Why Should You Attend:
There have been several ongoing changes adopted by the FDA, EU, ISO 13485, Medical Device Audits, and related to medical devices in just the last few years. And in order to understand these changes and adhere to all these regulatory changes is advantageous to all medical device manufacturers involved in the manufacture of class II and class III devices.
The European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) came into effect as of May 26th, 2017. The clock is ticking for current Medical Device manufacturers in the European marketplace to develop and implement strategies to be fully compliant.
Manufacturers of currently approved in vitro diagnostic medical devices will have a transition time of five years, up to 26 May 2022 to meet the requirements of the IVDR. Products already certified by a Notified Body may be placed on the market for further 2 years under some conditions, e.g. the certificate issued under the IVDD is still valid and subject to surveillance by the Notified Body who had issued it and no significant changes to the product are made.
What are the key changes expected in the new IVDR? The actual terms of the proposed regulation are subject to change until final publication of the IVDR in the Official Journal of the European Union. Some of the key changes expected include:
The new In Vitro Diagnostic Regulation (IVDR) is complex and the changes it embodies are significant. Our white paper serves as a first step for medical device manufacturers in the EU Market to better understand the immediate IVDR implications by:
Areas Covered in the Webinar:
Who Will Benefit:
Dr. George Yanulis has consulted in Medical Device Product Development and Research for 20 years and has a Doctorate and Master’s Degree in Biomedical Engineering. He has conducted cardiovascular device research at the Cleveland Clinic Foundation on cardiac pacing paradigms used in heart failure patients. In addition, Dr. Yanulis has been involved in the R&D Medical Device Consulting & Litigation Support as an Expert Witness for over 10 years and has been involved in numerous medical device liability and patent infringement cases. He provides expertise to attorneys, medical device companies, health care systems and insurance carriers related to FDA medical device controls, PMAs, post-market surveillance issues, medical device/product failures and IP medical device issues. In addition, he has reviewed MDR(s) and other adverse events related to implant device failure. Dr. Yanulis is highly motivated in maintaining and providing the highest level of quality in the design, development and safe and effective use of all types of cardiac device implants.
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