TÜV Rheinland Expands CB Certification for Medical Device Cybersecurity Standard IEC 81001-5-1:2021

TÜV Rheinland announced that its Japanese subsidiary, TÜV Rheinland Japan, has been authorized to issue CB Test Certificates and CB Test Reports in accordance with IEC 81001-5-1:2021, effective February 27, 2026. TÜV Rheinland becomes the first organization in Japan to operate both as a National Certification Body (NCB) and a CB Testing Laboratory (CBTL) for this standard.

IEC 81001-5-1:2021 is an internationally recognized standard addressing cybersecurity across the entire lifecycle of health software and health IT systems. It is designed to enhance safety, effectiveness, and security in the development and maintenance of medical device software including Software as a Medical Device (SaMD) as well as healthcare IT systems.

By complying with IEC 81001-5-1:2021, manufacturers can effectively reduce cybersecurity risks and ensure the protection of sensitive healthcare data. CB certification further supports global market access by facilitating regulatory compliance in key regions such as the United States and the European Union, helping manufacturers streamline approval processes and accelerate time-to-market. In addition, independent third-party certification strengthens trust, enhances product quality perception, and reinforces long-term lifecycle security management.

Through its dual role as NCB and CBTL, TÜV Rheinland expands its global service portfolio in medical device cybersecurity and underlines its commitment to supporting the healthcare industry in addressing evolving digital risks. The organization is among a select group of certification bodies worldwide capable of delivering integrated services—from testing and auditing to certification—along the entire medical device value chain.

Leveraging its global network of experts and extensive regulatory know-how, TÜV Rheinland supports medical device manufacturers in navigating complex international requirements and technological challenges. Its comprehensive solutions enable clients to achieve compliance efficiently while enhancing product safety and competitiveness in global markets.