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AEMPS · Europe

Spain medical device regulatory resources

Every Spain dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

5 free resources24/25 requirements coveredAug 2026 fees reviewed
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Medical device regulation news

Follow recent Spanish Agency for Medicines and Medical Devices (AEMPS) policy, guidance, safety, and compliance updates.

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Describe your device and get a preliminary AEMPS risk class with official rule references.

Government registration fees

Review current AEMPS application, review, and renewal fees.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Spain requirements.

Registration timeline

Compare the statutory notified-body conformity assessment clock under Regulation (EU) 2026/977 with realistic CE marking times by device class.

Structured regulatory requirements

Explore all 44 source-linked facts →

24 of 25 research dimensions currently covered · 21 official sources · latest verification 2026-09-07

Market entry

D01

Authority & regime

Verified
Regional (comunidades autónomas) competences
Spanish regional health authorities (comunidades autónomas) grant the operating licence for custom made device manufacturing, receive the prior start of activity communication from distribu…
Competent authority
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS; Spanish Agency of Medicines and Medical Devices) is the competent authority for medical devices for the purposes of Article 1…
2 source-linked facts
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
National medical-device decree (RD 192/2023)
Real Decreto 192/2023, de 21 de marzo, por el que se regulan los productos sanitarios is the Spanish national decree developing the member state options of Regulation (EU) 2017/745; it dero…
National IVD decree (RD 942/2025)
Real Decreto 942/2025, de 21 de octubre, por el que se regulan los productos sanitarios para diagnóstico in vitro is the Spanish national decree complementing Regulation (EU) 2017/746 (comp…
4 source-linked facts
Checked 2026-08-25
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D03

Device definition & scope

Verified
AEMPS decides definition/borderline questions
AEMPS decides on the application to a product of the definitions and classification criteria of Regulation (EU) 2017/745 (Articles 2 and 51.2 and Annex VIII), and may consult the Comité de…
1 source-linked fact
Checked 2026-08-25
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D04

Classification rules

Verified
EU MDR classes I, Is, Im, Ir, IIa, IIb and III
Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III
1 maintained scheme
Checked 2026-08-26
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D05

Registration pathways

Verified
RECOPS deadline after EUDAMED notification
Economic operators commercializing products in Spain must make the communication to RECOPS within no more than six months from the product's notification to EUDAMED; the product must be not…
Custom-made devices: RPS and Registro de Responsables
Custom made device manufacturers established in Spain must be entered in the AEMPS Registro de Responsables (communication listing products manufactured and, for class III implantable custo…
3 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
EU CE under MDR/IVDR — single market validity
target: geo:esp · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · loc…
1 source-linked fact
Checked 2026-08-30
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D07

Economic-operator roles

Verified
National import licence
An import licence from AEMPS is required both for importers established in Spain and for persons that physically introduce products into Spain without being the importer under the EU Regula…
Distributor start-of-activity communication to the region
Distributors and sellers of devices established in Spain must make a prior start of activity communication to the health authority of the comunidad autónoma of their registered office (and…
2 source-linked facts
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
AEMPS prior operating licence
Persons engaged in manufacture, import, grouping (agrupación) or sterilisation of medical devices require a prior operating licence (licencia previa de funcionamiento) granted by AEMPS; the…
Prescription devices and sale restrictions
Spain defines nationally which devices are subject to prescription (custom made devices, serial products with written prescription, SNS funded products, individually adapted products, and p…
2 source-linked facts
Checked 2026-08-25
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D09

Dossier requirements

Verified
Technical documentation (Annexes II and III)
The technical documentation required to demonstrate conformity with the general safety and performance requirements must be drawn up in accordance with Annex II to Regulation (EU) 2017/745…
1 source-linked fact
Checked 2026-08-29
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D10

Official forms & portals

Verified
RECOPS portal and closure of CCPS/RPS
RECOPS is the AEMPS electronic application (via AEMPS sede electrónica) for the commercialization registration of devices other than custom made and of IVDs; from 28 May 2026 no new communi…
Clinical-investigation submission channel
Clinical investigation authorization applications are made by written request of the sponsor to the Director of AEMPS and, until the EUDAMED electronic system is available, are submitted th…
2 source-linked facts
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Spanish-language requirement for devices
At the moment of putting into service in Spain, medical devices must include the data and information of section 23 of Annex I to Regulation (EU) 2017/745 at least in Spanish (castellano),…
Importer/distributor duty to verify Spanish labelling
Importers and distributors must ensure that devices are accompanied by the Spanish language data and information, both on the labelling and in the instructions for use, as required by RD 19…
4 source-linked facts
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
Establishment-licence quality requirements
To obtain the AEMPS operating licence, establishments must have a quality management system able to guarantee product quality, adequate installations/equipment/personnel, and a responsible…
1 source-linked fact
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Verified
MDR electrical safety in place of the Low Voltage Directive
Electrical safety
MDR electromagnetic compatibility in place of the EMC Directive
EMC
RD 188/2016 radio equipment and the CNAF use condition
Wireless / radio
8 maintained overlays
Checked 2026-09-07
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D14

Fees

Verified
Registration/communication of medical devices (code 5.01)
EUR 99.71
Prior operating licence - manufacturing, sterilisation, reprocessing establishments (code 5.17)
EUR 983.85
10 maintained fee lines · 1 related fact
Checked 2026-08-25
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D15

Review clocks

Unresolved
Class I · Self-declaration (no notified body)
0 days
1 maintained pathway · 2 related facts
Checked 2026-08-29
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D16

Approval validity & renewal

Verified
Operating-licence validity
Operating licences have a validity period not exceeding five years, renewable on request after verification of compliance; any modification of the conditions under which the licence was gra…
Annual update of the Registro de comercialización
Economic operators must annually update their communication to the Registro de comercialización stating the products they continue to commercialize; failure to update causes removal (baja)…
2 source-linked facts
Checked 2026-08-25
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Lifecycle & post-market

D17

Change control

Verified
Change control: licences and registro data
Any modification of the conditions under which an operating licence was granted must be previously authorized by the body that granted it (AEMPS or the region); any change of the data commu…
1 source-linked fact
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
Official UDI or listing surface
submissionSurface: EUDAMED (UDI/device registration) plus national RECOPS commercialization registration from 15 June 2026 · verifiedHighlights: RECOPS requires the product to be notified a…
1 source-linked fact
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Clinical investigation: AEMPS authorization and CEIm opinion
The sponsor applies to AEMPS for clinical investigation authorization (application, investigator's brochure, plan, informed consent and investigational device labelling/instructions at leas…
Clinical-investigation insurance minimums
The sponsor of a clinical investigation must take out insurance or a financial guarantee covering the liability of investigators and sponsor; the minimum coverage is EUR 250,000 per subject…
4 source-linked facts
Checked 2026-08-25
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D20

Special access & derogation

Verified
Hospital in-house manufacture (MDR Art. 5(5) national rule)
Only hospitals may manufacture devices for their own exclusive use, complying with MDR Art. 5(5); class IIb, class III and implantable devices may not be manufactured by hospitals; hospital…
1 source-linked fact
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
Post-market surveillance reporting (Arts. 83-86)
Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device…
1 source-linked fact
Checked 2026-08-29
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D22

Vigilance & incident reporting

Verified
National serious-incident reporting by professionals and patients
Healthcare professionals and authorities who become aware of a serious incident in the course of their activity must notify AEMPS through its electronic office (portal NotificaPS); the regi…
Manufacturer/economic-operator notification channel
Companies (manufacturers and other economic operators) notify incidents and field safety corrective actions to AEMPS using the notification forms of the Spanish device vigilance guidelines…
2 source-linked facts
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
FSCA prior notice to AEMPS and Spanish safety note
Manufacturers must inform AEMPS of any field safety corrective action before the action is carried out (per MDR arts. 87.1 and 88), and the safety note must be sent to AEMPS before its diff…
Market-surveillance inspection basis
AEMPS and Spanish administrations exercise market surveillance and inspection over devices per Articles 108.2 and 108.3 of the consolidated Law of guarantees and rational use of medicines a…
2 source-linked facts
Checked 2026-08-25
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D24

Advertising, claims & promotion

Verified
Ban on public advertising of SNS-funded devices
Manufacturers, distributors, marketers and any entities in direct contact with patients may not engage in direct or indirect advertising to the general public of a medical device that is fu…
Prior authorization of public advertising by regional authorities
Advertising messages inserted in general media (including the Internet) and any other promotional material directed at the public are subject to prior authorization by the health authoritie…
3 source-linked facts
Checked 2026-08-25
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D25

Submission communications & appeal

Verified
AEMPS resolutions end the administrative route
Resolutions of AEMPS in the licence procedures of RD 192/2023 end the administrative route (ponen fin a la vía administrativa), so no ordinary administrative appeal (recurso de alzada) lies…
1 source-linked fact
Checked 2026-08-25
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Government fees

Full fee schedule (10 lines) →

AEMPS registration fees in EUR · reviewed 2026-08-25

Fee lineAmountProvenance
Registration/communication of medical devices (code 5.01)EUR 99.71Verified
Prior operating licence - manufacturing, sterilisation, reprocessing establishments (code 5.17)EUR 983.85Verified
Manufacturing-licence modification/revalidation (code 5.19)EUR 983.85Verified
Prior operating licence - import and grouping establishments (code 5.18)EUR 491.92Verified
6 more fee lines on the full schedule · 10 of 10 rows source-verified

Registration timeline

Full registration timeline →

Spanish Agency of Medicines and Medical Devices (AEMPS) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — EU MDR classification

Class / pathwayReview clockPlanning totalProvenance
Class I(Self-declaration (no notified body))0 days6-9 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(0 days)
  5. 5Registration Approval(1-2 weeks)

Latest regulation news

All Spain regulation news →

Newest official AEMPS headlines from the daily-refreshed feed — every row links directly to the authority publication.

Sep 4SASpanish Agency for Medicines and Medical Devices (AEMPS)AEMPS Reports a Fault in Certain Newport HT70 Plus Ventilators and PCBA Replacement PartsSpainSep 3SASpanish Agency for Medicines and Medical Devices (AEMPS)AEMPS Reports Risk of Unauthorized Access in the Alber e-motion M25 Wheelchair Add-On Drive SystemSpainAug 27SASpanish Agency for Medicines and Medical Devices (AEMPS)AEMPS Reports Potential Manufacturing Defect in Onli Hydrophilic Intermittent Urethral CathetersSpainAug 27SASpanish Agency for Medicines and Medical Devices (AEMPS)AEMPS Warns of Potential Battery Fastening Failure in TD Navio Midi and Maxi Communication DevicesSpainAug 5SASpanish Agency for Medicines and Medical Devices (AEMPS)AEMPS Alerts on Possible Electrical Component Failure in Astral 100/150 VentilatorsSpain
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