The European Union’s new Medical Devices Regulation (MDR), which replaces a decades-old legislation, will require manufacturers to make significant changes in product development, data reporting and their quality management system.
As a result, device manufacturers can expect higher costs and longer timelines for developing new products, as well as costly new clinical monitoring and evidence generation to recertify many existing products, deeply affecting business models of all medical and diagnostic device companies.
Within our webinar we will provide you with a clear and comprehensive picture about the main changes and challenges faced by manufacturers under the new EU regulations, and how our services will ensure an early compliance which can lead optimal progress of your product development and CE certification.
The webinar will give you details about the most important changes in the MDR:
- Transition period from MDD to MDR – timelines and due dates
- Reclassification of certain devices – new challenges
- New requirements for Technical Documentation
- Clinical testing requirements – sources of Clinical Data for CE Marking
- The mandatory Post-Market Clinical Follow-up
We will provide details about how HungaroTrial can help you to find the appropriate transition path from MDD to MDR by providing services for planning, managing and reporting clinical trials as well as consultation support in defining, managing and performing the conformity assessment process leading to obtaining the CE mark for your product within the shortest realistic timeframe.
The webinar will be followed by a Q&A session for you to get direct feedback on key areas of uncertainty. Book your place today.
Presented by
Antal Solyom,
Director of Medical Device Unit
Professional background
17+ years in Certification of Medical Devices
2018 – Director of Medical Device Unit, HungaroTrial
2016 – 2017 Head of Certification Office in Medical Division, TÃœV Rheinland Intercert
2010 – 2017 Certifier in Medical Division, TÃœV Rheinland Intercert
2009 – 2017 Lead auditor in Medical Division, TÃœV Rheinland Intercert
2007 – 2009 Lead auditor in Medical Division, TÃœV Rheinland of North America (Boston office)
2004 –2007 Lead auditor, Business Field Manager, TÃœV Rheinland Intercert, Budapest
2001 – 2003 Lead Auditor, Non-active Medical Department and Head of Mechanical Laboratory – Test engineer, Institute for Medical and Technical Engineering ORKI, Budapest
1998 – 2001 QMS Manager, Head of QC, Metaltrade-Miskolc Kft., Miskolc
Éva Reif,MD,
Clinical Research Manager
2011 – Clinical Research Manager at HungaroTrial
1998 – 2011 Clinical Research Associate, later Clinical Project Leader at Bristol Myers Squibb and Sanofi – Aventis
1988 – 1998 Medical practice in Intensive Care Unit and Anesthesiology
(Cardiology Intensive care, General Anesthesiology practice, Cardiac- and Vascular Surgery)
1988 Semmelweis Medical University, Budapest, Hungary
Graduated as Medical Doctor
