Risk management is a continuous iterative process throughout the entire lifecycle of a medical device. Its purpose is to account for and reduce risks associated with the use of the device. Risk management system must be documented and requires regular systematic updating. Risk management plan is the pivotal document of the Risk Management System.

European Union, USA and Mexico require that all manufacturers of medical devices develop and maintain Risk Management Systems regardless of risk-classes of their devices. In Mercosur countries (Argentina; Brazil; Paraguay; Uruguay) and associated states (Suriname, Guyana, Colombia, Ecuador, Peru, Chile and Bolivia) Risk Management System is a requirement for high-risk products.

Risk Management System requirements for the European Union are laid down in Annex I of Regulation EC 2017/745 (2017/746 - for in vitro medical devices). In the USA corresponding provisions are set out in the Code of Federal Regulations - 21 CFR 820.30 and in the FDA guidance Q9.

A number of methods and instruments are used for risk analysis and management. Some of them are ISO 14971, FMEA, HAZOP, FTA etc. Different medical devices require different risk management approaches.

Risk Management System is closely related to the Post-Market Surveillance System and Clinical Follow-Up and is an integral part of the Quality Management System. It should be incorporated within research and development processes and reflect the engineering aspects of a product and risks associated with them.

Medical device manufacturers who want to sell their devices on global markets need to create a Risk Management System and manage risks associated with the use of each of their products. MDRS assists medical device companies with risk management. We will develop and implement a Risk Management System that is compliant with regulatory requirements of your target markets.

Post-market Surveillance System is an integral part of the medical device manufacturer's Quality Management System. How the system is organized and how it works depends on risk-based classification of products the company manufactures and sells. Post-market Surveillance System is a binding regulatory requirement in the EU, USA and some other countries. In Latin American countries the regulatory authorities expect that it is Authorized Representatives who have Post-market Surveillance Systems and not importers.

The post-market surveillance system shall be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions.

In the European Union post-market surveillance is regulated by Articles 83-86 of Chapter VII and Annex III of Regulation EC 2017/745 or by Section 1 of Chapter VII and Annex III of Regulation EC 2017/746. In the USA post-market surveillance provisions are laid down in section 21 CFR Part 822 of the Code of Federal Regulations.

The basic documents of any Post-Market Surveillance System are Post-Market Surveillance Plan and Post-Market Surveillance Reports. In the European Union and USA manufacturers of high-risk medical devices (e.g. classes IIb and III in the EU or class III in the USA) must provide Periodic Safety Update Reports (PSUR) to the regulators. In some countries (for instance, in the USA) regulators may request intermediate post-market surveillance data and carry out surprise inspections of manufacturers' Post-Market Surveillance Systems.