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EU IVDR & MDR Forum

2019 GMED North America Forum

Calling on Medical Device enthusiasts of the European Regulatory framework (RA/QA professionals, Medical Device Experts, Auditors and Manufacturers)

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GMED F 2019 FROSTY

About the training

We are happy to announce our Annual GMED North America Forum. Meet us for a day of Regulatory and Technical updates and information. We have created an exciting program with a strong emphasis on the new (EU) Regulations 2017/745 for Medical Devices and 2017/746 for In- Vitro Diagnostic Devices. The forum format will feature presentations by our GMED national and international regulatory experts with facilitated workshops.

Check out the Program

Agenda

Meet the Speakers

Dr. Amelia Kara

Clinical Data Evaluator

The Clinical evaluation under the aegis of the new regulation 2017/745

It is undeniable that the clinical evaluation takes the lion's share of novelties in the European Regulation (EU) 2017/745. The criteria of equivalence are much more restrictive which will lead to an explosion of the number of clinical investigations in the coming years. Post-Market clinical follow-up is not left out with the appearance of PSUR, SSCP, Eudamed database... etc.. The landscape of the medical device is about to change drastically. Take part in our workshop and learn how to navigate clinical evaluations under the MDR. Case studies will be provided to ensure maximum understanding of expectations regarding clinical evaluation reports.
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Sebastien Rosset

Certification Project Manager / Lead Auditor

Applicable standards for active medical devices for CE marking

This topic will help you to appropriately take into account the standards applicable to your product in order to identify in advance the key success factors to exporting your medical device in Europe. This topic will cover the list of harmonized standards in Europe, and provide useful information on how to prepare your dossier before carrying out the tests.
Read bio

Florianne Torset- Bonfillou

Regulatory, Education and Quality - Lead Auditor

Article 120 & 110 Implementation: Transition to EU Regulations 2017/745 (MDR) & 2017/746 (IVDR)

The entry into force of the MD and IVD Regulations took place on May the 25th, 2017, with a transition period of 3 years for the Medical Devices including Active Implantable Medical Devices; and 5 years for In Vitro Diagnostic Medical Devices. From their application date, respectively 2020 for the Medical Device Regulation and 2022 for the In Vitro Diagnostic Regulation. Certificates issued during the transitional period will have a validity period which cannot exceed 2024, irrespective of the Directive or conformity assessment procedure claimed by the manufacturer. Article 120 of the Medical Devices Regulation and Article 110 of the In Vitro Diagnostic Regulation describe each of the transitional provisions applicable. This presentation will focus on the key elements to be considered by MD & IVD Manufacturers to successfully navigate through the transition.

Dr. Amani Bentson

Certification Project Manager

Person Responsible for Regulatory Compliance (PRRC)

Articles 11 to 16 of the EU MDR 2017/745 are bringing brand new sets of requirements related to stakeholders other than the manufacturer, involved in the Medical Device lifecycle. The stakeholders themselves are not new but their responsibilities are now part of the Regulation. During this workshop, you will have the opportunity to work on and discuss with your peers about the new requirements related to economic operators and to the person responsible for regulatory compliance. Key requirements will be reviewed with discussion on implementation.
Dr. Amelia Kara photo

Dr. Amelia Kara

Clinical Data Evaluator

The Clinical evaluation under the aegis of the new regulation 2017/745

It is undeniable that the clinical evaluation takes the lion's share of novelties in the European Regulation (EU) 2017/745. The criteria of equivalence are much more restrictive which will lead to an explosion of the number of clinical investigations in the coming years. Post-Market clinical follow-up is not left out with the appearance of PSUR, SSCP, Eudamed database... etc.. The landscape of the medical device is about to change drastically. Take part in our workshop and learn how to navigate clinical evaluations under the MDR. Case studies will be provided to ensure maximum understanding of expectations regarding clinical evaluation reports.

Amelia Kara is a Doctor of Medicine, Specialist in Cardiology and obtained an Inter-University Degree of Investigator in Clinical Research from the University PARIS 7. Prior to joining the GMED NA team, Amelia practiced several years in Hospital Specialized in Cardiac Surgery and then 4 years at LNE-GMED as Evaluator and Project Manager in the Certification of Implantable Medical Devices. At GMED NA, Amelia is the Internal Physician in charge of the evaluation of Clinical data and perform RTAs in connection with the clinical strategy.

Sebastien Rosset photo

Sebastien Rosset

Certification Project Manager / Lead Auditor

Applicable standards for active medical devices for CE marking

This topic will help you to appropriately take into account the standards applicable to your product in order to identify in advance the key success factors to exporting your medical device in Europe. This topic will cover the list of harmonized standards in Europe, and provide useful information on how to prepare your dossier before carrying out the tests.

Sebastien Rosset is a Certification Project Manager and Lead Auditor at GMED North America. He received an Engineering degree specializing in measurement and automation from INSA CVL (France) and a master’s degree in electronics from the University of Montpellier II in France. Prior to joining GMED North America. , Sebastien worked as a test engineer and technical manager in the Medical Device Industry in the French National Laboratory (LNE, the parent company of GMED North America. ). Sebastien has been working since 2011 on performing tests on active medical devices, following the standards IEC 60601, 62366, 62304. At GMED North America., Sebastien is a Lead Auditor specialized in active medical devices and software.

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