TypeAllBlog & InsightsCase studiesEvents & ConferencesIVD NewsRegulatory UpdatesWhitepapers
SectorAllDigital Health & AIIVDsLaboratoriesMedical DevicesPrecision Medicine & CDx
New Regulation on In Vitro Diagnostic Medical Devices in Spain: Are You Ready?

New Regulation on In Vitro Diagnostic Medical Devices in Spain: Are You Ready?
02.06.2023
IVD News, Regulatory Updates | IVDs, Laboratories
Impact of Spain’s Real Decreto 192/2023 on Clinical Investigations with Medical Devices

Impact of Spain’s Real Decreto 192/2023 on Clinical Investigations with Medical Devices
22.04.2023
Regulatory Updates | Medical Devices
EU Q&A Guide: Amendments to MDR and IVDR Transitional Provisions

EU Q&A Guide: Amendments to MDR and IVDR Transitional Provisions
27.03.2023
Regulatory Updates | IVDs, Medical Devices
IVDR technical documentation guidance released by Team-NB (updated 2026)

IVDR technical documentation guidance released by Team-NB (updated 2026)
13.03.2023
Regulatory Updates | IVDs
Position Paper on Cyber Security: What EU Notified Bodies Expect from Medical Device Manufacturers

Position Paper on Cyber Security: What EU Notified Bodies Expect from Medical Device Manufacturers
13.10.2022
Regulatory Updates | Digital Health & AI
Data produced by ‘Off-Label’ Device Use in accordance with EU Medical Device Regulation 2017/745

Data produced by ‘Off-Label’ Device Use in accordance with EU Medical Device Regulation 2017/745
13.10.2022
Regulatory Updates | Medical Devices
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