Clinical Investigation of Medical Devices in Spain – AEMPS Oversight

Legal Framework

Clinical investigations of medical devices in Spain are governed by Regulation (EU) 2017/745 (MDR), Articles 62-82, and national implementing legislation. AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) is the competent authority responsible for assessing and authorising clinical investigations, ensuring compliance with ethical standards, participant protection, and scientific validity. The framework applies to all investigational devices intended to generate clinical data for conformity assessment, performance evaluation, or post-market follow-up. Investigación clínica - Productos sanitarios - AEMPS

Scope and Classification of Investigations

• Article 62 investigations: Interventional clinical performance studies or studies with additional invasive or burdensome procedures require AEMPS authorisation.
• Other studies: Non-interventional or low-intervention studies may follow a lighter notification procedure.
• Higher-risk devices (Class IIb implantable, Class III, active implantable) and certain Class IIa devices typically require full assessment.

Application Process

Sponsors submit applications via the national portal, including:

• Clinical investigation plan
• Investigator's brochure
• Risk-benefit analysis
• Ethics committee opinion
• Informed consent forms
• Insurance coverage for participants

AEMPS evaluates scientific and ethical aspects, often in parallel with ethics committee review. Authorisation is granted within statutory timelines (typically 60 days, extendable).

Conduct and Reporting Obligations

• Investigations must follow ISO 14155 (Good Clinical Practice for medical devices).
• Substantial modifications require prior AEMPS approval.
• Sponsors report serious adverse events, device deficiencies, and urgent safety measures promptly.
• Annual progress reports and final study reports are submitted to AEMPS.

Post-Investigation and Data Use

Data from authorised investigations support CE marking applications or post-market clinical follow-up. AEMPS monitors compliance through inspections and may suspend or terminate studies if safety concerns arise.

This structured process balances innovation with rigorous protection of trial participants while aligning with EU harmonised requirements. Detailed guidance, forms, and fees are published on the AEMPS website. Investigación clínica - Productos sanitarios - AEMPS