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
Source
AEMPS (Spanish Medicine Agency)
Regulation
Category
Type · Breadth
Date
AEMPS 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) · 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) · 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) · 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 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) · 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) · 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: 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) · 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: 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 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 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: 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 alert: possible malfunction in insulin administration in certain serial numbers of t:slim X2 insulin pumps
A speaker defect in specific t:slim X2 insulin pump serial numbers may cause insulin administration to stop.
AEMPS (Spanish Medicine Agency) · SpainAEMPS Safety Alert: Medtronic Intelligent Glucose Monitoring Receiver – Preinstalled Applications Access Issue
Preinstalled Guardian, InPen and Simplera applications on Medtronic glucose monitoring receiver may fail to display startup screen due to software defect; device restart or technical support required.
AEMPS (Spanish Medicine Agency) · SpainAEMPS informs of withdrawal of equipment for HomeChoice Personal Cycler with cassette and 4 lines
Manufacturer identified increased alarm emissions in HomeChoice Personal Cycler with certain batches of cycler equipment with cassette and 4 lines.
AEMPS (Spanish Medicine Agency) · SpainAEMPS informs of possible manufacturing defect in Onli hydrophilic intermittent urethral catheter
AEMPS alerts to a localized protuberance approximately 2 cm from the drainage lumen in Onli hydrophilic intermittent urethral catheters, which may cause discomfort, genitourinary trauma or bleeding.
AEMPS (Spanish Medicine Agency) · SpainAEMPS Alert: Falsified CE Marking Certificate from Beijing Globalipl Development Co., Ltd
AEMPS warns of falsified CE marking certificate for medical laser equipment (intense pulsed light combined with laser devices) from Beijing Globalipl Development Co., Ltd.
AEMPS (Spanish Medicine Agency) · SpainAEMPS informs of fall risk in certain Winn'Motion hoists
Safety alert issued for Winn'Motion hoists due to identified fall risk.
AEMPS (Spanish Medicine Agency) · SpainAEMPS informs of market withdrawal of certain single-piece Guedel cannulas
AEMPS announces market withdrawal of specific single-piece Guedel cannulas for safety reasons.
AEMPS (Spanish Medicine Agency) · SpainAEMPS initiates therapeutic positioning reports for medicines with positive CHMP opinion from July meeting
AEMPS begins drafting therapeutic positioning reports for new medicines and new indications approved by CHMP in July.
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 CHMP in May.
AEMPS (Spanish Medicine Agency) · SpainCommittee for Medicinal Products for Human Use Bulletin, May 2026
Positive opinions issued for four new medicinal products: Boey, Etcamah, Jascayd, and Vijoice.
AEMPS (Spanish Medicine Agency) · SpainAEMPS informs of withdrawal of MediHoney products for wounds and burns
MediHoney wound and burn products withdrawn due to packaging defects compromising sterility, posing infection risk to patients.
AEMPS (Spanish Medicine Agency) · SpainHuman Medicines Committee Bulletin, June 2026
Positive opinions issued for new medicinal products including Onswik (insulin efsitora alfa) and Hopledo (levodopa/carbidopa).
AEMPS (Spanish Medicine Agency) · Spain
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