01. What is EU MDR?
EU MDR 2017/745 and IVDR 2017/746 are European technology standards that place stringent mandatory clinical quality, safety and security requirements on hardware medical devices and solutions classified as Software as a Medical Device (SaaMD). MDR compliance is a core component of CE certification and renewal.
03. How do we become compliant?
Becoming compliant requires clinical specialists with appropriate risk management experience to develop rigorous risk analysis documentation including a Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER). Explicit reference must also be made to cybersecurity best practice based on relevant industry standards for each product in your portfolio.
02. Does MDR apply to my company?
If you manufacture medical devices or software solutions that can impact clinical decision making then MDR applies to each relevant product within your portfolio. If you do not believe your solutions fall under MDR you must complete a Medical Device Eligibility Assessment to demonstrate why not.
04. How can The AbedGraham Group help?
Our clinical specialists are regulatory experts in the risk management of medical 'Internet of Things' (IoT) devices and clinical software solutions. They can complete all your relevant clinical and security documentation and act as signatories to represent your organisation to customers and regulators. Our experts will also complete Medical Device Eligibility Assessments for vendors that need to prove why their solutions are not medical devices.