Regulation (EU) 745/2017 on Medical Devices (MDR) and Regulation (EU) 746/2017 on In Vitro Diagnostic Medical Devices (IVDR) require manufacturers of Medical Devices and Authorised Representatives of Medical Devices and In Vitro Diagnostic Medical Devices to have a person responsible for regulatory compliance.
The Person Responsible for Compliance must have either a university degree in medicine, law, pharmacy, engineering or other relevant scientific discipline and at least one year of experience in regulatory affairs or quality management systems related to medical devices, or four years of experience in regulatory affairs or quality management systems related to medical devices.
Manufacturers of custom-made medical devices may demonstrate the expertise of the Person Responsible for Compliance by providing evidence of at least two years of professional experience in a relevant field of manufacturing.
The Person Responsible for Regulatory Compliance should at least ensure that before releasing a product, compliance is checked through the Quality Management System, that the technical documentation and the EU Declaration of Conformity have been prepared and are up to date, that post-marketing obligations, notification obligations, etc. are fulfilled.
Both regulations allow small and micro enterprises to outsource this service.
The EUDAMED database will reflect who performs these functions in each medical device manufacturing organization or Authorised Representative.
deviCE Sistemas has experienced staff with knowledge of the regulations for Medical Devices and In Vitro Diagnostics Medical Devices, as well as the ISO 13485 quality management system, being able to offer the service of Compliance Officer in an efficient way.
We have experienced staff who are knowledgeable about medical device regulations.