Explore the medical device requirements currently available for Portugal, organized by topic and linked to official sources.
Which claims, audiences, channels, approvals, and restrictions apply?
Advertising of medical devices remains governed by DL 145/2009 Chapter XIII (kept in force by DL 29/2024 art. 52(5) until a new advertising law is published), supplemented by the Código da Publicidade (DL 330/90); INFARMED is responsible for monitoring and enforcing device advertising.
Advertising to the general public is prohibited for devices whose use requires the mediation and decision of a health professional, notably implantable devices, long-term invasive devices, devices incorporating a medicinal substance or stable derivative of human blood/plasma, and devices manufactured using animal tissues.
What expires, what is retained periodically, and when must renewal start?
Notified bodies must apply to INFARMED for revaluation of their designation at least one year before the end of each five-year period counted from certification or recertification.
Effective from 2026-01-12
Technical documentation must be kept for 10 years after the start of use of the device and remain available for inspection; for implantable devices the period is 15 years.
Effective from 2024-07-04
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Distributors must transmit electronically to INFARMED changes and updates to the mandatory notification elements, including the date from which they ceased distributing a given device.
Effective from 2024-07-04
Which clinical or IVD performance evidence or study is required and accepted?
INFARMED is responsible for decisions on clinical investigation applications and notifications; the CEIC (Comissão de Ética para a Investigação Clínica) is the ethics committee competent for the ethics assessment under MDR Chapter VI and IVDR Chapter VI, and its opinion is binding and incorporated in the decision.
Effective from 2026-01-21
Clinical investigations of devices without CE marking, or CE-marked devices used outside the intended purpose, follow the MDR Art. 62 authorization regime; investigations of CE-marked devices within the intended purpose (participant inclusion not fixed by protocol, per Art. 40(2)) follow the MDR Art. 74 notification regime.
Effective from 2026-01-21
Clinical investigation applications/notifications are submitted through the EU electronic system of MDR Art. 73 or, for the national routes of Lei 71/2025 Art. 5, through INFARMED's national electronic system, with the full Annex XV Chapter II documentation; IVD performance study applications go through the IVDR Art. 69 system.
Effective from 2026-01-21
Is the product a device, IVD, accessory, software, or borderline product locally?
Devices manufactured and used in-house by health institutions under MDR Art. 5(5) must be notified to INFARMED electronically, with a declaration of GSPR compliance, exclusive internal use, QMS, updated technical documentation and justification that no equivalent CE-marked device meets the target patients' needs.
Effective from 2024-07-04
Which evidence, local deltas, formats, and signatures are required?
Documents, elements and information submitted to INFARMED (and to the authority responsible for notified bodies) under DL 29/2024 must be in Portuguese or accompanied by an official translation into Portuguese, unless expressly waived by INFARMED.
Effective from 2024-07-04
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
The exercise in Portugal of the activities referred to in MDR Article 16(2)(a) and (b) (activities that make the importer or distributor subject to manufacturer obligations) requires a communication to INFARMED; the communication terms are set by deliberation of the INFARMED board, and the applicant is responsible for the truthfulness and updating of the information submitted.
Effective from 2024-07-04
Which establishment licences, importer permissions, and distribution controls apply?
Distributors must comply with the good distribution practices of Portaria n.º 256/2016, de 28 de setembro (principles and norms of good distribution practice for medical devices); the same Portaria applies transitionally to wholesale distributors under DL 29/2024 art. 52(2)(c).
Effective from 2024-07-04
IVD wholesale distributors operating in the national market must communicate to INFARMED the IVDs they distribute, under the still-in-force Art. 12 of DL 189/2000 (name/address, list of products with brand/model, calibration documentation).
National manufacturers are exempt from the Art. 28 distribution notification for the devices they manufacture, provided they demonstrate compliance with MDR Article 31 (registration in EUDAMED).
Effective from 2024-07-04
Wholesale-type distribution activities in Portugal — supply, possession, storage or delivery of devices for resale or use in medical services, health units, pharmacies and other retail outlets (excluding supply to the public) — depend on prior notification to INFARMED.
Effective from 2024-07-04
Distributors must possess and keep records of all device transactions for five years.
Effective from 2024-07-04
Distribution activity is only permitted if the operator has a responsible technical person (responsável técnico) ensuring compliance and adequate facilities/equipment for storage, conservation and distribution.
Effective from 2024-07-04
What regulator fee applies to this class, route, event, and date?
Costs of acts and services of the competent authority and of the authority responsible for notified bodies (notifications, on-site visits and assessments, monitoring of notified bodies and their subcontractors) are charged to applicants; the fee table is set by portaria of the member of Government for health after hearing INFARMED.
Effective from 2024-07-04
Non-commercial clinical investigations and IVD performance studies, and studies where the sponsor is the investigator, are exempt from the INFARMED fees for investigation/performance study applications, notifications and substantial modifications.
Effective from 2026-01-21
Which label and IFU elements, languages, symbols, and translation controls apply?
INFARMED requires labels and instructions for use of IVDs to be written in Portuguese, legible and indelible, regardless of whether use is professional, without prejudice to other languages also being included.
Labelling, instructions for use, advertising material, implant card and other manufacturer information (including graphic interfaces) must be in Portuguese, without prejudice to including other languages, unless INFARMED waives Portuguese for specific device or user groups.
Effective from 2024-07-04
Which current law, regulation, guidance, and transition provisions apply?
Lei n.º 71/2025, de 22 de dezembro executes MDR Chapter VII (clinical investigations) and IVDR Chapter VI (performance studies) nationally: INFARMED decides, CEIC gives the binding ethics opinion, submissions go through the EU electronic system or INFARMED's national electronic system.
Effective from 2026-01-21
Decreto-Lei n.º 145/2009 is repealed by DL 29/2024, except provisions kept in force transitionally by Art. 52: arts 9, 10 and 11(1,2,3,5) and 41(1)(b) (registration duties until EUDAMED), Chapter XIII, 61(1)(mm)(nn) and 62 (advertising), and arts 66-68 (IVD, pending the IVDR execution law).
Effective from 2024-07-04
Until a national law executing Regulation (EU) 2017/746 is published, DL 145/2009 arts 66-68 remain in force for IVDs; DL 189/2000 (as amended) also remains the national IVD framework, and INFARMED applies DL 189/2000 art. 12 to IVD wholesale distributors.
Effective from 2024-07-04
Ellipsis marks omitted reference text. INFARMED's Registo de DM e DIV page (reviewed 2026-08-25) confirms DL 189/2000 art. 12 is 'ainda vigente' for IVD distributors.
Decreto-Lei n.º 29/2024, de 5 de abril (as amended by Decreto-Lei n.º 118/2025) ensures the execution of Regulation (EU) 2017/745 in the national legal order; it regulates economic operators, health institutions, notified bodies, vigilance, market surveillance and sanctions.
Effective from 2024-04-06
Published 2024-04-05; in force the next day; produces effects 90 days after publication (2024-07-04).
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
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 (Art. 84). Class I devices require a post-market surveillance report summarising results and conclusions (Art. 85); class IIa, IIb and III devices require a periodic safety update report (PSUR) per device or category, updated at least annually for class IIb and III devices and at least every two years for class IIa devices, forming part of the technical documentation (Art. 86).
Effective from 2021-05-26
Which current form, portal, account, and submission package must be used?
INFARMED operates SIDM (Sistema de Registo de Dispositivos Médicos), the national on-line registration system for devices and IVDs, articulated with EUDAMED to avoid duplicate registrations; completing a record with labelling, IFU and declaration automatically assigns the CDM (Código de Dispositivo Médico), published on the InfoDM public search portal; free-sale certificates are requested via SIDM.
Which QMS, audit, inspection, and certificate scope is accepted or required?
INFARMED supervises and inspects compliance with DL 29/2024, MDR and Implementing Regulation (EU) 2020/1207 across all establishments, institutions, units and sites in Portugal where device lifecycle activities are or may be carried out (design, manufacture, sterilisation, import/export, distribution, sale, use, installation, maintenance, consignment, loan, etc.).
Effective from 2024-07-04
Activities not liable to affect device conformity — sterilisation, maintenance, calibration, technical assistance or other services performed per manufacturer instructions — may only be carried out by entities with an implemented and maintained QMS, notably per EN ISO 13485.
Effective from 2024-07-04
Entities making devices available under loan or consignment must have an implemented QMS, notably per EN ISO 13485, proportionate to device risk class and type, plus qualified staff and a written contract with the user.
Effective from 2024-07-04
Which recall, FSCA, notice, and authority-coordination duties apply?
Until the EU implementing act under MDR Art. 91(d) is adopted, manufacturers must submit the field safety corrective action report and the safety notice to INFARMED up to two days before the date proposed for the start of the action, except in cases of serious public health threat.
Effective from 2024-07-04
To protect health, safety or MDR conformity, INFARMED may adopt necessary and transitional measures regarding a device or category of devices (including usage guidance and special monitoring); where non-conformities can be remedied, it may impose special conditions or duties and set a deadline for regularisation.
Effective from 2024-07-04
Which registration, notification, listing, reliance, or conformity route applies?
Any manufacturer domiciled or headquartered in Portugal placing custom-made devices on the market in its own name must notify INFARMED electronically.
Effective from 2024-07-04
Until EUDAMED is implemented and operational, manufacturers, authorised representatives, distributors and notified bodies must meet their national notification/registration duties under DL 145/2009 arts 9, 10, 11(1,2,3,5) (manufacturers/mandatários placing Class I, custom-made, sterilisation or procedure-pack devices) and 41(1)(b) (distributors); INFARMED operates the SIDM national registration system for this purpose.
Effective from 2024-07-04
INFARMED (Registo de DM e DIV page, reviewed 2026-08-25): 'Os fabricantes nacionais de Dispositivos Médicos Feitos por Medida (DMFM) continuarão a utilizar o SIDM para registo dos dispositivos que colocam no mercado, uma vez que não se encontra previsto o seu registo na EUDAMED.'
Which foreign decisions or evidence can be reused, with what effect and conditions?
Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.
Regulatory reference
A device registered, or approved for marketing and actually marketed, in a 'recognized state' (מדינה מוכרת) is registered in the Israeli register for a period not exceeding the period it may be marketed in that state, capped at 5 years from Israeli registration. Recognized states are listed in the First Addendum to the law — 21 states including the US, UK, Germany, France, Italy, Spain, the Netherlands, Belgium, Ireland, Denmark, Sweden, Finland, Norway, Iceland, Greece, Portugal, Austria, Switzerland, Australia, Canada and New Zealand (no single 'EU' entry: member states are listed individually).
First Addendum list per the official Sefer HaChukim text of the law held from gov.il.
Prior approval / evidence record
Class II, III and IV in-vitro diagnostic products already authorised and commercialised in countries regulated by PAHO/WHO reference regulatory authorities, by authorities of IMDRF Management Committee member countries, or by authorities with bilateral agreements with DINAVISA enter the Proceso Simplificado de Registro Sanitario (PSR). DINAVISA has 15 business days to validate and decide, and approval follows by positive silence if no report is issued.
PAHO/WHO reference regulatory authorities; authorities of IMDRF Management Committee member countries (the IMDRF committee includes US FDA, EU, Japan PMDA/MHLW, Health Canada, TGA, ANVISA, China NMPA, Korea MFDS, Singapore HSA and UK MHRA); authorities with bilateral agreements with DINAVISA
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2024-01-30
Source language: Spanish. Translation of the operative part of Art. 2: 'Applications for sanitary registration of In Vitro Diagnostic Products ... that are authorised and commercialised in countries regulated by: PAHO/WHO Reference Regulatory Authorities; Regulatory Authorities of member countries of the Committee of the International Medical Device Regulators Forum - IMDRF; Regulatory Authorities with which bilateral agreements with DINAVISA exist, shall be subject to the Simplified Sanitary Registration Process (PSR).' and 'DINAVISA shall have a term of 15 (fifteen) business days to validate the required documentation and decide thereon. Once the term has elapsed with no report from DINAVISA, the application shall be approved.' Article numbering confirmed by reading the page image of the official PDF.
Prior approval / evidence record
País de Alta Vigilancia Sanitaria (art. 9 D.S. 016-2011-SA): United States, Canada, Japan, Australia, Switzerland, South Korea, United Kingdom, Germany, France, Netherlands, Spain, Italy, Belgium, Portugal, Ireland, Austria, Hungary, Denmark, Norway, Sweden
Yes
The Peruvian route to relying on a foreign approval is documentary, not procedural. A certificate of free sale or a GMP certificate issued by a high-surveillance authority is accepted directly, and if the issuing authority appears on the Resolución Directoral 169-2014-DIGEMID list the document does not need an apostille. Everything else still goes through DIGEMID certification.
None published — the TUPA period is set by class, not by origin
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
FDA 510(k)/PMA
No
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
geo:prt
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
Decreto-Lei n.º 29/2024, as amended by Decreto-Lei n.º 118/2025, executes MDR in Portugal and gives INFARMED its mandate, the notification regimes and the language rules. Registration duties for IVDs additionally survive under the directive-era Decreto-Lei n.º 189/2000.
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
portugal
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
What review, validation, and applicant stop-clock rules apply?
For clinical investigation applications, the member state must notify the sponsor of the authorisation decision within 45 days of the validation date (Art. 70(5)), extendable by a further 20 days for the purpose of consulting with experts; once notified, and absent a negative ethics opinion valid for the entire member state, the sponsor may start the investigation with the devices referred to in the application.
Effective from 2021-05-26
The fixed statutory clock in the MDR is the clinical-investigation authorisation clock; no statutory review deadline is fixed for notified-body conformity assessment itself.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
Upon duly justified request, INFARMED may exceptionally authorise the placing on the market or putting into service in Portugal of specific devices that have not undergone the conformity assessment procedures, where use contributes to public health or patient safety/health; the request is submitted electronically.
Effective from 2024-07-04
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
Decisions on clinical investigation applications, notifications and substantial modifications may be challenged by administrative impugnation (hierarchical appeal to the member of Government responsible for health) and by judicial review under the general terms of law.
Effective from 2026-01-21
Decisions restricting, conditioning or prohibiting the placing on the market of devices must be reasoned and notified to addressees (to the registered e-mail address, per the Administrative Procedure Code); such decisions may be appealed under the general terms.
Effective from 2024-07-04
Which UDI, device listing, database, and traceability duties apply?
Distributors must electronically transmit to INFARMED, for coding and supervision purposes, their device list including the UDI-DI of implantable devices supplied (recording UDI-DI of other devices is possible), plus manufacturer/mandatário identification, labelling and IFU.
Effective from 2024-07-04
Any public or private entity using implantable devices must record and keep, preferably electronically, the unique identification of the implantable devices used or supplied to them.
Effective from 2024-07-04
Devices already registered in EUDAMED are recorded in SIDM using the EUDAMED data with the UDI-DI/EUDAMED ID; after upload of labelling, IFU and declaration the CDM device code is automatically assigned and the record becomes searchable in the public InfoDM portal.
What is reportable, by whom, where, in what format, and by what deadline?
Until the EUDAMED vigilance module is implemented, serious incidents and FSCA are reported to INFARMED using the EU harmonized forms published by the European Commission; all communication is by e-mail to dvps@infarmed.pt.
Health professionals (in or outside the SNS), other professional users and other interested parties must equally notify INFARMED of serious incidents they become aware of as soon as possible, without prejudice to also informing manufacturers, mandatários, importers and distributors.
Effective from 2024-07-04
The persons referred to in MDR Art. 22 must additionally communicate to INFARMED all information on suspicions of serious incidents occurring in Portugal after devices are placed on the market, including incidents involving or related to reprocessed single-use devices.
Effective from 2024-07-04
portugal:medical-device
portugal
EU MDR classes I, Is, Im, Ir, IIa, IIb and III
National projection of the directly applicable EU MDR classification. The canonical class axis and rules are maintained in eu:medical-device; national references describe only administration or local deltas.
i
Class I
low
is
Class Is
low
im
Class Im
low
ir
Class Ir
low
iia
Class IIa
medium
iib
Class IIb
high
iii
Class III
highest
INFARMED
official-source-verified
eu:medical-device
Regulation (EU) 2017/745, Art. 51 and Annex VIII
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-26
Portugal
portugal
PT
🇵🇹
National Authority of Medicines and Health Products
INFARMED
europe
3
4-class (I, IIa, IIb, III) — EU MDR
class-i
Class I
low
Self-declaration (no notified body)
0
0
days
official-verified
EUR-Lex Regulation (EU) 2017/745 (MDR)
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-25
6
9
months
No
No
Yes
FDA 510(k)/PMA
No
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file
Yes
EU Authorized Representative
No
ISO 13485 accepted as QMS evidence
5 years (CE certificate)
2026-08-29
partially-verified
Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)
https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj
2027-02-25
2026-08-29
EUR-Lex Regulation (EU) 2017/745 (MDR)
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-25
EUR-Lex MDR consolidated text — Annex IX §5.1 (expert-panel clinical evaluation consultation: 21/60 days) and §5.2(d) (ancillary medicinal-substance opinion: 210 days)
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0745-20250110
2026-08-29
2026-08-29
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by INFARMED. Appoint a EU Authorized Representative.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to INFARMED including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
INFARMED reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. INFARMED may issue questions.
0 days
⚙️
5
Registration Approval
Upon successful review, INFARMED issues Portugal market authorization certificate.
1-2 weeks
✅
portugal
Portugal
PT
INFARMED
200
200
EUR
No
1000
1000
EUR
No
clinical-study-application-non-ce
Clinical-study application - non-CE device or CE outside intended purpose
EUR
1000
EUR 1,000
Per application
exact-current
official-verified
https://www.infarmed.pt/documents/15786/17838/portaria_n_63_2015.pdf
Portugal Portaria 63/2015: clinical-study fees in force until 5 November 2026
2015-03-01
2026-08-25
clinical-study-application-ce
Clinical-study application - CE-marked device
EUR
600
EUR 600
Per application
exact-current
official-verified
https://www.infarmed.pt/documents/15786/17838/portaria_n_63_2015.pdf
Portugal Portaria 63/2015: clinical-study fees in force until 5 November 2026
2015-03-01
2026-08-25
study-notification-non-ce
Study notification - non-CE device
EUR
600
EUR 600
Per notification
exact-current
official-verified
https://www.infarmed.pt/documents/15786/17838/portaria_n_63_2015.pdf
Portugal Portaria 63/2015: clinical-study fees in force until 5 November 2026
2015-03-01
2026-08-25
study-notification-ce
Study notification - CE-marked device
EUR
400
EUR 400
Per notification
exact-current
official-verified
https://www.infarmed.pt/documents/15786/17838/portaria_n_63_2015.pdf
Portugal Portaria 63/2015: clinical-study fees in force until 5 November 2026
2015-03-01
2026-08-25
protocol-amendment
Study protocol amendment
EUR
200
EUR 200
Per amendment
exact-current
official-verified
https://www.infarmed.pt/documents/15786/17838/portaria_n_63_2015.pdf
Portugal Portaria 63/2015: clinical-study fees in force until 5 November 2026
2015-03-01
2026-08-25
2026-08-25
official-verified
Portugal Portaria 63/2015: clinical-study fees in force until 5 November 2026
https://www.infarmed.pt/documents/15786/17838/portaria_n_63_2015.pdf
2015-03-01
2026-08-25
Portugal Portaria 327/2026/1: device clinical-investigation fees
https://files.diariodarepublica.pt/1s/2026/08/15100/0004100043.pdf
2026-11-06
2026-08-25
2026-08-25
exact-current
Yes
portugal
Portugal
high
lvd-medical-exclusion-mdr-electrical-safety
MDR electrical safety in place of the Low Voltage Directive
Medical Electrical Safety
Included In Medical Registration
Finished Device
Annex II of Directive 2014/35/EU places electrical equipment for radiology and medical purposes outside the Low Voltage Directive, so there is no separate national electrical-safety certificate for a medical device. Electrical safety is assessed inside the MDR conformity assessment against MDR Annex I, with the harmonised IEC/EN 60601 series carrying the presumption of conformity.
candidate
emc-directive-disapplied-by-mdr
MDR electromagnetic compatibility in place of the EMC Directive
emc
Included In Medical Registration
Finished Device
Article 2(3) of Directive 2014/30/EU switches the EMC Directive off where other Union legislation lays the same essential requirements down more specifically, which MDR Annex I sections 18.5 and 18.6 do for medical devices. EMC is therefore dossier evidence inside the CE route and not a separate national EMC conformity step.
candidate
dl-57-2017-radio-market-access
Decreto-Lei 57/2017 radio equipment market access
Radio Spectrum
Mandatory If Feature
Radio Equipment
Article 7 of Decreto-Lei 57/2017 of 9 June, in its consolidated version, allows only radio equipment complying with the decree to be made available on the market, article 10 guarantees free circulation of compliant equipment, and article 39 gives surveillance to ANACOM and ASAE. A full read of the consolidated text found no Portuguese type approval, homologation or pre-market authorisation. Article 8(2) lets ANACOM add requirements for entry into service or use on spectrum-efficiency, interference and public-health grounds, which is the verbatim RED article 7(2) power and a use condition rather than a product approval.
candidate
dl-79-2013-rohs-substance-restriction
Decreto-Lei 79/2013 substance restriction (RoHS)
Environmental And Batteries
Evidence Only No Separate Certificate
Electrical Electronic Medical Device
Portugal transposed Directive 2011/65/EU by Decreto-Lei 79/2013 of 11 June, published in Diário da República 111/2013 Series I, with a subsequent declaração de retificação, as recorded on the EUR-Lex national implementing measures page. The Portuguese text itself was not opened, so no article number is given and the designated competent authority is not confirmed from the decree. Directive 2011/65/EU Annex I category 8 covers medical devices, Article 4(3) has bound medical devices since 22 July 2014 and in vitro diagnostic medical devices since 22 July 2016, and Article 2(4)(h) excludes active implantable medical devices.
candidate
dl-152-d-2017-unilex-market-precondition
UNILEX producer-responsibility system as a precondition for market placement
Environmental And Batteries
Mandatory Pre Market
Producer Or Authorised Representative
Article 7(2) of Decreto-Lei 152-D/2017, the unified regime for specific waste streams, permits placing and making available on the national market only products whose producers have adopted one of the producer-responsibility systems set out in article 7(1), and article 19(1) requires producers to report to APA through the integrated electronic waste registration system. That system is SIRER, operated by APA as national waste authority under articles 95 to 97 of Decreto-Lei 102-D/2020 and regulated by Portaria 20/2022, and is reached through the SILiAmb platform. Directive 2012/19/EU Article 2(4)(g) excludes devices expected to be infective before end of life and active implantable devices; other medical devices are in scope, and Article 16 requires each Member State to keep a producer register.
candidate
sirer-battery-producer-registration
Battery producer registration in SIRER under Article 55
Environmental And Batteries
Mandatory Pre Market
Battery Producer Or Authorised Representative
APA's own January 2026 producer-registration briefing states that a producer that is not registered, or whose authorised representative for extended producer responsibility is not, may not place batteries on the market, and that Article 55(1) of Regulation (EU) 2023/1542 is discharged through the existing SIRER producer register in SILiAmb. The same document carries an important negative: the batteries-specific sanctions regime is still being drafted, so for the producer register the prohibitions and penalties of UNILEX and the RGGR continue to apply and there is no batteries-specific Portuguese implementing decree. Article 11(2)(b) of Regulation (EU) 2023/1542 lets professional medical imaging and radiotherapy devices and in vitro diagnostic medical devices restrict portable-battery replacement to independent professionals, and Article 11(3) lifts the removability duty where continuity of supply is needed for safety or data integrity.
unresolved
apa-radiation-practice-licence-or-registration
APA radiation practice licence or registration
Ionizing Radiation
Mandatory If Feature
Radiation Source Import Or Practice
Decreto-Lei n.º 108/2018 art. 22(2) subjects the operation of intraoral dental equipment and bone densitometry equipment to registration, and art. 22(4) subjects to licensing the operation of ionising radiation generators, accelerators (other than electron microscopes) and radioactive sources both for medical and non-medical imaging exposures and for other purposes, and — in art. 22(4)(i) — the import, export and introduction of radiation sources into national territory. The Agência Portuguesa do Ambiente is the competent authority for licensing and registration, holders of sealed sources or equipment incorporating them file the Annex IV standardised registration sheet in advance and report receipt within 10 days, and the art. 188 fee is fixed by Portaria n.º 293/2019.
candidate
EUR-Lex
Low Voltage Directive 2014/35/EU Annex II — electrical equipment for radiology and medical purposes outside scope
https://eur-lex.europa.eu/eli/dir/2014/35/oj
EUR-Lex
EMC Directive 2014/30/EU Article 2(3) — more specific Union legislation displaces the directive
https://eur-lex.europa.eu/eli/dir/2014/30/oj
EUR-Lex
RoHS Directive 2011/65/EU Annex I category 8 and Article 4(3) medical-device application dates
https://eur-lex.europa.eu/eli/dir/2011/65/oj
EUR-Lex
WEEE Directive 2012/19/EU Article 2(4)(g) medical-device exclusions and Article 16 national producer register
https://eur-lex.europa.eu/eli/dir/2012/19/oj
EUR-Lex
Batteries Regulation (EU) 2023/1542 Articles 11 and 55 — medical-device removability derogation and producer register
https://eur-lex.europa.eu/eli/reg/2023/1542/oj
Diário da República Eletrónico
Decreto-Lei 57/2017 arts. 7, 8, 10 and 39 — consolidated RED regime
https://diariodarepublica.pt/dr/legislacao-consolidada/decreto-lei/2017-156850835
Diário da República Eletrónico
Decreto-Lei 152-D/2017 arts. 7 and 19 — UNILEX market precondition and APA electronic registration
https://diariodarepublica.pt/dr/detalhe/decreto-lei/152-d-2017-114337042
APA (Agência Portuguesa do Ambiente)
Registo de Produtores — Baterias, 30 January 2026: Article 55 discharged through SIRER and the pending sanctions regime
https://apambiente.pt/sites/default/files/_Residuos/FluxosEspecificosResiduos/Produtores/Apresentacoes/registo-de-produtores_bat30.01.2026.pdf
Diário da República
Decreto-Lei n.º 108/2018 — prior administrative control of radiation practices
https://diariodarepublica.pt/dr/detalhe/decreto-lei/108-2018-117202785
Agência Portuguesa do Ambiente
consolidated radiation protection legislation and APA licensing instruments
https://apambiente.pt/prevencao-e-gestao-de-riscos/legislacao-2
