Software as a Medical Device: smarter compliance with regulations

Published in: Medical Devices
Published on: 19 April 2024
person writing medical information

As of May 26, 2021, the Medical Device Regulation (MDR) is enforceable for all medical devices in Europe. This new legislation has significant implications for both app developers and manufacturers of software for medical purposes (MDSW), with stricter requirements and an expanded definition of software as a medical device. The MDR, along with related ISO standards, are just a few of the many regulations that must be adhered to. How do you maintain an overview and ensure ongoing compliance with all these requirements? Certification Experts, a part of the Kader Group, offers solutions!

Software in modern healthcare

There is a growing demand for alternative forms of healthcare, such as preventive care, and an increasing need for long-term and remote care. Technology and appropriate software play a crucial role in diagnostics, treatment, and patient care. The concept of ‘Software as a Medical Device’ (SaMD) has led to obligations for certification processes by notified bodies and the establishment of technical files and management of processes by manufacturers to ensure the safety and effectiveness of this software.

Compliance challenges in Medical Devices

Organizations involved in the production or distribution of medical devices face different of legal obligations, particularly under the Medical Device Regulation (MDR), the successor to the Medical Device Directive (MDD).

What are some key points to keep in mind?

• Risk classification under the MDR: With the introduction of the MDR, software is often subject to a higher risk class.

• Quality system according to ISO 13485:2016: To ensure that product(s) and the quality system comply with the requirements of the MDR, organizations implement a quality system that need to be certified.

• Organizations must have a complete technical file, and in most cases, they must submit it to a Notified Body for thorough evaluation by an expert. After a positive assessment, they issue an EC certificate (for product compliance) and an ISO 13485 compliance certificate.• Registration obligations: Organizations must fulfil various registration obligations, such as registration in EUDAMED

• If your organization is located outside the EU, it must appoint an authorized representative(EC REP) and an importer (IM). Both need to be registered in EUDAMED in these roles.

The importance of a Quality Management System (QMS)

In addition to the aforementioned obligations, the implementation of a Quality Management System (QMS) is essential for manufacturers, distributors, and importers of medical devices. Even if not legally mandated, a QMS can be valuable, for example, as a requirement from suppliers or customers. A QMS provides a structured approach to meeting and maintaining compliance with laws and regulations, ensuring compliance even as laws change.

In collaboration with BMGRIP, Certification Experts can not only guide you with the (e)QMS but also provide you with a digital platform, SmartManSys. SmartManSys is a digital platform that documents processes and product requirements, focusing on process execution and continuous improvement within your organization. It is a platform that simplifies the addition of new standards and the combining of documents, eliminating the need for duplicate work. With SmartManSys’ smart tools, you can easily integrate multiple standards and documents into one comprehensive management system.

Advice and support from Certification Experts

Certification Experts, a part of the Kader Group, is ready to support you in ensuring compliance with European requirements for your software as a Medical Device. We can assist you with setting up a QMS, obtaining CE marking for your software under the MDR, and even take on the role of Authorised Representative and/or PRRC. Work with Certification Experts to navigate the steps for CE marking of medical devices and ensure that your QMS guarantees and enhances the quality and safety of your software as a Medical Device.

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