In a world with few In Vitro Diagnostic Medical Device Regulation (IVDR) Notified Bodies (NBs), we stand ready to fast-track your application and entry to the EU market.
Combining our world-leading testing, inspection and certification position with decades of medical device regulatory knowledge, we have the capacity to get you to where you need to be.
We are:
- A Notified Body in Belgium (1639) for the IVDR and Medical Device Regulation (MDR)
- A Notified Body 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 the Medical Device Single Audit Program (MDSAP)
The IVDR regulates in vitro diagnostic medical devices placed on the EU market. It aims to improve the safety and efficacy of IVDs, ensuring patient clinical safety and creating a transparent and robust framework for manufacturers and healthcare professionals.
If you have in vitro diagnostic medical devices certified under the IVDD, you must lodge a formal application for conformity assessment with a Notified Body, such as SGS Belgium NV – Notified Body 1639, by one of the following deadlines, which depend on the risk classes of your devices:
- May 26, 2026: Class C devices that were self-declared under the IVDD
- May 26, 2027: Class B devices and Class A sterile devices that were self-declared under the IVDD
You must also sign a written agreement with a Notified Body up to four months after the relevant deadline and have an IVDR-compliant quality management system (QMS) in place.
SGS is a designated IVDR Notified Body. We can perform conformity assessments against IVDR in your country.
Our expert auditors and product assessors can support you in bringing a wide range of IVDs to the EU market, 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
We will issue you a certificate for your in vitro medical device following a successful conformity assessment. This enables you to affix the CE mark to your device and legally place it on the EU market. The certificate must be renewed every five years and is subject to annual surveillance, post-market follow-up, sampling and/or testing.
Discover how we can expedite your journey now.
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 99,500 dedicated professionals. With over 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 trusted specialized brands, including Brightsight, Bluesign, Maine Pointe 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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