The Spanish Agency of Medicines and Medical Devices (AEMPS) has published a new note enabling a transitional procedure for healthcare institutions to submit the prior notification required for the in-house manufacture of IVDs, as set out in Article 9.8 of Royal Decree 942/2025.
Until the dedicated electronic application becomes available, notifications may be submitted through a web-based form, together with the public declaration required under Article 5.5(f) of Regulation (EU) 2017/746 (IVDR).
Key takeaways:
- The procedure is intended to support compliance while avoiding unnecessary administrative burden
- The current legal requirements remain fully applicable until any future amendment to the IVDR is formally adopted
- AEMPS recommends that healthcare laboratories start the process of accreditation to ISO 15189 in preparation for compliance with the applicable requirements
This publication is particularly relevant for healthcare institutions and laboratories involved in in-house IVD manufacturing in Spain, as it provides practical guidance on how to proceed during this interim period.
Have a look at the complete new here: https://www.aemps.gob.es/informa/la-aemps-habilita-el-procedimiento-para-realizar-la-comunicacion-previa-de-la-fabricacion-in-house-de-productos-sanitarios-para-diagnostico-in-vitro/
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