Eu Mdr Medical Device Compliance Registration Service In Spain

Scope and evidence must be confirmed before any paid tests or filings.

For an EU MDR medical device intended for sale in Spain, 'registration' is not a single product licence. The execution file normally has an EU layer (economic-operator identification and manufacturer device data in EUDAMED) and a Spanish commercialisation layer (the relevant economic operator's communication in AEMPS RECOPS). An AEMPS operating licence may be a separate prerequisite for specified activities. Confirm the intended purpose, MDR versus IVDR, classification, CE conformity route and each actor's real supply-chain function before opening a filing.

As of 28 May 2026 the EUDAMED Actor, UDI/Devices, Notified Bodies & Certificates and Market Surveillance modules are mandatory for their respective users, subject to transitional provisions. Spain launched RECOPS on 15 June 2026. EUDAMED registration, a RECOPS notification and notified-body certification are different acts; none of the registry acknowledgements substitutes for MDR conformity or permission to sell a non-compliant device.

Select the correct filing before you pay

Record / authority	Who acts and what is submitted	Practical gate
EUDAMED actor / competent authority	Manufacturer, authorised representative, importer and system/procedure-pack producer register in their appropriate roles; actor ID/SRN follows competent-authority validation. A non-EU manufacturer supplies an active EU representative and mandate summary.	The competent authority depends on the actor/representative establishment; Spain is not automatically the authority for every Spain-bound device.
EUDAMED UDI/Devices / EU	Manufacturer registers applicable regulation device data, including Basic UDI-DI, UDI-DI and EMDN; verify device and certification links.	Product entry requires valid actor access and coherent identifiers; it is not an upload of the entire Annex II/III technical file.
Notified body / conformity assessment	Where the MDR conformity route requires a notified body, that body performs the assessment and enters applicable certificate records in EUDAMED.	Neither an SRN nor RECOPS replaces CE conformity or a required notified-body certificate.
RECOPS / AEMPS Spain	Each economic operator actually commercialising covered non-custom-made devices in Spain normally makes its own communication by product UDI-DI: company, EUDAMED-derived device record, real Spanish start date, labels and instructions for use.	A device must be visible in EUDAMED for RECOPS selection; an authorised representative may act under documented delegation in applicable scenarios.
RPS / AEMPS Spain	Separate Spanish route for custom-made-device manufacturers placing such devices on the market and authorised representatives established in Spain as applicable.	Do not put custom-made devices into the ordinary RECOPS UDI-DI workflow.
Operating licence / AEMPS Spain	Spanish manufacturing, importing, grouping or sterilisation activities may require a prior AEMPS establishment licence under Royal Decree 192/2023, distinct from registrations.	Check actual activities and establishment, including physical importation; a distributor label alone is not a legal determination.
Regional distribution/activity notice / Autonomous Community	Spanish distributors and sellers generally notify the health authority of the Autonomous Community of their registered office and, if in another Community, their warehouse location before starting the activity.	Separate from RECOPS. Under Royal Decree 192/2023, Article 24(4), pharmacies and other exclusively public-facing retail outlets are excepted from the distributor RECOPS communication; assess the real activity before using this exception.

RECOPS applicant exceptions need evidence, not just an invoice chain. The AEMPS FAQ gives examples in which one entity of a corporate group files for its group, or a non-Spain-established actor operates exclusively through other actors also not established in Spain; assess the precise functions and contracts before treating any participant as exempt. A non-EU manufacturer's delegation to its authorised representative should be documented by a signed agreement. Sharing labels/IFU with another company in RECOPS is only a document association, not an exemption from a separate communication.

Do not combine the two retail exemptions. Under Royal Decree 192/2023 Article 24(3), pharmacies are also excepted from the prior notification of public-sale activity, unless they perform Article 26 activities; other retail-only outlets are not automatically exempt from the Article 24(3) activity notice simply because Article 24(4) exempts them from RECOPS. Retail premises supplying devices requiring individual adaptation may need prior regional authorisation under Article 26. Verify the exact activity before opening or dispensing.

Physical import is its own licensing gate: Article 28(2)(a) requires the Spanish establishment carrying out physical importation from a third country to hold the Article 7 operating licence, even where that entity is not the MDR-defined importer. An exceptional AEMPS authorisation may be possible under Article 28(5), but cannot be presumed. Check shipment origin and actual importer of record before arranging customs entry.

Assemble the filing packet, not a generic technical dossier

Operator map: legal names, registered locations, supply path, actual manufacturer, EU authorised representative, importers, distributors and which entity first commercialises in Spain.
Regulatory basis: intended purpose, MDR qualification, risk class, conformity route, EU declaration of conformity, applicable certificate and validity; flag IVDR and custom-made exclusions.
EUDAMED actor access: SRN/Actor ID or application status, designated users, signed information-security declaration and, for a non-EU manufacturer, representative mandate summary.
Device identifiers: Basic UDI-DI, UDI-DI for each marketed device, EMDN, model/trade name, certificate links and evidence that the EUDAMED record is visible.
Spain materials: actual first marketing date, final Spanish-market labels and instructions for use or documented justification if instructions are legitimately absent.
RECOPS credentials, designated corporate user, earlier CCPS/RPS communication reference where applicable and any documented delegation or association for shared labels.
Separate licence evidence if manufacture, import, grouping or sterilisation is performed in Spain; keep technical documentation, clinical evidence, PMS and traceability records available without assuming they are all uploaded into RECOPS.
For Spanish distribution or sales, collect regional start-of-activity notification details, registered-office and warehouse locations and the basis for any retail exception; verify the intended-use information required on putting the device into service is available at least in Castilian (Royal Decree 192/2023, Article 5(2)).

Submit in dependency order

Confirm device status and map every economic operator; stop if classification, conformity or the Spanish commercialiser is unresolved.
If required, secure the appropriate AEMPS operating licence and notified-body conformity route; these are independent workstreams, not downstream effects of RECOPS.
Register the required actors in EUDAMED; resolve representative validation and competent-authority queries and preserve the SRN and access approvals.
Manufacturer publishes the correct applicable device/UDI record in EUDAMED; reconcile product, certificate, class and the intended regulatory regime.
Each obligated commercialiser creates its own RECOPS company/user access, selects the visible UDI-DI, attaches Spanish-market labels/IFU, enters the actual first marketing date, checks any old reference and pays the calculated fee where due.
Archive submission/communication IDs, payment evidence, EUDAMED extracts and correspondence; allocate an owner for future updates and AEMPS queries.

Before Spanish distribution or sale begins, check the separate notification to the relevant Autonomous Community, including any warehouse in a different Community; RECOPS is not a substitute for this activity notice.

Apply the 2026 transition without false shortcuts

For products already recorded in EUDAMED before 28 May 2026, AEMPS identifies a maximum six-month RECOPS transition calculated from 28 May 2026. For products recorded after that date, its FAQ calls for communication when recorded and visible, generally before a new Spanish launch; verify the specific historical and launch facts.

Earlier CCPS/RPS communications do not migrate automatically. The old references may support exemption from the RECOPS initial fee where the same company previously communicated the product; annual maintenance and other fees must be checked separately.

AEMPS states that where the product is not yet visible in EUDAMED, RECOPS filing is technically unavailable and explains a conditional ability to continue commercialising such products. This is not a waiver of mandatory EUDAMED registration, CE conformity, licence or other marketing requirements. Check the separate EUDAMED legacy-device transition; a qualifying pre-28-May-2026 device may have a 28 November 2026 registration deadline.

Treat the six-month RECOPS deadline for products registered in EUDAMED before 28 May 2026 and the EUDAMED UDI/Device transitional deadline for qualifying pre-mandatory-market devices as different tests. Neither is a general deferral for a newly launched device.

Resolve the failures that actually block a filing

Wrong filer: a Spanish buyer assumes the non-EU manufacturer’s SRN or another distributor’s RECOPS entry covers its own commercial activity; map each actor and check AEMPS exceptions, group arrangements and documented delegation.
Not found in RECOPS: confirm visibility and correct regulatory record in EUDAMED, check an existing RECOPS draft or communication, and escalate to AEMPS ServiceDesk if still absent more than 48 hours after EUDAMED visibility.
UDI mismatch: package UDI-DIs are not normally separate RECOPS product communications; file the product UDI-DI and include labels/IFU for packaging formats actually commercialised.
Outdated documents or links: provide actual Spain-market labelling/IFU and publicly accessible document links without authentication; correct product/manufacturer/certificate master data first in EUDAMED.
Legacy transfer or payment error: re-enter old CCPS/RPS notifications in RECOPS, preserve same-company previous references where fee relief applies and do not treat a paid draft as final submission.
Batch constraint: RECOPS permits up to 1,000 product UDI-DIs per draft only when they share the marketing-start date and labelling/IFU conditions; each product UDI-DI nevertheless generates its own communication and applicable fee. Confirm draft status and payment validation rather than resubmitting blindly.

Maintain the registration after the first submission

Manufacturer corrects changed EUDAMED device/master and certificate information at its source; RECOPS synchronises corresponding fields, while the RECOPS company owner manages Spanish labelling, IFU, company data and communications.
RECOPS communications remain subject to an annual maintenance charge and payment management; AEMPS warns that unpaid maintenance can cause automatic deactivation. Monitor the coordinator’s notices and the applicable account period.
If shared documentation through a RECOPS company association is withdrawn, missing labels/IFU can lead to automatic deactivation after the 21-day remediation period identified by AEMPS. Keep replacement files and direct access.
Maintain the MDR post-market surveillance, vigilance, traceability and conformity obligations outside the mere fact of registration; re-check new UDI-DIs, changed commercialisers or cessation of activity.
Article 18(3) and (5) of Royal Decree 192/2023 separately require notification of changes or cessation and an annual update identifying products still commercialised; failure to update can remove entries. AEMPS states the first annual maintenance fee is due in the year after the company’s first RECOPS communication, with a 30-day payment window on notification; missed payment also results in automatic deactivation.

The RECOPS annual maintenance fee is paid once yearly for the company, regardless of how many product communications were made or when, while the amount is calculated using the communications and applicable volume reductions; this is separate from the initial fee for each communication and from the annual Article 18(5) product-status update. Confirm the payable sum in RECOPS rather than multiplying an unadjusted headline rate.

Scope a filing-execution engagement

An execution mandate should specify separately: actor/SRN submission assistance, manufacturer UDI/Device registration, RECOPS notifications for named Spanish commercialisers, possible RPS/operating-licence work and responses to authority requests. The filing party retains its legal responsibilities; a service provider does not become manufacturer or authorised representative just by preparing screens.

Useful handover evidence is a role-and-device matrix, checked source data, approved draft, submission IDs, EUDAMED/RECOPS status screenshots or exports, fee receipts and an outstanding-actions register. A successful registration is not a promise of notified-body approval, CE certification or market access.

For classification and conformity strategy, see EU MDR compliance consulting.
For broader Spanish CE execution, see CE marking services in Spain.
For EU-wide filing mechanics, see EU MDR registration service.

Specific filing questions

Does RECOPS replace EUDAMED for Spanish sales?

No. EUDAMED records actors/devices at EU level; RECOPS records the Spanish economic operators and the non-custom-made devices they commercialise. The product normally needs an EUDAMED record visible to RECOPS.

Our manufacturer already filed RECOPS: must our distributor file too?

Generally each commercialising agent files its own communication. AEMPS describes exceptions and group/delegation scenarios; determine the actual supply arrangement instead of relying solely on another company’s filing.

Can we reuse a 2025 CCPS communication in RECOPS?

Not automatically. A new RECOPS communication is needed. The old number can support relief from the initial fee where AEMPS conditions, including same-company responsibility, are met.

What if our UDI-DI is not searchable in RECOPS?

Check that the correct regulation/legacy record is visible in EUDAMED, then whether it was already notified or drafted in RECOPS. If still missing after more than 48 hours, raise a technical ticket with AEMPS ServiceDesk; do not invent a replacement identifier.

Are custom-made devices or IVDs filed in the same place?

Custom-made medical devices follow the Spanish RPS route described by AEMPS; other MDR devices use RECOPS. IVDs are governed by IVDR and the Spanish regime for IVDs, although RECOPS also covers non-custom-made IVD marketing communications.

Do pharmacies and retail-only shops need their own RECOPS communication?

Article 24(4) of Royal Decree 192/2023 excepts pharmacies and other outlets selling exclusively to the public from the distributor RECOPS communication. The exception does not automatically apply to wholesale/distribution activities, or remove traceability and other applicable obligations.