I am currently completing a Master of Science degree in Quality at the Institute of Technology, Sligo (Atlantic Technical University).
 
As part of my thesis, I would like to request your participation in a short survey titled:
 
"What amendments can be made to the European Union Medical Device Regulation 2017/745 to address the concerns of Class III medical device manufacturers?"
This survey has 9 question topics and will take no more than 15 minutes to complete.
 
The purpose of this survey is to gather information regarding the concerns of manufacturers across Europe in relation to EU MDR 2017/745 and to subsequently obtain input on the amendments that could potentially be made to the regulation to address such concerns.
 
The analysis of this survey will form part of the results and discussion section of the dissertation.
 
The implication of this study will be to present a formal, extensive study to the European Commission services in charge of medical devices to facilitate discussions on possible amendments or corrigenda to EU regulation on medical devices.
 
Your participation in this survey is completely voluntary and your responses are anonymous and confidential. There are no means of linking your input, to you, as a participant of this survey.
You will not be asked for your email address or any contact details to participate in this survey. However, an option will be available to submit your email address should you wish to participate in a follow-up activity.
To read about the data protection and privacy of the survey software used to collect this data, please visit https://cloud.google.com/privacy/gdpr
You can withdraw or opt-out at any point in the process by pressing 'Clear form' on the bottom-right of the form. Your responses completed up to that point will be cleared. Participants should then close the window to terminate the process.
 
If you have any questions about this survey, difficulty accessing the site or completing the survey, wish to fill out a hardcopy of this survey, or wish to provide further feedback, please contact me at ‘shauna.coen@mail.itsligo.ie’.
 
Thank you in advance for taking the time to complete this survey, your feedback is greatly appreciated.