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risk Management & market entry

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Technical Risk Management
Risk Management is of central importance. The manufacturer is obliged to install a risk management process and to keep it updated. Aim is to generate objective evidence that the application of a medical device is safe and effective and that the risk-benefit ratio is acceptable over its entire lifecycle.

The Risk Management File according to the harmonized standard ISO 14971 is one of the most important part of the Technical Documentation. The manufacturer is obliged to demonstrate that his medical device is applied safely and effectively in its Intended Use by the user, the risk-benefit ratio is acceptable for the user, the patient and for third parties. The Risk Management File has to be generated prior to the Clinical Evaluations and needs to be kept updated.

The core document of the Risk Management File ist the risk assessment, which identifies, evaluates and mitigates risks which are associated with the use of the medical device. The manufacturer has to show evidence how identified risks are mitigated and how effective these measures are.

In a wider sense Vigilanceas well as proactive Post-Market Surveillance (PMS) Activitiesand Post-Market Clinical Follow-up (PMCF) Studiesbelong to Risk Management.

Risk Management has a close connection to Usability Engineering of a medical device according to the harmonized standard EN 62366. The manufacturer is obliged to install a Usability Engineering File and to keep it updated. This file is required to show evidence that the user is able to apply the medical safely and effectively according to its Intended Use. Particularly environmental conditions of use (lighting conditions, noise level or heat/cold, etc.), psychophysical parameters like mental distress as well as knowledge and education of the user (layperson, trained personal) needs to be considered.

Regulatory Risk Management
In contrast to medicaments medical devices are allocated to risk classes by applying classification rules. Depending on the identified risk class regulatory requirements and requirements for registration, certification or approval are defined and need to be considered by the manufacturer. Risk Classification criteria are based on the guidelines of the International Medical Device Regulators Forum (IMDRF) – the successor organization of the Global Harmonization Task Force (GHTF). Their principles also are applied by the Medical Device Regulation and the In vitro Diagnostic Device Regulation (MDR and IVDR, resp.). While a trend can be observed for unified risk classification rules the regulatory files for registration, certification or approval still country- or region-specific.

Criteria for the risk classification of medical devices are e.g. invasiveness, length of stay in the human body, inherent risk of the material used, disease to be treated and in the case of in vitro diagnostic medical devices the application for transplantation or transfusion medicine and pregnancy monitoring and prenatal care.

medlaQ - Consulting for medical devices

Dr. Bernhard Gerstenecker

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