We are bringing our genetic analysis software to CE-IVD marking, the European standard for in vitro diagnostic medical devices. We share how we are doing it, step by step and without shortcuts.
Who checks that a genetic test does what it claims? It is a reasonable question. When you receive a report on your genetic susceptibility, carrier status, or response to a medication, you trust that solid science, controlled processes, and responsible people are behind it.
In Europe, that trust has a name: Regulation (EU) 2017/746 on in vitro diagnostic medical devices, known as IVDR. At tellmeGen, we are submitting our software to assessment by a notified body, as required by the Regulation. And we want to do it openly: what we are doing, where we stand, and what it means for you.
And we share this for another reason: we believe this path should be the standard for any company offering genetic tests in Europe.
What CE-IVD marking is and why it affects genetic tests
The CE-IVD marking indicates that an in vitro diagnostic product complies with European Union safety and performance requirements. It applies to any product that obtains health information from a human sample. And that includes the software that analyzes and interprets your DNA.
The IVDR has applied since May 2022 and changed the rules of the game:
• Before, under the previous directive, most manufacturers self-declared that their products complied.
• Now, the vast majority need a notified body—an independent entity designated by European authorities—to review their quality system and technical documentation.
• Genetic tests are in class C, one of the most demanding classes, because the information they provide can influence important health decisions.
Our software is in class C. That is why it requires assessment by a notified body: simply declaring compliance is not enough.
A healthcare service, provided by professionals
tellmeGen is the brand of GENELINK, an authorized healthcare center in Spain. When you order a test, you are not buying a computer program: you are hiring a healthcare service.
• The software is used by our professionals. GENELINK geneticists, bioinformaticians, and physicians use it to analyze your data. You do not operate the software yourself: you receive the already reviewed result.
• The laboratory generates the data; the interpretation is ours. European laboratories process your sample and deliver the raw genetic data to us. The analysis and interpretation are performed by us.
• In Spain, with medical evaluation. In Advanced and Ultra, a prior questionnaire and a physician's prescription precede the analysis. If not prescribed, we refund the amount. Each report is validated by a geneticist, and the subsequent consultation with a geneticist is free.
While the certificate arrives: the "in-house" pathway. European regulations allow a healthcare center to manufacture and use its own products to care for its patients, without selling or transferring them to third parties, under strict requirements for quality, validation, and surveillance (Article 5.5 of the IVDR). This is the pathway we are formalizing in Spain, in parallel with certification. These are two compatible paths: the in-house regime for Spain while the certificate arrives; the CE-IVD marking for all of Europe.
Our 8-step roadmap
1. Precisely define the product. What it analyzes, who it is for, who uses it, and what it does not do. Our reports are predictive and informative: they are not a diagnosis.
2. Certify the quality system. The entire process, from design to user care, is governed by the ISO 13485 standard. We are certifying it with BSI, the same organization evaluating the product.
3. Demonstrate the scientific evidence of each report. Each of our more than 580 health-related reports must be backed by published science, reliable measurement, and correct interpretation.
4. Develop the software as a medical device. With a documented lifecycle, testing, version control, and cybersecurity.
5. Manage risks. We analyze what can go wrong—from sample collection to reading the report—and how to prevent it.
6. Designate responsible persons. We have a person responsible for regulatory compliance and a team of geneticists, bioinformaticians, and physicians.
7. Be transparent. Every claim we make—on the web, in reports, or on this blog—is reviewed against its evidence.
8. Monitor the product afterward. The certificate is not the end: we track real-world usage experience and update reports as science advances.
The technical side: identified and controlled software
A medical device must be unambiguously identifiable. Ours is tellmeGen software, with product code TMG-CEIVD-SW-01 and Basic UDI-DI 8437015506TMGSW9Y. That is the unique European identifier under which it will appear in EUDAMED, the European database on medical devices. Each configuration (Starter, Advanced, and Ultra) also has its own identifier, and every version of the software is registered with its number.
Some of the technical controls protecting your result:
• The most demanding safety class. We develop the software under class C of the IEC 62304 standard, the strictest for medical software.
• If quality falls short, there is no result. Every sample undergoes automated quality controls. In whole genome sequencing, if coverage does not reach 20x (meaning each position has not been read at least about 20 times on average), the result is held back and reviewed by our team before publication.
• What has not been read is not assumed normal. If a position in the genome could not be read with sufficient quality, the report does not present it as "no variant": it marks it as not evaluable.
• Reference tools. We identify variants using DeepVariant, an artificial intelligence model developed by Google, and use the same reference genome (GRCh37) across all products.
• Complete traceability. Each report is linked to the software version, configuration, and data with which it was generated.
Where we stand today
Our software does not yet have CE-IVD marking, but the technical documentation is very advanced. We anticipate obtaining it in March 2027, barring any delays.
To meet this timeline, we have contracted BSI's Dedicated modality, the enhanced service of this notified body: a product expert assigned to our file and a pre-agreed review schedule (more about BSI's service).
|
Milestone |
Status as of October 2026 |
|
Notified Body |
BSI, Dedicated modality; contract signed in September 2026 |
|
Assessment applications (IVDR and ISO 13485) |
Opened with BSI in September 2026; kick-off meeting in October |
|
Manufacturer license before AEMPS |
Applied for in September 2026 |
|
Technical documentation |
Very advanced; submission to BSI in late 2026 |
|
Software validation |
Ongoing |
|
CE-IVD marking |
Anticipated for March 2027, barring delays |
The final date also depends on BSI's evaluation. If it changes, we will report it here.
What it means for you
Your experience with tellmeGen remains the same: you order your kit, take your buccal swab sample at home, and receive your results in your private area. What changes is everything behind the scenes:
• Greater rigor in every report. Each result with a health purpose will be supported by a documented evaluation of its scientific evidence and performance, reviewed by BSI.
• Honest information. We explain what each result means and also what it does not mean. A predictive report is not a diagnosis: if a result worries you, the appropriate step is to speak with a healthcare professional.
• People behind the data. Our Genetics team reviews the processes and is available to help you understand your results. In Spain, each report is reviewed individually before publication, and the consultation with a geneticist after the results is free of charge.
• Your data, protected. Information security is part of the evaluation. If you want to know more, read how we protect your genetic data.
• A product that improves over time. Post-market surveillance obliges us to review and update reports as science advances.
A high bar for the entire sector
We believe that any company offering genetic tests in Europe should follow this path. It is demanding and takes time, but it is the best guarantee for anyone entrusting their DNA to a company. We have decided to do it thoroughly and talk about it.
Science that can be verified
We have been analyzing DNA for over ten years. The road to CE-IVD is the way to demonstrate, before an independent evaluator, that we do it with the rigor required by European medicine. It is more work and more time. We believe it is what anyone who entrusts us with their genetic information deserves.
If you want to discover your genetics with a team that works this way, explore our Starter, Advanced, and Ultra (WGS 30x) tests. And if you want to learn more about how we work, consult our quality policy and our informed consent.
We will continue telling you every step of the way.
