SSCP, IFUs, and IFPs 

Get a compliant SSCP, IFUs, and IFPs, as per the Medical Device Regulation (EU) 2017/745 (MDR)

Summary of Safety and Clinical Performance (SSCP) for intended users

As per the Medical Device Regulation (EU) 2017/745 (MDR), all Medical Device Manufacturers of Implantable devices and class III devices other than custom-made devices must submit an SSCP to the Notified Bodies as a regulatory compliance requirement. These are intended to provide public access to clinical safety and performance of their medical devices.

Our writing experts at Aolete support manufacturers to develop and update both Health Care Professional and lay persons specific SSCPs that fulfill the objectives of the Medical Device Regulation to enhance transparency and provide adequate access to information. We further support the determination of readability for the lay person’s SSCP in relation to justifiable acceptance criteria. 

Instructions For Use (IFUs) and Instructions For Patients (IFPs)

Medical device labeling: Instructions for use for both users and patients are a fundamental requirement for all Medical device manufacturers.

At Aolete, we support manufacturers to update and develop Instructions For Use (IFUs) and Instructions For Patients (IFPs) that meet regulatory needs.