IVDs are tools and instruments used to perform tests on patient samples, such as blood, urine, tissue or other bodily fluids. These devices detect diseases, conditions or infections, monitor health status and determine treatments or medication dosages.
The EU In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746 entered into force on May 26, 2017, replacing the EU In Vitro Diagnostic Medical Devices Directive (IVDD). In vitro diagnostic medical devices (IVDs) placed on the EU market must be certified against the new requirements.
What is the IVDR?
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.
Key changes from the IVDD include:
- Expanded scope of products to be considered IVDs
- Changes in device classification (from Class A devices with the lowest risk to Class D devices with the highest risk)
- Stricter oversight of manufacturers by Notified Bodies
- Enhanced requirements for post-market surveillance
- Increased transparency through the Unique Device Identification (UDI) system and the European Database on Medical Devices (EUDAMED)
Transitioning from IVDD to IVDR
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, 2025: devices covered by an IVDD certificate and Class D devices that were self-declared under the IVDD
- 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.
Getting your CE mark from SGS
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.
Why SGS?
We are the world's leading testing, inspection and certification company, with decades of experience and expertise in medical devices regulatory compliance. 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)
Contact us to discuss your IVDR compliance needs.
Frequently Asked Questions (FAQs)
IVDR certification is a compliance requirement set by the European Union to ensure the safety and performance of IVDs. This certification is essential for manufacturers looking to market their devices within the EU.
IVDR certification is crucial, as it ensures that in vitro diagnostic devices meet stringent safety and performance standards. It not only allows you to access the EU market but also enhances the trust healthcare professionals and consumers have in your products.
Manufacturers of in vitro diagnostic medical devices who intend to place their products within the EU. This includes companies of all sizes, from large multinationals to small startups.
Key requirements for IVDR certification include:
- Classifying the device based on risk, following the IVDR classification rules
- Implementing a compliant quality management system (QMS), such as an ISO 13485 QMS
- Preparing technical documentation and a performance evaluation report
- Compiling sufficient clinical evidence to demonstrate device safety and efficacy. This is likely to include conducting clinical performance studies
- Engaging a Notified Body for a conformity assessment
Non-compliance with the IVDR can result in severe penalties, including withdrawal of your product from the EU market, fines and legal action. Additionally, non-compliance can damage your company's reputation and endanger customer trust in your brand.
This will vary, depending on your device's classification and how complete your documentation is. On average, the process can take several months to a few years. Ensuring readiness and early engagement with a Notified Body can help expedite the process.
All IVDs newly placed on the EU market must comply with the IVDR’s regulatory requirements. Providing that several requirements are satisfied, legacy devices that were placed on the market under the IVDD by self-declaration may continue to be placed on the market, based on a transitional timeline that depends on the device’s new IVDR classification:
- December 31, 2027, for devices covered by an IVDD certificate, and Class D devices
- December 31, 2028, for Class C devices
- December 31, 2029, for Class B and Class A sterile devices
These extended transitional timelines apply only if you satisfy a series of conditions, notably engaging with a Notified Body at the latest 2.5 years before the relevant deadline. You should contact a Notified Body, such as SGS, regarding the transition arrangement before the statutory deadline.
Notified Bodies are independent organizations designated by EU member states to assess the conformity of in vitro diagnostic devices. They play a critical role in the IVDR certification process by reviewing technical documentation, conducting audits and issuing certificates of conformity.
To ensure continuous compliance with the IVDR, your company should:
- Regularly update its quality management systems
- Monitor regulatory changes and updates
- Conduct periodic internal audits
- Maintain comprehensive documentation
- Engage with Notified Bodies for ongoing assessments and re-certifications
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