Spain medical device registration timeline
Source-linked clocksSpanish Agency of Medicines and Medical Devices (AEMPS) review clocks and end-to-end planning ranges, using the 4-class (I, IIa, IIb, III) — EU MDR classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Class I(Self-declaration (no notified body)) MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock | 0 days | 6-9 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesSpain Medical Device Registration Process
Step-by-step AEMPS registration process. Total estimated timeline: 6-9 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by AEMPS. Appoint a EU Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to AEMPS including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksAEMPS reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. AEMPS may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, AEMPS issues Spain market authorization certificate.
- EU Authorized Representative (for non-EU manufacturers)
- Clinical investigation: 10-day validation, 45-day evaluation (+20 with experts)
- Establishment licence (companies) resolved within 3 months; licence valid 5 years
Reviewed 2026-08-29. End-to-end totals remain planning estimates.