Quality & accreditation

European lab. Audited standards. Nothing improvised.

Every badge on our site points here. Below is what ISO 15189, RvA, MDR 2017/745, IVDR 2017/746 and the GDPR actually mean for the sample you post back to us and the numbers you read afterwards.

ISO 15189RvA / DAkkSMDR 2017/745IVDR 2017/746GDPR
Interior of the ISO 15189-accredited partner laboratory that analyses Haylo samples

From your kitchen table to a released result

  1. 1. Kit dispatched

    Sealed MDR-compliant collection device, lot number recorded against your order.

  2. 2. Sample collected

    You collect at home and post it back in the prepaid, tracked return envelope.

  3. 3. Logged at the lab

    Barcode scanned on arrival, condition and temperature checked before analysis.

  4. 4. Analysed and released

    CE-marked IVD assays under ISO 15189, results released with reference intervals.

ISO 15189

ISO 15189 — medical laboratory quality and competence

ISO 15189 is the international standard written specifically for medical laboratories. It covers how a lab is run and how each individual test is validated: staff competence, equipment calibration, sample handling, reference ranges, turnaround times and how results are reported. Our partner lab is assessed against this standard, which means every Haylo panel is analysed under the same regime a hospital laboratory works under.

  • Every analyser is calibrated and verified against certified reference material
  • Internal quality controls run alongside your sample on every batch
  • External proficiency testing compares the lab's results with other accredited labs
  • Result reports state the method and reference interval used
RvA / DAkkS

RvA accreditation — the independent auditor behind the badge

A standard only means something if somebody checks it. The RvA (Raad voor Accreditatie) is the Dutch national accreditation body, and DAkkS is its German counterpart. Both are signatories to the European and international mutual recognition agreements, so their accreditation is accepted across the EU. They audit the lab on site, review records, observe staff and can suspend the scope of accreditation if anything falls short.

  • On-site audits on a fixed cycle, plus unannounced checks
  • Accreditation is granted per test method, not per laboratory as a whole
  • Findings must be closed out with evidence before accreditation continues
MDR 2017/745

MDR — the collection device that arrives at your door

The device you use to collect your sample at home is a medical device. It is CE-marked under the EU Medical Device Regulation 2017/745, which governs its design, biocompatibility, clinical evaluation, sterile packaging, instructions for use and post-market surveillance. That is why the kit arrives sealed, with a lot number and an expiry date printed on it.

  • CE mark under MDR 2017/745 with a named legal manufacturer
  • Sterile, single-use collection components with lot traceability
  • Reported incidents are handled under formal vigilance procedures
IVDR 2017/746

IVDR — the assays that read your blood

Each assay used to measure a biomarker is an in-vitro diagnostic. Under the EU In Vitro Diagnostic Regulation 2017/746, assays carry a CE mark supported by analytical and clinical performance evidence: how precise they are, how they behave at low concentrations, how they compare against reference methods. Haylo does not invent its own measurements — we use CE-marked IVDs run by the accredited lab.

  • Documented analytical performance for every marker on your panel
  • Validated for the capillary sample type your kit collects
  • Performance is monitored after launch, not just at approval
GDPR

GDPR — your results are health data, treated as such

Blood results are special-category personal data under the GDPR. They are stored encrypted on infrastructure inside the European Union, access is limited to the people who need it to deliver your result, and they are never sold or shared with advertisers. You can request an export or deletion of your data at any time.

  • Encrypted at rest and in transit, hosted in the EU
  • No sale or advertising use of health data, ever
  • Export or erase your data on request

Haylo provides testing, analysis and supplement and lifestyle education. We do not diagnose, prescribe or treat. Accreditation and CE marking apply to the partner laboratory, the collection device and the assays used, as described above.

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