New and already approved medical devices on the EU market will be subject to the new EU regulation on medical devices ((EU) 2017/745 -MDR) from 26 May 2020. The customer aims to renew the product approval and registration of its medical devices in the areas of medical vacuum technology and obstetrics in accordance with (EU) 2017/745. Structure, content and scope of the existing risk management files do not comply with the current regulatory requirements of (EU) 2017/745 and ISO 14791. PTA supports the customer in remediating and coordinating the risk management files in accordance with regulatory requirements, generating them audit-proof and storing them in the customer-specific quality management system.
The customer is internationally operating in the fields of medical vacuum technology and obstetrics.
From 26 May 2020, all medical devices marketed in the EU must comply with the new MDR or be withdrawn from the market. Since the MDR imposes much stricter requirements than the previous MDD directive, manufacturers will have to fundamentally review and partially revise their documentation. The PTA tasks include gap analyses and the remediation of risk management plans, product risk analyses and risk management reports in accordance with the customer's regulatory requirements under (EU) 2017/745 MDR. Special attention is paid to the complete and correct disclosure of residual risks in the risk management report and the instructions for use.