As genomic sequencing becomes increasingly integrated into clinical research, molecular diagnostics and healthcare, protecting sensitive genetic information is an essential consideration. MGI announces that its T1+ and G99 gene sequencers have both received the IEC 81001-5-1 IECEE CB Certificate from SGS, recognizing their compliance with an internationally recognized framework for cybersecurity in health software and medical devices.
Cybersecurity: A critical consideration in genomic sequencing
Genetic data is particularly sensitive. It can contain information relating to an individual's health, inherited characteristics and potential disease risks. For hospitals, diagnostic laboratories and research institutions handling patient-derived samples, maintaining the confidentiality and integrity of this information is a fundamental responsibility.
As sequencing technologies become increasingly connected to laboratory information systems and digital infrastructures, medical devices must also be considered within the broader cybersecurity landscape. Potential vulnerabilities, unauthorized access and cyberattacks can create risks for both laboratory operations and sensitive information.
At MGI, cybersecurity is therefore addressed as an integral part of product development and lifecycle management, with the objective of supporting customers in maintaining secure and reliable sequencing environments.
Two MGI sequencers achieve IEC 81001-5-1 certification
Following the certification of the T1+ benchtop sequencer, MGI's G99 gene sequencer has also officially received the IEC 81001-5-1 IECEE CB Certificate, awarded by SGS.
The IEC 81001-5-1 standard establishes requirements for managing cybersecurity throughout the lifecycle of health software and medical devices. The certification process involves assessing cybersecurity-related practices and controls, from product development through manufacturing and post-market activities.
For the T1+ and G99, the certification reflects a systematic approach to cybersecurity, incorporating processes such as:
Secure product development: integrating cybersecurity considerations from the earliest stages of product design.
Code audits and threat modelling: identifying potential security weaknesses and assessing cybersecurity threats.
Security testing: including vulnerability scanning and independent third-party penetration testing.
Manufacturing and quality control: maintaining cybersecurity-related requirements throughout production.
Post-market monitoring: establishing processes to identify, assess and respond to potential vulnerabilities throughout the product lifecycle.
This lifecycle-based approach goes beyond assessing a product at a single point in time. It supports the continuous consideration of cybersecurity as products evolve and remain in use.
As of November 2026, the T1+ and G99 are among the very few gene sequencers worldwide to have received this specific medical device cybersecurity certification under the IECEE CB Scheme.
From individual instruments to a portfolio-wide cybersecurity commitment
The certification of both the T1+ and G99 reflects MGI's broader commitment to embedding cybersecurity into its sequencing portfolio.
Rather than being limited to individual product assessments, this approach is supported by an enterprise-wide cybersecurity management framework, covering product development, testing, quality management and post-market vulnerability response.
MGI is continuing to extend this approach across its product range. The T7+ has already entered the certification process, with further efforts underway to expand cybersecurity certification coverage across the portfolio.
This progressive approach aims to provide customers with independently assessed cybersecurity practices across an increasing number of sequencing solutions.
Supporting confidence in sensitive genomic data management
For clinical laboratories, hospitals and research institutions, selecting a sequencing instrument involves more than evaluating throughput, sequencing accuracy and cost per sample. The cybersecurity framework supporting the instrument is also an important consideration, particularly when working with sensitive human genomic data.
The IEC 81001-5-1 certification provides independent recognition of the cybersecurity processes assessed for the T1+ and G99. It offers customers an additional, verifiable reference when evaluating the cybersecurity practices associated with their sequencing infrastructure.
The IECEE CB Scheme also facilitates international recognition of relevant test results and certificates across its member countries, helping streamline the process of meeting applicable national certification and regulatory requirements.
At MGI, data security is considered as important as data accuracy. With the T1+ and G99 now IEC 81001-5-1 certified, MGI is reinforcing its commitment to integrating cybersecurity throughout the lifecycle of its sequencing instruments. By combining technological innovation with systematic cybersecurity practices, MGI aims to support laboratories in advancing genomic research and diagnostics while addressing the growing importance of data confidentiality and protection.
Genomic sequencing cybersecurity
cybersecurity
Genomic
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