Faster Market Entry Through Integrated IVDR and WHO Strategy
Faster Market Entry Through Integrated IVDR and WHO Strategy
Global in vitro diagnostics (IVD) manufacturer
Clinical
.png?width=146&height=108&name=IVD%20(2).png)
In vitro Diagnostics
Share
\
\
X (Twitter) 
\
\
LinkedIn 
\
\
WhatsApp 
\
\
Copy link 
\
\
Mail
A pioneering in vitro diagnostics (IVD) company focused on point-of-care molecular testing. Known for its diverse portfolio, the company develops rapid diagnostic tools that support real-time, accurate decision-making in clinical practice. From infectious diseases to genetic disorders and oncology, their solutions are designed to improve patient outcomes across a range of healthcare settings.
1
Challenge
2
Approach
3
Result
Challenge
The client aimed to launch a Class D diagnostic test-suitable for professional, near-patient, and self-testing - in the European market under IVDR while simultaneously pursuing WHO prequalification.
Navigating these two regulatory frameworks posed significant challenges around complexity, timelines, and sample volume requirements.
Approach
To tackle this, we designed an integrated strategy that combined IVDR and WHO requirements to avoid duplication and minimize the total sample size.
Our team managed four tailored studies:
- A combined clinical performance study
- Near-patient and self-test studies for IVDR
- Separate self-test study for WHO prequalification.
Serving as the client’s legal representative, we facilitated smooth ethical and regulatory approvals. From study setup to site coordination and ongoing communication with authorities, we provided full project management to keep everything on track.
Result
This first-time-right strategy enabled the client to meet both IVDR and WHO requirements simultaneously, reducing sample needs and accelerating timelines.
The efficient approach saved costs and cut time to market, earning praise for our expertise and practical solutions. This success also paved the way for ongoing collaboration on multiple additional products.
Get in touch
Looking to fast-track market access with a smart regulatory approach?
Our experts are here to help you navigate IVDR and WHO requirements. Fill in the form, and we’ll be in touch soon!
First name*
Last name*
Professional Email*
Company name*
Role*
Please SelectC-level / VPDirector(Sr.) ManagerSpecialist/AnalystIntern/ApprenticeIndividual contributorOther
Department*
Please SelectStrategy & ManagementRegulatory & VigilanceQuality Assurance & ControlIT & Digital InnovationManufacturing & ProductionProduct DevelopmentResearch & InnovationClinical Affairs & OperationsMedical AffairsMarket AccessSales & MarketingHRProcurementOther
(Mobile) phone number
Country*
Please SelectAfghanistanÅland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAsia/Pacific RegionAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBoliviaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCaribbean NetherlandsCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCongoCook IslandsCosta RicaCote d'IvoireCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the CongoDenmarkDjiboutiDominicaDominican RepublicEast TimorEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaEuropeFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern and Antarctic LandsGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacauMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmar (Burma)NamibiaNauruNepalNetherlandsNetherlands AntillesNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalauPalestinePanamaPapua New GuineaParaguayPeruPhilippinesPitcairn IslandsPolandPortugalPuerto RicoQatarRéunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint MartinSaint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSint MaartenSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia and the South Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluU.S. Virgin IslandsUgandaUkraineUnited Arab EmiratesUnited KingdomUnited StatesUnited States Minor Outlying IslandsUruguayUzbekistanVanuatuVatican CityVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabwe
Industry *
Please SelectMedical DevicesIn Vitro DiagnosticsPharmaBiotechAnimal HealthService providerConsumer HealthOther
Question submitted*
Field of Interest at time of last SRA
Content Title
Content Type
Content Division
QbD Group is committed to protecting and respecting your privacy, and we’ll use your personal information to administer your account and to provide the products and services you requested from us.
-
Yes, I want to stay informed on the latest industry trends and updates
-
I consent to the privacy policy and understand that my personal data will be stored and processed *