center-excellence/blog-promise-artificial-intelligence-holds-improving-health-care

Australia

Australia: Exempt Medical Device - They should still follow the rules: https://www.tga.gov.au/resources/resource/guidance/regulatory-obligation-exempt-medical-devices

Cosmetics or therapeutics -TGA helps you to decide: https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf

: Essential Principle Checklist -Template available: https://www.tga.gov.au/resources/resource/checklists/essential-principles-checklist

AusUDID is in the place - Australian UDI Database for sponsors and manufacturers: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/australian-udi-database-sponsors-and-manufacturers

Saudi Arabia

Extend Shelf Life - in case of Public emergency: https://tinyurl.com/EMDpod

Malaysia

Workshop Post-Market Requirements - July 16th, 2024: https://www.autoriteitpersoonsgegevens.nl/en/current/ap-and-rdi-supervision-of-ai-systems-requires-collaboration-and-must-be-arranged-quickly

Training: How to submit documents - July 17th, 2024: https://portal.mda.gov.my/index.php/doclink/program-8-hands-on-medcrest-post-market-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJwcm9ncmFtLTgtaGFuZHMtb24tbWVkY3Jlc3QtcG9zdC1tYXJrZXQtcGRmIiwiaWF0IjoxNzE4MjQ5OTgzLCJleHAiOjE3MTgzMzYzODN9._ZObFPlzSpQWnAoPKDxH_J8IWhmcTDNLsFpYe0AkO9M

Are you satisfied with Malaysia MDA - You can rate here: https://www.mda.gov.my/index.php/news/1418-kajian-kepuasan-pelanggan-mda-1-2024

South Africa

SAHPRA Medical Device Vigilance- Who to contact: https://www.sahpra.org.za/wp-content/uploads/2024/06/Contacts-for-Adverse-Events-Recalls-and-Market-Actions.pdf

PODCAST

Episode 288 - Cleaning Validation - How to select the worst case (Heena Thakkar): https://podcast.easymedicaldevice.com/288-2/

Episode 289 - AFNOR- How is a Notified Body designated: (Thomas Lommatzsch):  https://podcast.easymedicaldevice.com/289-2/

Episode 290 - How to submit your AI/ML SAMD the right way? (Richie Christian): https://podcast.easymedicaldevice.com/290-2/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

You don’t know what a regulator will say when seeing your AI/ML Software, then listen to this episode. Richie Christian will explain the important elements that you should take care off before to submit your dossier to your Notified Body or your Competent Authority. So enjoy.

Who is Richie Christian?

Richie Christian has more than 10 years of experience in medical device regulatory and quality. He has a Master’s degree in neurophysiology from the University of Auckland, and is passionate about digital transformation of the healthcare industry. Throughout his career, Richie has worked in numerous regulatory and quality roles with not only traditional hardware device manufacturers, but also cutting-edge AI/ML-enabled SaMD manufacturer.

In his most recent role as the Head of Regulatory and Quality, he spearheaded the development and implementation of a streamlined QMS, enabling them to achieve MDSAP certification and secure market authorisations for an innovative orthopaedics AI/ML-enabled SaMD in USA and Japan.

Richie relocated to Basel, Switzerland from New Zealand as a consultant for wega Informatik where he now applies his decade-long experience to help companies develop and deliver compliant medical device software. 

Who is Monir El Azzouzi?

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.

Links

·      Richie Christian Linkedin Profile: https://www.linkedin.com/in/christianrichie/

·      Wega Website:  https://www.wega-it.com/en/computer-systems-validation-quality-assurance#medical-device-compliance

·      AAMI/BS standard https://knowledge.bsigroup.com/products/application-of-iso-14971-to-machine-learning-in-artificial-intelligence-guide?version=standard

·      Good Machine Learning Practice for Medical Device Development: Guiding Principles: https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles

·      Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles https://www.fda.gov/medical-devices/software-medical-device-samd/transparency-machine-learning-enabled-medical-devices-guiding-principles

Social Media to follow

■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

■ Twitter:

https://twitter.com/elazzouzim

■ Pinterest: https://www.pinterest.com/easymedicaldevice

■ Instagram: https://www.instagram.com/easymedicaldevice

If you are looking for selling your medical devices in Europe, you will then maybe need a Notified Body unless your product is class I. In this episode, we talk with Thomas Lommatzsch about the process of designation and why it is so difficult. We will also cover some questions regarding the auditors, the costs, the audit by the competent authorities… So stay tuned. 

Who is Thomas Lommatzsch? 

Thomas LOMMATZSCH heads the Medical Business Unit of AFNOR Certification, which deals with the certification of medical devices within the notified body AFNOR Certification (NB0333). With over 20 years' experience within Notified Bodies under various European regulations, he has completed several notification projects, most recently the AFNOR Certification notification project under the MDR. Thomas is also involved in standardization work relating to the application of the AI Act, particularly with its application to medical devices. 

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link

Thomas Lommatzsch Linkedin Profile: https://www.linkedin.com/in/thomas-lommatzsch/ 

AFNOR webpage: https://certification.afnor.org/qualite/marquage-ce-dispositifs-medicaux 

EU MDR 2017/745: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20230320 

EU IVDR 2017/746: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20230320 

French competent authority ANSM: https://ansm.sante.fr/ 

JAT Joint Assessment: https://health.ec.europa.eu/document/download/b9d671f5-02d0-44b1-a207-b07aeb4ef931_en?filename=md_info_ja_mdr_en.pdf 

MDCG 2022-13 Designation, re-assessment and notification of conformity assessment  

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

Have you ever had to deal with Cleaning Validation. If yes than you know the pain to select the instruments and group them and for each group find a worst case. On this episode, we tell you how this should be working so you can guarantee to provide clean products and clean instructions to your customers. 

Who is Heena Thakkar? 

Heena Thakkar is a regulatory consultant currently working with Alceon Medtech Consulting. She is based in Gujarat, India. Heena is qualified in risk management, design controls, usability engineering, clinical evaluation, clinical trial management, quality management systems and process validation. She is also a certified internal auditor.  

Heena has around 8 years of experience in the field of regulatory affairs and quality management system for medical devices. She is experienced in regulatory submissions for vast range of devices ranging from orthopaedic devices, endovascular devices, single-use consumables, ophthalmic devices and wound care devices. She also conducts external trainings in the areas such as risk management, quality management system, EU MDR and EU IVDR.  

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link: 

Heena Thakkar Linkedin Profile:  

https://www.linkedin.com/in/heenathakkar?utm_source=share&utm_campaign=share_via&utm_content=profile&utm_medium=ios_appAlceon Medtech Consulting Website:  

https://alceonconsulting.com

List of standards helpful for cleaning validation of reusable instruments  

ANSI/ AAMI ST98: Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices https://www.aami.org/standards/featured-standards/aami-st98  

USFDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (https://www.fda.gov/media/80265/download) 

ISO 17664-1:2021: Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (https://www.iso.org/standard/81720.html) 

ISO 15883-1:2006: Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (https://www.iso.org/standard/41076.html) 

ISO 15883-5:2021: Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (https://www.iso.org/standard/68297.html) 

ASTM F3208-20: Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices (https://www.astm.org/f3208-20.html) 

ASTM F3293-18: Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices (https://www.astm.org/f3293-18.html) 

There are many additional standards that manufacturers will need to refer to in addition to the ones listed above. Contact us at [email protected] for additional information or service inquiry. Thank you!  

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

EUROPEEU MDR 26 May 2024 - Was there any apocalypse:

France: https://ansm.sante.fr/actualites/reglement-europeen-relatif-aux-dispositifs-medicaux-fin-de-la-periode-de-transition

Netherland: https://www.igj.nl/zorgsectoren/medische-technologie/nieuws/2024/05/23/fabrikanten-van-medische-hulpmiddelen-moeten-uiterlijk-26-mei-een-aanvraag-hebben-ingediend-voor-ce-certificering

EU shortage managed - EUDAMED and IVD extension also discussed: https://www.consilium.europa.eu/en/press/press-releases/2024/05/30/medical-devices-council-adopts-new-measures-to-help-prevent-shortages/?utm_source=brevo&utm_campaign=AUTOMATED%20-%20Alert%20-%20Newsletter&utm_medium=email&utm_id=320

EMA Q&A on Combination products - Do you need a Notified Body? https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf

EU talks about SoHo -: Substances of Human Origin

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:PE_8_2024_INIT&qid=1716536451356

https://www.consilium.europa.eu/en/press/press-releases/2024/05/27/council-adopts-new-rules-on-substances-of-human-origin/

Italy Database error - Updating expired (AI)MDD certificates https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6569

Ireland guide on In-House IVDs - Laboratories to listen: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/guide-for-health-institutions-who-manufacture-and-use-in-house-ivds-in-ireland-v1.pdf?sfvrsn=8

Combined Studies in the EU - COMBINE PROJECT:

https://ec.europa.eu/newsroom/sante/items/830485/en

https://health.ec.europa.eu/document/download/77e1409a-f4c0-45db-bff1-4873c7a0e7ae_en?filename=md_combined-analysis-phase-report.pdf

Notified Bodies

Survey Result: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf

Team-NB Survey: https://www.team-nb.org/wp-content/uploads/2024/05/Team-NB-MD-Sector-Survey-PressRelease-20240515.pdf

New Notified Bodies for EU MDR –

MTIC InterCert Italy: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?organizationRefeCd=EPOS_43390&filter=notificationStatusId:1

Kiwa Istanbul: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1007731?organizationVersion=18

QMS Services GmbH Austria: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1007832?organizationVersion=1

UKUK on international recognition - Approve products without CE or UKCA mark: 

https://www.gov.uk/government/news/mhra-announces-a-proposed-framework-for-international-recognition-of-medical-devices

https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/statement-of-policy-intent-international-recognition-of-medical-devices

UK implementation of Future Regulation - When will this come in force: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations

UK Common Specifications for IVD - Provide your opinion: https://www.gov.uk/government/consultations/common-specification-requirements-for-in-vitro-diagnostic-devices

UK suspected counterfeit Medical Device -  How to report: https://www.gov.uk/government/publications/report-a-non-compliant-medical-device-enforcement-process/report-a-non-compliant-or-suspected-counterfeit-medical-device

UK Ai Airlock - Be ready to help the government: https://www.gov.uk/government/news/mhra-launches-ai-airlock-to-address-challenges-for-regulating-medical-devices-that-use-artificial-intelligence

Webinar planned July 23rd: https://www.eventbrite.co.uk/e/ai-airlock-the-regulatory-sandbox-for-aiamd-in-healthcare-webinar-tickets-896407919217

Easy Medical Device: eQMS SmartEye

Video: One of the best eQMS for Medical Devices  One of the best eQMS for Medical Devices

Events:Medtech Conf:

Title: International Medical Device Exhibition and Conference - Subtitle: Malaysia 10th to 12th December 2024 : https://medtechconf.com/event/imdec-2024-exhibition-conference/

Training

Green Belt Training for EU MDR 2017/745 24th-28th June 2024: https://school.easymedicaldevice.com/gb/

EU Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/

Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/

WORLDUSUS Remanufacturing or Servicing  - Webinar replay included:

https://www.fda.gov/media/150141/download

Webinar: https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-final-guidance-remanufacturing-medical-devices-06272024

US - Use of Patient Generated Data - Medical Device Development: https://www.fda.gov/medical-devices/medical-devices-news-and-events/co-sponsored-public-workshop-using-patient-generated-health-data-medical-device-development-case

US Laboratory Developed Tests - Final rules defined and Webinar to explain:

https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-final-rule-medical-devices-laboratory-developed-tests-05142024

https://www.fda.gov/medical-devices/laboratory-developed-tests/laboratory-developed-tests-frequently-asked-questions

https://www.fda.gov/news-events/press-announcements/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests

Australia

Australia - in-house IVDs requirements - Support Australian Laboratories: https://www.tga.gov.au/resources/resource/guidance/regulatory-requirements-house-ivds

Australia on boundary and Combination products List: https://www.tga.gov.au/sites/default/files/2024-05/examples-boundary-combination-products-and-product-category.pdf

Saudi Arabia

Saudi Arabia - Webinar Biological Evaluation - 6 June 2024 10am Saudi Time https://www.sfda.gov.sa/en/workshop/716404

NigeriaGuidance to register Medical Devices - Registration, labelling and advertising:

https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Registration-Regulations-2024.pdf

https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Labelling-Regulations-2024.pdf

https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Advertisement-Regulations-2024.pdf

India

CDSCO laboratory testing - But in the Country and not outside: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTEzMTg=

Malaysia

Malaysia Guidance for Medical Device - Change Notification support: https://www.mda.gov.my/index.php/announcement/1401-public-comment-draft-guidance-document-change-notification-for-registered-medical-device

Hong-Kong

Overview of a Local Responsible Person - Who? What? When? Where?: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-01-E.pdf

Singapore

 Singapore Cybersecurity labelling- SAt which level is your product: https://www.csa.gov.sg/our-programmes/certification-and-labelling-schemes/cls-md

PODCASTPodcast Nostalgia - What topics were discussed

Episode 283: Quality Field Service for Medical Devices with Michael Israel: https://podcast.easymedicaldevice.com/283-2/

Episode 284: How to select and evaluate your Contract Manufacturer with Keith Smith: https://podcast.easymedicaldevice.com/284-2/

Episode 285: Are you Correction or Corrective Action or Preventive Action with Vincent Cafiso: https://podcast.easymedicaldevice.com/285-2/

Episode 286: Summative Evaluation - Common Mistakes with Amandine Broussier: https://podcast.easymedicaldevice.com/286-2/