Meeting the In Vitro Medical Devices Regulation MasterClass
Online MasterClass | 11-13 October, 2021
The In vitro Medical Devices Directive has been the route to CE marking of in vitro medical devices in Europe since 2002. In 2017 the new In Vitro Medical Devices Regulation (IVDR) was published and comes into force in May 2022. From this moment all IVDs must comply with the new IVDR. At the moment around 20% of IVDs require notified body intervention prior to be being placed on the market, under the new regulation this will increase to around 85%. The new regulation has many more requirements than the current directive and whilst most are not going to prove ‘difficult ‘ to implement, there is much to do in the time left available. The aim of this event is to provide all those involved with IVDs a broad overview of the IVDR with practical guidance to navigating the additions and expectations of the law.
Meeting the In Vitro Medical Devices Regulation MasterClass
Online MasterClass | 11-13 October, 2021
EVENT INTRODUCTION
The In vitro Medical Devices Directive has been the route to CE marking of in vitro medical devices in Europe since 2002. In 2017 the new In Vitro Medical Devices Regulation (IVDR) was published and comes into force in May 2022. From this moment all IVDs must comply with the new IVDR. At the moment around 20% of IVDs require notified body intervention prior to be being placed on the market, under the new regulation this will increase to around 85%. The new regulation has many more requirements than the current directive and whilst most are not going to prove ‘difficult ‘ to implement, there is much to do in the time left available. The aim of this event is to provide all those involved with IVDs a broad overview of the IVDR with practical guidance to navigating the additions and expectations of the law.
• IVD Regulatory Affairs managers • IVD Quality Managers • IVD Quality Engineers • Manufacturers of IVDs for the EU • Designers of IVDs for the EU • Anyone tasked with IVDR implementation
Past Clients
Testimonials
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The level of professionalism of the trainer. Fine-tuned program without wasting time
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Managing Director – European pharma company
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Clear and interesting way of presenting issues, good examples and very knowledgeable trainer.
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HR Director - Multinational company based in Europe
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Excellent trainer, super skilled, funny and extremely dynamic
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M&A Professional
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This training was interesting and I would love to attend more trainings like this.
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HR Professional
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All lectures of the trainer was exactly what I was looking for and it was directly related to my experties and area that I am working. On top of that he prepared all lectures in a very practical way and also took his time to asnwers to the questions and he made sure that we got the asnwer. The organization of this class was also very good.
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Pharmaceutical professional
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Comprehensive overview with very knowledgeable and experienced trainers. The break-out sessions were great as they made the course more interactive and allowed us to apply the concepts in practice.
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Banking professional from Europe
About GLC EUROPE
Global Leading Conferences is specialized in designing, creating and executing impactful, and pragmatic Conferences, Masterclasses and in-house training.
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Specialized in planning, designing, and organizing interactive, impactful, and pragmatic B2B events, GLC actively collaborates with professionals in major sectors, such as Finance, Pharmaceutical, Human Resources, Health & Safety, and Energy to understand the challenges and issues that each industry endures.
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The MANAGEMENT
GHAZAL ZOHREHNEJAD
Managing Director / Co-founder
LÁSZLÓ ÁRVAI
Managing Director / Co-founder
KRISZTIÁN ÖTVÖS
Managing Director / Co-founder
