Why Should You Attend:
In the wake of well publicized issues in the regulation of medical devices in Europe, including metal- on-metal hip failures and the PIP breast implant scandal, the new European Medical Device Regulation was published in May of 2017. The new regulation expands the definitions of controls within the market for manufacturers, Importers, distributors and authorized representatives as well as applying stringent new controls to Notified Bodies. The impacts of these changes can already be felt throughout the industry.
The Medical Devices Regulations are due for significant update with areas such as Post Market Surveillance and Economic Operators being major areas of change. The final form of the regulations is now set and due to be voted into European Law. The new regulations need to be considered now at all organizational levels as they will be impacting on decisions taken today.
This webinar is designed for business leaders with executive responsibilities. This course quickly identifies the areas of strategic impact, possible costs and the time lines associated with the new EU Medical Device Regulations. The main impact areas are identified and discussed with possible approaches and budget and timeline considerations. Get ahead of the curve and ensure you organization has a solid basis for managing this transition and ensuring that key products have continued market access in the EU.
Areas Covered in the Webinar:
Review of the structure of the new regulation
Overview of impact areas of regulatory change
Details examination of :
Product Classification
Clinical data PMS and PMCF/clinical evaluation reports
Transition arrangements
Technical documentation requirements
Unique device identification
Economic operators
Technical data including risk management
In the wake of well publicized issues in the regulation of medical devices in Europe, including metal- on-metal hip failures and the PIP breast implant scandal, the new European Medical Device Regulation was published in May of 2017. The new regulation expands the definitions of controls within the market for manufacturers, Importers, distributors and authorized representatives as well as applying stringent new controls to Notified Bodies. The impacts of these changes can already be felt throughout the industry.
The Medical Devices Regulations are due for significant update with areas such as Post Market Surveillance and Economic Operators being major areas of change. The final form of the regulations is now set and due to be voted into European Law. The new regulations need to be considered now at all organizational levels as they will be impacting on decisions taken today.
This webinar is designed for business leaders with executive responsibilities. This course quickly identifies the areas of strategic impact, possible costs and the time lines associated with the new EU Medical Device Regulations. The main impact areas are identified and discussed with possible approaches and budget and timeline considerations. Get ahead of the curve and ensure you organization has a solid basis for managing this transition and ensuring that key products have continued market access in the EU.
Areas Covered in the Webinar:
Review of the structure of the new regulation
Overview of impact areas of regulatory change
Details examination of :
Product Classification
Clinical data PMS and PMCF/clinical evaluation reports
Transition arrangements
Technical documentation requirements
Unique device identification
Economic operators
Technical data including risk management
Speakers
Richard Young (BSc (Hon) MSc, AIQA, ) Managing Director of Acclaim Biomedical Consulting Ltd, has worked in the Medical Device and In Vitro Diagnostic markets for over 25 years with a personal focus on regulatory compliance, process validation and risk management.Richard has been an active member of many groups through his time in industry, including representing industry in the formation of the “beyond compliance initiative” and spending many years on the Eucomed Standards Focus Group as well as standards groups such as LBI 35.
Over the last few years, his consulting activities have included a large proportion of training and education including teaching at Sheffield Hallam University in the UK on a Post Graduate Diploma Course.
