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 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) · 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) · SpainBulletin on the Safety of Human Medicines. July 2026
Monthly bulletin reporting new safety information from periodic pharmacovigilance data evaluation and AEMPS-authorised risk-prevention communications.
AEMPS (Spanish Medicine 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) · SpainBulletin on the Safety of Human Medicines. June 2026
Monthly safety bulletin reporting periodic pharmacovigilance data evaluation and AEMPS-authorised risk-prevention information materials.
AEMPS (Spanish Medicine Agency) · SpainBulletin on the Safety of Human Medicines. May 2026
Monthly bulletin reporting new safety information from periodic pharmacovigilance data evaluation and AEMPS-authorised risk-prevention materials.
AEMPS (Spanish Medicine Agency) · SpainBulletin on the Safety of Human Medicines, April 2026
Monthly safety bulletin reporting periodic pharmacovigilance data evaluation, authorised risk-prevention information, and other relevant safety matters.
AEMPS (Spanish Medicine Agency) · SpainAEMPS notification of entry into force of Implementing Regulation (EU) 2024/1973 on the use of certain antimicrobials in animals
Implementing Regulation (EU) 2024/1973 on antimicrobial use in animals enters into force on 8 August 2026.
AEMPS (Spanish Medicine Agency) · SpainEU expands fragrance allergens requiring labelling in cosmetics from 24 to 81
EU regulation expands fragrance allergens requiring individual labelling on cosmetic products from 24 to 81, effective August 2026.
AEMPS (Spanish Medicine Agency) · SpainAEMPS guidance on correct use of skin disinfectants
AEMPS publishes infographic guidance on appropriate and inappropriate uses of TP1 biocides for human hygiene.
AEMPS (Spanish Medicine Agency) · SpainAEMPS information on microplastics restriction and implications for biocidal products under its remit
Regulation 2023/2055 restricts marketing of products containing intentionally added microplastics; member state authorities agree this applies to AEMPS-regulated biocides.
AEMPS (Spanish Medicine Agency) · SpainAEMPS publishes guidance on simplified special registration applications for veterinary medicines
Guidance on the procedure, requirements and application form for simplified special registration of eligible veterinary medicines.
AEMPS (Spanish Medicine Agency) · SpainEuropean Commission publishes recommendations on identifying when cascade prescribing of veterinary medicines is justified
Guidance clarifies that authorised veterinary medicines do not automatically exclude cascade prescribing for a given species and indication.
AEMPS (Spanish Medicine Agency) · SpainBulletin on the Safety of Human Medicinal Products, July 2025
Monthly safety bulletin reporting periodic pharmacovigilance data evaluation and AEMPS-authorised risk-prevention information for human medicines.
AEMPS (Spanish Medicine 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) · SpainAEMPS informs on prohibition of cosmetic products containing TPO
Prohibition on use and marketing of cosmetic products containing Trimethylbenzoyl Diphenylphosphine Oxide (TPO) entered into force on 1 September 2025.
AEMPS (Spanish Medicine Agency) · SpainAEPD to participate in XX STIC Conference with data protection session
(2 de septiembre de 2026). La Agencia Española de Protección de Datos (AEPD) participará en lavigésima edición de las Jornadas STIC, que se celebrarán del 24 al 27 de noviembre de 2026 en Kinépolis Ciudad de la Imagen...
AEPD (Spanish Data Protection Agency) · SpainAEPD Privacy Lab invites submission of projects, research and initiatives
El Laboratorio de Privacidad de la Agencia Española de Protección de Datos (AEPD) mantiene abierto su espacio deNovedades, una iniciativa destinada adar visibilidad a publicaciones, investigaciones, proyectos, convoca...
AEPD (Spanish Data Protection Agency) · SpainLorenzo Cotino: "AI governance requires the involvement of all institutions and a special commitment from companies"
(15 de julio de 2026). La Agencia Española de Protección de Datos (AEPD) ha inaugurado hoy el curso‘Protección de datos en la empresa y las organizaciones: gobierno corporativo, gestión del riesgo y cumplimiento ante ...
AEPD (Spanish Data Protection Agency) · SpainAEMPS: Monovalent veterinary vaccines against IBR, PIF and rabies require OBPR certificate before release and marketing in Spain
Monovalent veterinary vaccines against IBR, PIF and rabies must obtain an OBPR certificate before release and marketing in Spain from 1 November 2026.
AEMPS (Spanish Medicine Agency) · SpainAEMPS ceases issuing decision communications for IA/IAin variations in European procedures where it acts as Concerned Member State
AEMPS will no longer issue decision communications for IA/IAin variations in European procedures; the Reference Member State is responsible for notifying the marketing authorisation holder.
AEMPS (Spanish Medicine Agency) · SpainAEMPS collaborates with Ghana's regulatory agency to strengthen capacity for biological medicine evaluation
AEMPS sends expert delegation to Ghana to provide training on European pharmaceutical regulation and evaluation institutions.
AEMPS (Spanish Medicine Agency) · SpainAEMPS awards fifth PRAN Prizes 2026 to nine antimicrobial resistance initiatives
Spanish medicines agency announces winners of annual awards recognising excellence and innovation in antimicrobial resistance.
AEMPS (Spanish Medicine Agency) · SpainAntibiotic consumption in Spain resumes downward trend, falling nearly 19% since 2015
Systemic antibiotic consumption in human health in Spain fell 5.1% in 2026 compared to 2024, the largest annual decline since before the COVID-19 pandemic.
AEMPS (Spanish Medicine Agency) · SpainAEPD announces Data Protection Awards 2026 to recognise commitment to promotion and dissemination of this right
(Madrid, 27 de julio de 2026). La Agencia Española de Protección de Datos (AEPD) ha convocado los‘Premios Protección de Datos Personales 2026’, que incluyen las siguientes categorías: Investigación en Ciencias Puras y...
AEPD (Spanish Data Protection Agency) · SpainAEMPS becomes first European agency to participate in international internship programme with Pan American Health Organization
Generar PDF Fecha de publicación: 27 de julio de 2026 Categoría: la AEMPS Referencia: AEMPS, 17/2026 El programa, que cuenta con el apoyo del Banco Interamericano de Desarrollo (BID), busca crear un puente de intercam...
AEMPS (Spanish Medicine Agency) · SpainAEMPS initiates therapeutic positioning reports for medicines with positive CHMP opinion from June meeting
AEMPS begins drafting therapeutic positioning reports for new medicines and new indications approved by CHMP in June.
AEMPS (Spanish Medicine Agency) · SpainAEMPS initiates therapeutic positioning reports for medicines with positive CHMP opinion from May meeting
AEMPS begins drafting therapeutic positioning reports for new medicines and new indications approved by the CHMP in May.
AEMPS (Spanish Medicine Agency) · SpainAEMPS participates in Vac-Med project to strengthen regulatory capacity in Latin America and the Caribbean
AEMPS delegation met with regional authorities in Dominican Republic to discuss biosimilar medicines regulatory framework.
AEMPS (Spanish Medicine Agency) · SpainAEMPS Bulletin on Cosmetics, Biocides and Personal Care Products, April–June 2026
Fecha de publicación: 27 de julio de 2026NIPO: 134-24-003-7 Productos cosméticos Legislación Vigilancia y control Otra información de interés Biocidas AEMPS y productos de cuidado personal Legislación Vigilancia y con...
AEMPS (Spanish Medicine Agency) · SpainHuman Medicines Committee meeting, July 2026
Generar PDF Fecha de publicación: 24 de julio de 2026 Categoría: medicamentos de uso humano Referencia: MUH (CMH), 07/2026 En esta nota informativa se enumeran los nuevos medicamentos de los que el CMH informó favorab...
AEMPS (Spanish Medicine Agency) · SpainAEMPS Committee for Medicinal Products for Human Use: June 2026 meeting
Generar PDF Fecha de publicación: 22 de julio de 2026 Categoría: medicamentos de uso humano Referencia: MUH (CMH), 06/2026 En esta nota informativa se enumeran los nuevos medicamentos de los que el CMH informó favorab...
AEMPS (Spanish Medicine Agency) · SpainAEMPS and Plena Inclusión Madrid launch easy-read guide to promote safe sun exposure
AEMPS publishes easy-read guidance on sun protection recommendations in collaboration with Plena Inclusión Madrid.
AEMPS (Spanish Medicine Agency) · SpainCommittee for Medicinal Products for Veterinary Use: July 2026 meeting
Generar PDF Fecha de publicación: 21 de julio de 2026 Categoría: medicamentos veterinarios, CODEM VET Referencia: MVET (CODEM VET) 07/2026 En esta nota se enumeran los nuevos medicamentos veterinarios de los que el CO...
AEMPS (Spanish Medicine Agency) · SpainBulletin on Veterinary Medicines, April–June 2026
Generar PDF Fecha de publicación: 21 de julio de 2026 NIPO: 134-24-004-2 El 54º Boletín sobre Medicamentos Veterinarios de los meses de abril, mayo y junio de 2026, publicado por la Agencia Española de Medicamentos y ...
AEMPS (Spanish Medicine Agency) · SpainAEMPS Committee on Veterinary Medicinal Products: June 2026 meeting
Generar PDF Fecha de publicación: 21 de julio de 2026 Categoría: medicamentos veterinarios, CODEM VET Referencia: MVET (CODEM VET) 06/2026 En esta nota se enumeran los nuevos medicamentos veterinarios de los que el CO...
AEMPS (Spanish Medicine Agency) · SpainAEMPS Safety Alert: Unauthorized access risk in Albert e-motion M25 wheelchair drive system
Manufacturer reports two cybersecurity attack attempts on Albert e-motion M25 wheelchair system; no risk materialised; additional security measures implemented.
AEMPS (Spanish Medicine Agency) · SpainAEMPS Safety Alert: Possible battery internal fixation failure in TD Navio Midi and TD Navio Maxi augmentative and alternative communication devices
Manufacturer identified potential battery internal fixation defect in TD Navio Midi and Maxi devices; internal components may fail under strong impact or mechanical stress.
AEMPS (Spanish Medicine Agency) · SpainAEMPS alerts to possible malfunction in MiniMed Go diabetes app affecting nocturnal alert functionality
AEMPS reports a potential defect in the MiniMed Go diabetes application affecting the operation of nocturnal alerts.
AEMPS (Spanish Medicine Agency) · SpainAEMPS alert: possible internal electrical component failure in certain Astral 100 and Astral 150 ventilators
Internal electrical component failure in Astral 100 and Astral 150 ventilators manufactured before October 2024 may interrupt therapy delivery.
AEMPS (Spanish Medicine Agency) · SpainAEMPS Alert: Theft and illegal distribution of two batches of Dexcom G7 sensors
Two batches of Dexcom G7 continuous glucose monitoring sensors (1725204004 and 1725069002) were stolen and illegally distributed by unauthorised third parties; batches were discarded by manufacturer due to inadequate sterilisation.
AEMPS (Spanish Medicine Agency) · SpainAEMPS Alert: Software Error in Dexcom G6 iOS Application Versions 1.11.2 and 1.12.0
Dexcom G6 iOS app versions 1.11.2 and 1.12.0 may malfunction and display outdated glucose readings instead of current values.
AEMPS (Spanish Medicine Agency) · SpainAEMPS Safety Alert: Defect in Newport HT70 Plus Ventilators and PCBA Replacement Parts
Newport HT70 Plus ventilators may shut down during use or fail to activate shutdown alarm; AEMPS issues recommendations for patients, caregivers, healthcare professionals and distributors.
AEMPS (Spanish Medicine Agency) · Spain
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