Bulletin on Medical Devices. April–June 2026
Bulletin implementing EU Regulation 2026/977 establishing uniform quality management and conformity assessment procedure requirements for medical devices.
AEMPS (Spanish Medicine Agency) · SpainSpain
Regulation
Category
Type
Date
AEPD analysis of data quality, accuracy and minimisation in personal data processing with AI systems
Spanish DPA publishes technical guidance on how GDPR principles of accuracy and data minimisation apply to personal data processing incorporating artificial intelligence systems.
AEPD (Spanish Data Protection Agency) · SpainIberoamerican Network approves reference document on enhanced safeguards required for neurodata processing in non-health settings
The Iberoamerican Network of Data Protection Authorities has approved a reference document establishing enhanced safeguards for processing neurodata outside healthcare contexts.
AEPD (Spanish Data Protection Agency) · SpainAEMPS enables procedure for prior notification of in-house manufacture of in vitro diagnostic devices
AEMPS establishes a procedure for healthcare centres to submit prior notifications of in-house IVD manufacture pending the specific electronic application.
AEMPS (Spanish Medicine Agency) · SpainEMA and HMA open comment period on new EU-IN guidance for investigators
EMA and HMA invite comments on new EU-IN guidance describing scientific and regulatory support tools available nationally and at EU level for medicine and technology development.
AEMPS (Spanish Medicine Agency) · SpainEuropean Data Protection Board adopts Guidelines on processing personal data through blockchain technologies
EDPB adopts guidelines on GDPR compliance for personal data processing via blockchain, addressing privacy protection in distributed ledger environments.
AEPD (Spanish Data Protection Agency) · SpainAEPD promotes common compliance model in public sector with recommendations and next actions
Spanish data protection agency publishes GDPR compliance recommendations for public administration, developed through dialogue with data protection officers.
AEPD (Spanish Data Protection Agency) · SpainAEMPS validates governance model and action plan for implementing the health technology assessment regulation
AEMPS establishes governance structure and implementation roadmap for coordinated application of the new European HTA framework.
AEMPS (Spanish Medicine Agency) · SpainAEPD reopens registration for public network of research groups and projects on privacy and emerging technologies
Spanish Data Protection Agency reopens registration for its public research network on privacy and emerging technologies, welcoming research groups and individual researchers.
AEPD (Spanish Data Protection Agency) · SpainAEPD and AESIA address institutional coordination on data protection and artificial intelligence
Spanish data protection and AI supervision agencies meet to discuss collaboration on data protection in AI projects, including regulatory sandboxes.
AEPD (Spanish Data Protection Agency) · SpainAEMPS announces new Health Technology Assessment System following Royal Decree 415/2026 approval
AEMPS will serve as Medicine Evaluation Office and participate in governance of new Health Technology Assessment System aligned with EU Regulation 2021/2282.
AEMPS (Spanish Medicine Agency) · SpainSpain: pioneer in EU elimination of paper package inserts for hospital medicines
AEMPS expands paperless hospital-medicine project to 656 national codes (17% of hospital medicines marketed in Spain), with authorized information accessible digitally.
AEMPS (Spanish Medicine Agency) · Spain
Showing 12 of 12 tracked updates
— health-tech relevant only. Show all health policy