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The European Commission published proposals for new regulations of medical devices and in vitro diagnostics in 2012. Now, after years of negotiation within the EU legislative system and with interested stakeholders, the new regulations are expected to be published in 2017. This four-week virtual program draws together industry experts and leading Notified Bodies who have been closely following the evolution of the proposed regulations, anticipating the final texts, developing positions on what will be required by the regulations, and understanding the impact on manufacturers, devices and systems both new and legacy.
Uniquely, each week provides different perspectives/opinions from different Notified Bodies and experts on the key significant changes that will impact all medical devices and in vitro diagnostics being placed into Europe under the new European Medical Device Regulation (MDR) and the In VitroDiagnostics Regulation (IVDR). This program will also consider the impact on legacy devices cleared, CE marked, and under the existing EU Medical Device Directive (MDD) and In Vitro Diagnostics Directive (IVDD).
Theresa Jeary has over 25 years’ experience in the medical device and pharmaceutical industries as well as Notified Bodies. She is currently responsible for managing the team of product experts and is a Certificate decision maker at LRQA. A well-known expert within the device and drug product arena, Theresa is a regular speaker at international regulatory conferences and seminars.
Theresa’s background includes the development and commercialization of woundcare devices utilizing animal tissue as well as various devices across a broad scope incorporating ancillary medicinal substances. Theresa also has extensive Quality Management System expertise, including maintaining ISO 13485 certification and Good Manufacturing Practice for medicinal products. Theresa holds a Master’s Degree in Pharmaceutical Science from the Royal College of Surgeons, Ireland, and is eligible to be a Pharmaceutical Qualified Person. She is an active member of The Organization for Professionals in Regulatory Affairs (TOPRA) SPIN Committee for Medtech, and regular contributor to Regulatory Rapporteur magazine.
Martin Penver leads LRQA’s medical devices team as Head of Notified Body. Martin has 16 years of experience within the medical device industry, and is also a trained ISO 13485 lead auditor Prior to joining LRQA as Operations & Technical Manager in 2012, Martin spent six years at other Notified Bodies. Martin’s background includes product expertise on vascular therapies where he has been responsible for evaluating and assessing technical documentation, and shape memory alloy processing involving the development and manufacturing of stent positioning systems for renal and coronary arteries.