Risk management standards are an important aspect of the development of medical devices. Patients are already in a vulnerable position and, during diagnosis and treatment, they should be protected from risks that could further impact their health.

International medical device manufacturing standard BS EN ISO 14971 was developed to provide a process to assist manufacturers in identifying the hazards associated with medical devices, assessing the corresponding risks, controlling these risks where needed, and monitoring the effectiveness of the risk control measures.

The third edition of this standard was published in December 2019, followed in June 2020 by the updated companion report PD CEN ISO/TR 24971, which provides extensive guidance on the application of the standard. A transitional period of 3 years following publication is usual to allow all stakeholders to adapt to the requirements in the new edition.

Risk Management Regulations for Medical Device Manufacturers

Performing risk management became an essential requirement for medical device manufacturers in order to comply with industry regulations. The risk management requirements only covered risk analysis and were expressed in general, not very specific terms. Risks needed to be reduced as far as possible while taking account of the generally acknowledged state of the art and maintaining a high level of protection of health and safety.

Similar requirements can be found in the regulations of other countries.

The risk management process described by standard BS EN ISO 14971 consists of several steps which apply to the design, development, and production of every medical device. It is important to recognize that these steps need to be documented in procedures in the manufacturer’s organization.

The procedures for risk management can be embedded in a quality management system, but this is not required by BS EN ISO 14971. The reason is that regulations in some countries do not oblige manufacturers of low-risk medical devices to implement a quality management system. However, if a manufacturer has implemented a quality management system, such as BS EN ISO 13485 it is recommended to integrate the risk management procedures into that system.

In this context, it is emphasized that the European MDR and IVDR require the manufacturer to implement a quality management system that addresses risk management.

To read more about quality management systems for medical devices, click here.

What is Medical Device Standard BS EN ISO 14971?

Recognized by regulatory authorities in the US, Canada, Europe, and more, international standard BS EN ISO 14971 helps medical device manufacturers establish, document, and maintain a systematic risk management process across all phases of the lifecycle of a medical device.

The process described will help medical device manufacturers:

• Identify the hazards associated with the medical device

• Estimate and evaluate the associated risks

• Control these risks

• Monitor the effectiveness of the controls

The risk management standard’s requirements apply to all phases of the life cycle of a medical device. The process described applies to risks associated with a medical device, such as those related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. It can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device lifecycle.

The use of the risk management standard helps streamline the regulatory processes that enable entry to selected markets.

It is used by all parts of the medical device industry, and by organizations dealing with the design, development, production, installation, or servicing of medical equipment, devices, and technology.

There is no doubt that using standards can help you to manage risk in the manufacturing of your medical devices, building crucial trust between you and the rest of your supply chain. With a BSI Knowledge subscription, quality, risk management, and compliance are at your fingertips. Build your own custom collection of standards, or opt for access to our GBM05 Sciences & Health Care module for instant access to over 4,800 documents. Request to learn more.

Ensure your organization is complying with regulations and managing medical device risks effectively by adding standard BS EN ISO 14971 to your collection today.