SGS – Your partner for IVD testing and certification
In vitro diagnostics (IVD) encompasses products used to analyze samples from the human body, such as blood, tissue, or urine. The analysis results provide critical information for medical diagnoses, therapy monitoring, and preventive healthcare.
All IVD products in the European Union are subject to the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), which sets strict requirements for product safety, performance evaluation, clinical evidence, and technical documentation and replaces the former Directive 98/79/EC.
In addition to reagents, test kits, and software, electrical analyzers and automated laboratory systems used in IVD also fall within the IVD environment. These devices have additional requirements, particularly regarding product safety and electromagnetic compatibility (EMC). Compliance with international standards such as IEC 61010 (product safety) and IEC 61326 (EMC) is essential for market approval and safe operation.
SGS supports manufacturers with comprehensive testing and certification services – from testing during the development phase to international certification and market access.
Product safety testing for IVD devices according to IEC 61010
Electrical devices and automated systems used in IVD must meet extensive safety requirements. Relevant standards include:
- IEC 61010-1 – General safety requirements for electrical equipment for measurement, control, and laboratory use
- IEC 61010-2-101 – Safety requirements for in vitro diagnostic (IVD) medical equipment
These standards cover safety aspects such as:
- Protection against electric shock and mechanical hazards
- Testing under single-fault conditions
- Markings and documentation
- Mechanical strength and durability
- Protection against fire propagation
- Device temperature limits and heat resistance
- Protection against hazards from fluids and solid foreign objects
- Radiation protection, including lasers, acoustic, and ultrasonic pressure
- Protection against released gases, substances, explosion, and implosion
- Components and assemblies
- Safeguarding through interlocks
- Hazards arising from intended use
- Risk assessment
EMC testing for IVD devices according to IEC 61326
Electrical and electronic IVD devices must comply with the electromagnetic compatibility (EMC) requirements defined in the IEC 61326 series. Relevant standards for IVD devices and systems include:
- IEC 61326-1 – General EMC requirements for electrical equipment for measurement, control, and laboratory use
- IEC 61326-2-6 – Particular requirements for medical in vitro diagnostic (IVD) medical equipment
Our EMC testing services include:
- Radiated and conducted emission testing
- Radiated and conducted immunity testing
- Special requirements for medical devices
Product certification and global market access
- The IEC 61326 and IEC 61010 standards form the basis for CB certification, significantly simplifying approvals in target markets.
- European versions of the EN 61010 standards provide the basis for your CE declaration of conformity.
- For the North American market, UL 61010 and CAN/CSA-C22.2 No. 61010 standards enable corresponding certification.
- With SGS North America certification, you gain market access in the USA and Canada –country deviations and certification can be seamlessly integrated into existing test programs.
IVDR Certification for In Vitro Diagnostics
The European Commission has officially recognized SGS Fimko Oy as a Notified Body (NB 0598) under IVDR (EU) 2017/746. SGS Fimko Oy is authorized to assess the conformity of in vitro diagnostics within its scope – for nearly all types of IVD products.
In close collaboration, SGS Germany GmbH supports manufacturers with IVDR certification.
Your benefits:
- Certification according to the highest regulatory standards
- Local support through SGS in Germany
- Efficient and transparent certification processes
More information and the scope of competence of SGS Fimko can be found here.
Additional services from the SGS Group
- Environmental simulation: Testing devices and systems for mechanical, climatic, and corrosive influences, including IP degree of protection testing, tightness tests, transport and drop testing, and qualification of connectors and connection technologies
- Chemical product testing: Analysis of unwanted and restricted substances, including RoHS compliance, to ensure limits for heavy metals such as cadmium, lead, mercury, chromium VI, and selected brominated flame retardants are met
- Biocompatibility testing according to DIN EN ISO 10993 standards
- Functional Safety
- Cybersecurity
Your benefits with SGS
Our experienced test engineers, some active in international standardization committees, guide you expertly through the entire testing and certification process. This ensures your products reach the market quickly, reliably, and in compliance with standards.
Our test laboratory in Puchheim, near Munich, offers:
- Accreditation according to DIN EN ISO/IEC 17025 by DAkkS
- International recognition via ILAC (International Laboratory Accreditation Cooperation)
- Recognized CB test laboratory under the IECEE CB Scheme. Additional information regarding the CB scheme is available here.
- Recognition as a conformity assessment body (CAB) in the electromagnetic compatibility (EMC) sector by the German Federal Network Agency. Click here for additional information.
- Accreditation SGS North America Certification Mark
- Access to international certifications through a global network of laboratories and certification bodies
These capabilities significantly simplify and accelerate the approval of your products in international markets.
Contact
Armin Hudetz
t: +49 89 787 475-133
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Customer Service Team
t: +49 89 787 475-222
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