Enhanced patient and user safety
An independent, in-depth assessment of your safety architecture ensures that Basic Safety and Essential Performance are reliably maintained—even under single fault conditions.
As a manufacturer of active medical devices for the European market, you are responsible for bringing a safe, reliable product to market—on time and within budget—while demonstrably complying with the EU MDR and all applicable standards.
Essential Performance Safety (EPSA) plays a decisive role in achieving this goal, as it directly impacts patient safety, regulatory acceptance and long-term product success.
Medical device manufacturers face growing challenges when it comes to ensuring single fault safety. Limited experience regarding single fault safety could lead to weaknesses in system concepts, design decisions or implementation, resulting in costly redesigns, development delays and avoidable risks for patients and users. These challenges are compounded by gaps between MDR requirements and IEC 60601-1: the standard only partially covers MDR requirements related to single fault safety, in particular GSPR 17.1 (see EN 60601-1:2006/A13:2024). As a result, relevant risks due to single fault conditions of the device may remain unidentified, which can cause deficiencies in technical documentation and complications during regulatory assessment. At the same time, manufacturers are exposed to increasing regulatory, economic and reputational risks. Incomplete risk analyses significantly increase liability exposure, while safety deficiencies can undermine trust in your product and brand in an increasingly regulated and highly competitive market environment.
Your value with TÜV SÜD
Early risk mitigation instead of late corrections
Safety critical system aspects are identified and addressed early in development, helping you avoid costly iterations and keep projects on schedule.
Regulatory confidence and clarity
Compliance with relevant requirements is assessed by a qualified, independent body and documented in a transparent and traceable manner—providing a solid basis for audits and conformity assessments.
Robust documentation for market approval
Highquality, independent, internationally recognised and accredited test reports reduce follow-up questions from Notified Bodies and authorities, supporting a smoother approval process.
Expert support for standards and testing
Our specialists support you in interpreting and applying complex normative and regulatory requirements—pragmatic, solution oriented and tailored to your specific product.
Why TÜV SÜD
Over 20 years of experience
in assessing single fault safety of medical devices
Specialised expert teams
for IEC 60601-1 and relevant particular standards
Proven expertise with complex medical devices
including dialysis systems, CT scanners and networked devices
Holistic support throughout the development lifecycle
from early concept phases over market approval to change notifications
Accredited and internationally recognised testing laboratory
trusted for safety, quality and regulatory competence
Our services
- EPSA Early-Stage
Assessment and Testing in an early design phase
- EPSA Concept Assessment
Assessment of the safety architecture prior to prototype development
- EPSA Full Scope
Comprehensive EPSA including concept analysis, test planning, and execution of tests
- EPSA Plus
Upgrade of an existing CB 60601-1 test report to a full EPSA scope
- EPSA Training
Training about single fault safety at the TÜV SÜD Academy
Please contact us for further information:
Disclaimer: TÜV SÜD's certification and testing services are independent of each other and do not impact one another. Our certification services are delivered by TÜV SÜD's recognised Certification Bodies, while our testing services are conducted through TÜV SÜD Testing Labs.