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) · SpainAEMPS (Spanish Medicine Agency)
Regulation
Category
Type
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) · SpainEMA and HMA open comment period on new EU-IN guidance for investigators
EMA and HMA invite comments on updated EU-IN guidance describing scientific and regulatory support tools available nationally and at EU level for medicine and technology development.
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) · 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 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) · Spain
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