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) · Spain
Jurisdiction
Spain
Regulation
Category
Type · Breadth
Date
AEPD analysis of data quality, accuracy and minimisation in processing by AI systems
The Spanish Data Protection Authority examines GDPR compliance requirements for data quality, accuracy and minimisation in AI-based processing.
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) · SpainEuropean Data Protection Board approves guidelines on personal data processing via blockchain
The EDPB has approved guidelines on the processing of personal data through blockchain technology.
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) · 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) · SpainAEPD reopens registration for public network of research groups and projects on privacy and emerging technologies
Leer más
AEPD (Spanish Data Protection Agency) · SpainAEPD and AESIA address institutional coordination on data protection and artificial intelligence
Leer más
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) · SpainLorenzo Cotino: "AI governance requires the involvement of all institutions and a special commitment from companies"
Leer más
AEPD (Spanish Data Protection Agency) · Spain
Showing 11 of 11 tracked updates
— health-tech relevant only. Show all health policy
See all in the feed →