16th July 2019, 9AM - 6PM
16th July 2019, 9AM - 6PM
Date: 16th July 2019,Tuesday
Time: 9AM – 6PM
Venue: TÜV SÜD PSB, 1 Science Park Drive, Singapore 118221
Fees: S$650/pax (Excl. GST)
The European Union’s Regulation on IVD medical devices 2017/746 (IVDR) came into force on 25 May 2017 and is currently in implementation. It will replace Directive 98/79/EC on IVD medical devices (IVDD) after a five years transition period in May 2022.
Manufacturers of new IVD devices and devices currently approved under IVDD will have to comply to IVDR from May 2022 onwards. This means they must absolve a new conformity assessment procedure regarding their quality system and their devices, to CE-mark their devices and place them on the EU market. For products currently certified by a notified body - provided certain conditions are met - the transition period may be extended until 26 May 2024,.
New or stricter requirements of the IVDR will have a significant impact on manufacturers and all other stakeholders and will result in reasonable challenges. Changes affect areas such as classification of IVD devices, conformity assessment procedures, clinical evidence, post market surveillance, distribution line and registration. The biggest impact results from the new classification scheme: the percentage of products requiring a conformity assessment under participation of a notified body will change from less than 20% under IVDD to more than 80% under IVDR.
This seminar will provide you insights into the key regulatory changes of the IVDR, to help you to prepare your organisation and your devices for IVDR compliance.
Topics covered in the course:
This seminar is specially designed for:
DR. DIETER SCHÖNWALD & DR. LAURA SCRIVANO
Dr. Dieter Schönwald is the Senior Manager International Affairs (IVD) and Global Technical Officer IVD at TÜV SÜD Product Service GmbH, Medical Health Services, München. His major task is to make preparation for TÜV SÜD to become a notified body under the IVDR. Dieter has been working for about 20 years at notified bodies in different functions, e.g. as auditor, product specialist, head of certification body, head of IVD department. after several years in pharmaceutical, medical device and in-vitro diagnostic industry in design and quality assurance. He holds a PhD in the field of Immunology and Immunogenetics.
Dr. Laura Scrivano is the Product Specialist and Lead-Auditor at the Department In-Vitro Diagnostics at the TÜV SÜD Product Service GmbH, Medical Health Services, München. Laura holds a PhD in the field of Molecular Biology with a focus on Molecular Virology and Immunology. After her PhD, she was working in a diagnostic laboratory for several years as a medical virologist. In 2015 she joined to TÜV SÜD Product Service GmbH and her major tasks are Conformity Assessments according to the IVD Directive for all the currently List A products, several List-B devices and Self-testing devices. She is also working as a Lead-Auditor (including MDSAP) for manufacturer of IVDs.
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