Compliance Checklist

CE Marking
Health & Medical
Spain 🇪🇸

CE marking for medical devices and health products on Amazon Spain: MDR requirements, risk classification, the new Spanish RECOPS register, and common mistakes.

Overview

Medical devices and health products in the EU are subject to the Medical Device Regulation (MDR) (EU) 2017/745 or the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 – unchanged in Spain as well. CE marking is mandatory for all medical devices. Spain has implemented these EU rules nationally through Real Decreto 192/2023: every economic operator placing medical devices on the Spanish market must register in the new Registro de comercializacion (RECOPS). RECOPS went live on 15 June 2026; anyone commercializing products since then has six months from the product's Eudamed notification to file the follow-up registration in RECOPS.

Does this apply to my product?

This checklist applies to all economic operators selling medical devices with a medical intended purpose to consumers in Spain via Amazon.es: blood pressure monitors, fever thermometers, blood glucose meters, pulse oximeters, wound care, orthopedic aids, compression stockings, medical masks, TENS devices, hearing aids, and in vitro diagnostics such as pregnancy or self-tests. The RECOPS registration obligation under Art. 18 RD 192/2023 (or Art. 15 RD 942/2025 for IVDs) explicitly covers every operator commercializing the products in Spain – not only manufacturers established in Spain.

Step-by-Step Guide

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Distinguish medical device vs. wellness product and determine risk class

The first decision is identical EU-wide: is the product a medical device within the meaning of the MDR, and if so, which risk class (I, IIa, IIb, III) does it fall into? This classification determines the entire certification process.

Estimated time: 1-2 Wochen / 1-2 weeks

Intended purpose defined and documentedRequired

A massage device 'for relaxation' is a wellness product (LVD/EMC Directive). The same device 'for treatment of muscle tension' is a medical device under MDR. Wording in the listing, packaging, and manual must be consistent.

Risk classification according to MDR Annex VIII completedRequired

Four risk classes: I (lowest risk), IIa (e.g. blood pressure monitors), IIb (e.g. ventilators), III (highest risk). The 22 classification rules in Annex VIII determine classification.

Classification report with justification of applied rules from MDR Annex VIII

Quality management system (QMS) and clinical evaluation

The MDR requires a complete QMS and clinical evaluation for all medical devices, including Class I – uniform across the EU.

Estimated time: 4-16 Wochen / 4-16 weeks

QMS according to EN ISO 13485:2016 implementedRequired

The QMS must cover design control, risk management, supplier evaluation, complaint handling, CAPA processes, and vigilance reporting.

QMS documentation according to EN ISO 13485

Clinical evaluation according to MDR Article 61 completedRequired

For Class I, a literature review and equivalence assessment is usually sufficient. From Class IIb onwards, clinical investigations may be required.

Clinical Evaluation Report (CER)

Create technical documentation according to MDR Annex II and III

The technical documentation must meet the requirements of MDR Annex II and III and, under MDR Art. 10(8), must remain available for at least 5 years – 15 years for implantable devices – after the last product is placed on the market.

Estimated time: 4-12 Wochen / 4-12 weeks

Technical documentation according to MDR Annex II compiledRequired

Product description, manufacturing information, general safety and performance requirements, risk management file, clinical evaluation, labeling, and instructions for use.

Complete technical documentation according to MDR Annex II

Post-Market Surveillance Plan (PMS Plan) createdRequired

Describes complaint tracking, vigilance reporting, and periodic safety update reports (PSUR from Class IIa).

Conformity assessment and Notified Body (from Class IIa)

From Class IIa onwards, involvement of an MDR-designated Notified Body is mandatory. Spain has its own MDR-designated Notified Body, ECM (Espacio Calidad Medicinal); alternatively, Notified Bodies from other EU states (TUeV SUeD, TUeV Rheinland, DEKRA, BSI) can also be engaged.

Estimated time: 4-26 Wochen / 4-26 weeks

Conformity assessment procedure selected and Notified Body engagedRequired

Check the NANDO database for which Notified Bodies are designated for your product category. Expect several months of lead time for the contract and first assessment.

EU Declaration of Conformity issued and CE marking affixedRequired

The DoC must reference all applied MDR Annexes, the Notified Body identification number (from Class IIa), and the UDI-DI.

EU Declaration of Conformity according to MDR Article 19

Registro de Comercializacion (RECOPS) with AEMPS

In addition to the European Eudamed registration, Spain requires under Art. 18 RD 192/2023 (Art. 15 RD 942/2025 for IVDs) that every commercialized product be reported in the national Registro de comercializacion. The new RECOPS application has been live since 15 June 2026; before that, reporting ran temporarily through the predecessor systems CCPS/RPS.

Estimated time: 1-4 Wochen / 1-4 weeks

After user registration in RECOPS, the economic operator declares the UDI-DI, the start date of commercialization in Spain, and the labeling and instructions for use for each product. The UDI-DI must first be notified and visible in Eudamed – RECOPS pulls the product data from Eudamed.

RECOPS declaration including UDI-DI, label, instructions for use

Maintain a traceability register of supplied recipientsRequired

Every economic operator commercializing products in Spain must keep a documented register ensuring traceability – including identification of supply recipients.

Distributors: activity notification to the competent Autonomous Community

Pure distributors additionally notify the start of their activity to the health authority of the Autonomous Community where their registered office is located – that authority also carries out oversight there.

Spanish labeling and Amazon.es listing compliance

Instructions for use and safety information must be provided in Spanish for the Spanish market. Amazon.es additionally requires the complete GPSR and compliance mandatory fields per ASIN.

Estimated time: 1-2 Wochen / 1-2 weeks

Instructions for Use (IFU) created in SpanishRequired

The IFU must meet the requirements of MDR Annex I Chapter III and be provided in Spanish. Symbols according to EN ISO 15223-1.

Category approval and GPSR mandatory fields in Amazon Seller CentralRequired

Medical devices on Amazon.es often require category approval (CE certificate, DoC, Notified Body certificate). Additionally, complete the GPSR mandatory fields (responsible person, manufacturer data).

Common Mistakes to Avoid

Wellness product falsely marketed as a medical device (or vice versa)

Consequence: A wellness product marketed with medical claims is legally considered an unauthorized medical device – fines and a sales ban may follow.

Prevention: Define the intended purpose before product development and keep all marketing materials, listings, and packaging consistent with it.

Missing the RECOPS filing after the 15 June 2026 system change

Consequence: Anyone who continues to report only under the old transitional procedure (CCPS/RPS) and ignores the new RECOPS obligation violates Art. 18 RD 192/2023 once the six-month follow-up deadline from Eudamed notification has expired.

Prevention: For every product commercialized since 15 June 2026, record the Eudamed notification date and submit the RECOPS filing within the six-month deadline.

Distributor mistakenly believes it is not subject to the RECOPS filing

Consequence: Art. 18 RD 192/2023 explicitly covers every economic operator commercializing products in Spain, not only the manufacturer. An Amazon seller distributing a foreign manufacturer's products in Spain is itself subject to the filing obligation.

Prevention: Before the first sale on Amazon.es, check whether a separate RECOPS filing as an economic operator is required – regardless of a Eudamed registration already made by the manufacturer.

Attempting the RECOPS filing without prior Eudamed notification of the product

Consequence: RECOPS pulls the product data directly from Eudamed – if the product is not notified and visible there, the Spanish filing cannot technically be completed.

Prevention: Follow the correct order: complete the product's Eudamed notification first, then carry out the RECOPS filing using the UDI-DI.

Instructions for use provided only in English or German

Consequence: Violation of the Spanish language requirement for consumer information. Amazon.es can suspend the listing, and competent authorities can intervene.

Prevention: Have the IFU, warnings, and packaging text professionally translated into Spanish before listing on Amazon.es.

Frequently Asked Questions

Q1What is RECOPS and since when has it applied?

RECOPS (Registro de comercializacion de productos sanitarios) is the new AEMPS application in which every economic operator commercializing medical devices in Spain must register. It has been live since 15 June 2026 and replaces the previous transitional procedures via CCPS/RPS (legal basis: Art. 18 RD 192/2023 or Art. 15 RD 942/2025 for IVDs).

Q2How much time do I have for the RECOPS filing?

Since 15 June 2026, a maximum period of six months from the product's Eudamed notification applies to complete the RECOPS filing.

Q3Do I need to register in RECOPS as a pure Amazon seller (distributor) even if the manufacturer is already registered in Eudamed?

Generally yes. Art. 18 RD 192/2023 requires a filing from every economic operator commercializing products in Spain, regardless of the manufacturer's registration. The manufacturer's Eudamed registration does not replace your own RECOPS filing.

Q4What was the legal situation before RECOPS, and does it still apply?

Until 15 June 2026, filings were made temporarily through the predecessor systems CCPS and RPS under the now-repealed Reales Decretos 1591/2009, 1662/2000 and 1616/2009. These systems are being phased out for new registrations; RPS remains active only for custom-made devices.

Q5Can SpaceGoats help me with medical device compliance for Amazon.es?

Yes, SpaceGoats offers support as an Amazon full-service provider for MDR compliance and coordinating Spanish RECOPS filings. Contact SpaceGoats at spacegoats.io for individual consulting.

CE MarkingHealth & MedicalSpain 🇪🇸