Medical Device Regulations come into force May 2021. Are you compliant?

Safeguarding Your Medical Device Software in the Changing Landscape

The clock is ticking for compliance with the Medical Device Regulations. In recent years, the healthcare industry has undergone rapid transformations, leveraging technology and software to enhance patient well-being and operational efficiency. This progress has prompted the European Union to introduce new guidelines for the Qualification and Classification of Software in Medical Device Regulation 2017/745.

As with any new regulations of this nature, there is a transition period for businesses to adapt. In the case of Medical Device Regulations, these new rules will be enforced from May 2021. (Annex VIII EU-MDR 2017/745 encompasses rules 9, 10, 11, 12, 13, 15, and 22 applicable to medical software.) Time is of the essence to make the necessary adjustments and ensure compliance with these regulations. We have already witnessed a surge in demand for MDR specialists, with companies seeking talent across various disciplines, including independent contractors, fixed-term positions, and permanent MDR specialists.

Enhancing Safety and Performance through Regulation
Software now plays a critical role in numerous healthcare products and is integrated into digital platforms used in medical care and healthcare settings. The new regulations expand the scope of rules to impose restrictions and requirements on manufacturers, aimed at enhancing safety, performance, and oversight of technologies and applications in the medical field that may be classified as medical device software.

Understanding Medical Device Software
According to the regulations, medical device software refers to a set of instructions that process human-delivered input data and generate output data through software. This output has an impact on the use of a medical device or a combination of devices. In short, if the software serves a medical purpose on its own, it falls under the purview of the new regulations. However, to add a layer of complexity, rules 3.3 and 3.5 state that the regulations also apply when the software is intended as an accessory to a medical device.

To determine if your software falls within the scope of the Medical Device Regulation, consider the following questions:
• Does it directly control a medical device?
• Does it provide information intended to guide healthcare professionals or patients in decision-making?
• Does it support healthcare professionals in their duties?
• Is it designed to process, analyze, or modify information with a medical purpose?

If any of these questions are answered with a "yes," compliance with the Medical Device Regulations becomes mandatory. Examples of medical device software may include:
• Blood glucose meters
• ECG interpretation software
• Image searching software

It's important to note that medical device software can exist in various locations, such as mobile phones, directly attached to the medical device, computers, or the cloud.

Ensuring Data Security
A crucial aspect is the security of data stored or processed by medical device software. Manufacturers must address potential breaches or malware attacks, promptly detect compromises, and be able to recover from such incidents. This responsibility extends not only to the initial development but also to the maintenance of the software. Measures that should be taken include:
• Patent protection and copyright registrations
• Cybersecurity protocols
• Regular integrity checks

Implementing these measures will help ensure the required level of protection against unauthorized access and manipulation.

Compliance with Regulatory Standards is Essential
Mitigating the risk of breaches in medical device software is a key objective of these regulations. By defining the scope of medical device software, these guidelines assist manufacturers and regulatory bodies in implementing appropriate and ongoing data protection measures. To meet the requirements of these regulations, it is imperative to achieve compliance before they come into effect. Regulatory agencies will take a firm stance on rule violations.

Now is the time to assess your staffing needs to avoid compliance gaps. Will you require project-based hires to address existing and future shortfalls, or is it more prudent to hire permanent employees such as MDR specialists to manage ongoing obligations under the MDR?

We are already assisting our clients in sourcing and recruiting the talent they need to be prepared for this new directive. Whether you require individual contractors or project teams, contact HERO today to discover how we can help you secure the necessary personnel for your organization.

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