We are extremely proud to receive high praise for our fast and effective In Vitro Diagnostic Medical Device Regulation (IVDR) certification process.
A self-testing IVD manufacturer in China, which wishes to remain anonymous due to the competitive nature of its market, was so impressed by our dynamic service that it took the time to send a letter of commendation and a trophy to our team.
The letter included: “This remarkable achievement would not have been possible without SGS’s professionalism, rigorous testing, authoritative certification services and exceptional technical support throughout the entire IVDR compliance process.
“We hereby express our sincere gratitude for SGS’s outstanding expertise, reliable service and valuable partnership. We look forward to continuing our strategic cooperation in global quality certification, regulatory affairs and market development, and to jointly prompt higher standards in the IVD industry.”
We guided the client through the entire process, certifying its self-testing device under the highest risk classification, Class D. The device is defined as having high individual and high public health risk, and required a strict Notified Body (NB) assessment. The process only took a few months, pleasing the client, who was keen to enhance its already robust offering.
Nakisa Harmes, Global Head of Medical Devices at SGS, received the honors on her team’s behalf during its recent Global Medical Device Conference in London, UK. She added: “We are incredibly grateful to our client for such a beautiful gesture, kind words and praise. It’s amazing to hear how our efficient service has helped them take their device to the next level. We wish them all the best for the future and look forward to supporting the next client on their IVDR pathway.”
Why SGS IVDR certification?
As one of the largest designated NBs under the IVDR, we can fast-track your conformity assessment and technical documentation review – helping to bring your device to the EU market quickly and efficiently.
With growing demand, tight regulatory deadlines and limited capacity across many other NBs, we provide a faster and more flexible route to IVDR compliance. Our dedicated IVD team has the expertise and availability to support new projects. We can also help you transfer NB to avoid backlogs and accelerate your time to market, providing exceptional value without compromising quality or compliance.
Whether you're new to the IVDR or already registered with an NB, we are here to support you every step of the way. Our global network of expert auditors and product assessors provides local insight with international reach, helping a wide range of IVDs achieve certification, including:
- Immunogenetics, genetics of cancer and inherited conditions
- Cancer markers
- Infectious disease markers
- Clinical biochemistry and other general analytes
- Sterile IVDs
- In vitro diagnostic medical device software (IVD MDSW)
- Self-tests and near-patient tests
Once your conformity assessment is complete, we issue an IVDR certificate, enabling you to affix the CE mark and legally place your device on the EU market. Certification is valid for five years and requires ongoing surveillance, including post-market follow-up, sampling and/or testing.
Multiple medical device approvals
As the world's leading testing, inspection and certification company, we offer decades of experience and expertise as a one-stop shop for all medical device compliance, from EU Medical Device Regulation (MDR) services and ISO 13485 (quality management systems, or QMS) certification to UKCA for the UK and multi-market access with the Medical Device Single Audit Program (MDSAP). We are:
- An NB in Belgium (1639) for the IVDR and MDR
- An NB in Finland (0598) for Software as a Medical Device (SaMD) certification
- An Approved Body (0120) for the UKCA mark
- An Approved Auditing Organization (AO) for MDSAP
Contact our team or visit our IVDR web page today to learn more about how we can expedite your IVDR journey.
About SGS
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of over 100,000 dedicated professionals. With more than 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and a portfolio of trusted specialized brands, including Applied Technical Services, Brightsight, Bluesign and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN SW).
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