Medical Device - Portugal

The English web pages contain selected items from its Portuguese language site and will be continuously expanded.

Medical Devices (MD): Application must be submitted on RNEC (https://www.rnec.pt/pt_PT) and it should follow the list of requirements on the National Ethics Committee page (https://www.ceic.pt/documentos-submissao). The platform does not support further communications, which will be received by e-mail from clinicalstudies.devices@infarmed.pt.

In-Vitro Diagnostics Medical Devices (IVD): Application must be submitted via e-mail to clinicalstudies.devices@infarmed.pt. There is no national submission requirements list, at the moment, but recommendations on MDCG guidelines should be followed (https://health.ec.europa.eu/document/download/4e1f946d-a71a-42c7-bd98-0e9977752669_en?filename=mdcg_2022-19_en.pdf). Applicants are advised to check the requirements for MDs in terms of language, to follow those directions for common documents.

Combined Studies: In case of a Clinical Trial combined with a IVD performance study or MD clinical investigation, the Clinical Trial must be submitted on CTIS and the other study, in parallel, following the directions mentioned above.

As a Member-State, in Portugal, European Regulations 2017/745 (MDR) and 2017/746 (IVDR) apply directly. National Laws apply only on topics not covered by the Regulation, or if the regulation is less demanding than National Law.

In Portugal, national laws, partially derogated by the MDR and IVDR, are the following:

• Decree-Law n.º 145/2009, of 17^th June;
• Law n.º 21/2014, of 16^th of April;
• Decree-Law n.º 29/2024, of 5^th of April.

Submission to Competent Authority (INFARMED) and Ethics Committee (CEIC) to be performed in the following order: In parallel. Only one dossier is submitted, via RNEC or e-mail (as mentioned above), and the CA and EC coordinate with each other to review and evaluate their respective parts.

Medical Devices: https://www.rnec.pt/pt_PT

In Vitro Diagnostics Medical Device: by e-mail to clinicalstudies.devices@infarmed.pt.

On the National Ethics Committee there is a page with the requirements for submission of different types of clinical studies (https://www.ceic.pt/documentos-submissao).

MD application form: DOCUMENTAÇÃO PARA SUBMISSÃO - Investigações clínicas de dispositivos ao abrigo do Regulamento (UE) 2017/745 - NOVA

IVD application form: there isn't one yet. Submitt acording to MDCG 2022-19.

The application form requires the completion of the MDCG application forms:

MDs: https://health.ec.europa.eu/document/download/47a8a9aa-bcc5-4cf8-bed7-933ebe263711_en 

IVDs: https://health.ec.europa.eu/document/download/227ccaaf-9d3d-46ce-9f27-4d0869aaa176_en  

Included on the document of submission application for MDs: DOCUMENTAÇÃO PARA SUBMISSÃO - Investigações clínicas de dispositivos ao abrigo do Regulamento (UE) 2017/745 - NOVA. IVDs do not have this structured yet, but applicants are advised to submit it as close as possible to the MDs.

Law n.º 21/2014, of 16^th of April, if not derogated by the European Regulations on the relevant articles.

Law n.º 21/2014, of 16^th of April, if not derogated by the European Regulations on the relevant articles.

Fees for notification and authorization of
1) Clinical Investigation/Performance Study of MD or IVD without CE marking or with CE marking for other indication: 1000,00 €
2) Clinical Investigation/Performance Study of MD or IVD with CE marking for approved indication: 400,00 €
3) Substantial modification to a Clinical Investigation/Performance Study: 200,00 €
Fees are being revised to accommodate the European Regulations.

Academic Studies: No submission fees. Exemption request must be placed, either on the application submission or via e-mail beforehand.

INFARMED (CA) has a Payment Guide online. However, this document has not been revised since the entry into force of the MDR and IVDR.

Portaria nº63/2015 (Fee Ordinance) - Available only in Portuguese

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Law n.º 21/2014, of 16^th of April, if not derogated by the European Regulations on the relevant articles.

Authorization from the Administration Boards of the recruitment sites must be sought before submitting the study to the National Competent Authorities.

Submission to INFARMED (CA) and CEIC (EC) are simultaneous via RNEC (MDs) or e-mail (IVDs); only 1 dossier is needed, following the above-mentioned guidelines.

Favorable opinion from CEIC exempts the DPO of the recruitment sites of further assessment. 

For non-substantial modifications to the clinical investiagation/performance study, no form is available. However, it is recommended the use of the initial application form available on CEIC's website.

For Substancial Modifications of MDs the form on MDCG 2021-28 and for IVDs the form on MDCG 2022-20.

Applicants are advised to utilize the initial application form available on https://www.ceic.pt/documentos-submissao and submit a Dossier with the relevant documentation.

Law n.º 21/2014, of 16^th of April, if not derogated by the European Regulations on the relevant articles.

The online portal and e-mail for submission of the initial application is the same for substantial and non substantial modifications.

SAE reporting form: Appendix of MEDDEV 2.7/3.

Available on RNEC platform (https://www.rnec.pt/notificar-sae-dd).

The model of report is an Excel document from the MDCG:

• MDs: Appendix to MDCG 2020-10/1 Rev 1
• IVDs: Appendix to MDCG 2024-4

Submission process:

• MDs: RNEC portal
• IVDs: by e-mail to clinicalstudies.devices@infarmed.pt 

Law n.º 21/2014, of 16^th of April, if not derogated by the European Regulations on the relevant articles.

An Annual Safety report is mandatory both for Clinical Investigations and Performance Studies, under the Portuguese Law nº 21/2024 (Art. 22). No template is yet available for this.

PMCF/PMPF: Additionally to the reporting requirements of Clinical Investigations and Performance Studies, post-market studies must also be reported according to MEDDEV 2.12/1 rev.8 (Medical Device Vigillance System). The relevant documentation must be sent to dvps@infarmed.pt (Health Products Vigilance Unit). 

There is no template available yet. The Sponsor, or their delegate, shall submit the report, presentations and/or publication via RNEC.

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Law n.º 21/2014, of 16^th of April, if not derogated by the European Regulations on the relevant articles.

Anticipated conclusion of the trial must be notified within 15 days via RNEC.

Local ECs: There are almost 100 institutional ECs (public and private, health and academic). However, Clinical Investigations and Performance studies are of CEIC's competence.

CEIC and INFARMED coordinate internally to assess the Submission Dossier.

Guidance on documents that will be evaluated by CEIC Experts might be found at CEIC Website. Submission via RNEC.

The National Research Ethics Committee (CEIC) is responsible for assessing all MD and IVD applications, though it may delegate to a research ethics committee established by a local health institution, hospital or clinical trial site.

Regulatory and ethics bodies involved in approval process
• Competent Authority (INFARMED)
• National Ethics Committee (CEIC)
• Recruiting sites: Administration Board

Guidance, and applicable documents, may be found on CEIC's website.

Law n.º 21/2014, of 16^th of April, if not derogated by the European Regulations on the relevant articles.

MDs: National Registry of Clinical Studies: RNEC.

IVDs: by e-mail to clinicialstudies.devices@infarmed.pt. 

Application Form for MDs may be found on CEIC's website.

Application Form for IVDs not available yet.

Form only available for Clinical Investigations of MDs. Other studies are advised to follow, as closely as possible, the same structure. IVDs should use the MDCG 2022-19 as guidance.

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Law n.º 21/2014, of 16^th of April, if not derogated by the European Regulations on the relevant articles.

Law n.º 21/2014, of 16^th of April, if not derogated by the European Regulations on the relevant articles.

No fee is directly charged by CEIC. INFARMED I.P, charges sponsors the fees mentioned on the Competent Authority section, upon submission of the dossier.

Document only in portuguese and outdated: https://www.infarmed.pt/documents/15786/17838/Nova%20GP_EnsClin_Portaria63_2015%5B1%5D.pdf/b1a2d47b-eee8-46c0-a189-9f025165ca30. For more accurate information, consult the Competent Authority section.

Law n.º 21/2014, of 16^th of April, if not derogated by the European Regulations on the relevant articles.

Law n.º 21/2014, of 16^th of April, if not derogated by the European Regulations on the relevant articles.

Medical Devices: MDCG 2021-28 + the national initial submission form mentioned above.

In Vitro Diagnostics Medical Devices: MDCG 2022-20.

Applicants are advised to use the initial application form and the MDCG forms mentioned above.

Law n.º 21/2014, of 16^th of April, if not derogated by the European Regulations on the relevant articles.

All substantial notifications must be sent to both INFARMED and CEIC, in the same way as the initial submission, for both MDs and IVDs.

Portugal follows the MDCG guidelines, and as such, their templates.

Medical Devices: MDCG 2020-10/2 Rev. 1

In Vitro Diagnostics Medical Devices: MDCG 2024-4

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Law n.º 21/2014, of 16^th of April and Decree-Law nº 145/2009 of 17th of June if not derogated by the European Regulations on the relevant articles.

An Annual Safety is mandatory for all studies with MDs and IVDs and shall be submitted to the national EC and CA.

No standard form is available yet. National EC and CA accept report, publications and presentations.

Law n.º 21/2014, of 16^th of April, if not derogated by the European Regulations on the relevant articles.

The final report must be submitted to the EC and CA within 12 month after trial termination.

Sponsor - person, collective or singular, entity or institute responsible for the design, performance, management or funding of a clinical study. Law n.º 21/2014, of 16^th of April

It is mandatory to have a sponsor in all clinical studies, including MDs and IVDs.

There is no definition in the law, but, under specific circumstances, has been accepted by local ECs. No data available regarding the National Ethics Committee.

N/A.

Investigator - A person who practices a profession recognized in Portugal for carrying out research activities, due to their scientific qualifications and legal authorization to provide the required care, who is responsible for conducting the clinical study at the study center and, if applicable, for the research team that carries out the study at that center. In this case, they may be designated as the principal investigator. Law n.º 21/2014, of 16^th of April

There is no standard form. However, there are several guidance documents on the topic on CEIC's Website.

Informed Consent - The expressed decision to participate in a clinical study, freely made by a person capable of giving it, or, in the absence of such capacity, by their legal representative, after having been properly informed about the nature, scope, consequences, and risks of the study, as well as the right to withdraw from it at any time, without any consequences, in accordance with the guidelines issued by the Ethics Committee (CEC), which must include the definition of an appropriate means of providing such consent, which should be in writing, whenever applicable. Law n.º 21/2014, of 16^th of April.

Law n.º 21/2014, of 16^th of April and Decree-Law nº 145/2009 of 17th of June if not derogated by the European Regulations on the relevant articles.

Specific populations have different requirements for informed consent forms. Check European Regulations 745/2017 and 746/2017, in addition to national law.

Children from birth to 4 years-old: Both parents* Informed Consent

Children from 5 to 11: Separate form (Informed Assent) and both parents* Informed Consent

Children from 12 to 15: Separate form (Informed Assent) and both parents* Informed Consent

Children 16 to 17: Separate form (Informed Assent) and both parents* Informed Consent

In total, 4 separate models of IAF/ICF are required for minors to participate on MD and IVD studies.

*In case one of the parents has full custody or one single person detains legal representativeness, only their signature is necessary.

CEICs guidance (PT): https://www.ceic.pt/documents/20727/57550/Documento+Orientador+CEIC+sobre+Consentimento+Informado+%28CI%29+para+participa%C3%A7%C3%A3o+em+ensaios+cl%C3%ADnicos+em+pediatria/15385b28-a792-4f2b-9a57-efc184f7951c 

Law n.º 21/2014, of 16^th of April and Decree-Law nº 145/2009 of 17th of June if not derogated by the European Regulations on the relevant articles.

Incapacitated persons can only be included via Legal Representative. This person, according to Portuguese Law, IS NOT the next of kin. It must be a person with powers attributed by a court, referred to on Vital Testament or Anticipated Directive of Will. This must be verified before signing the ICF and a copy must be archived at the recruitment site.

https://www.ceic.pt/faq?p_auth=2F0GqAZq&p_p_id=faq_WAR_PortalCEICportlet&p_p_lifecycle=1&p_p_state=normal&p_p_mode=view&p_p_col_id=column-1&p_p_col_count=1&_faq_WAR_PortalCEICportlet_javax.portlet.action=navigateToPerguntas 

Clinical investigations involving subjects in emergency situations are not explicitly mentioned in Portuguese law.
As such, the provisions on European Regulations 745/2017 and 746/2017 must be respected.

It is important to adhere to recommendations of CEIC on this matter: https://www.ceic.pt/documents/20727/0/parecer+conjunto/85a27a71-19c1-4a03-9368-627358375b52 

Refer to the provisions on European Regulations 745/2017 and 746/2017 must be respected.

It is important to adhere to recommendations of CEIC on this matter: https://www.ceic.pt/documents/20727/0/parecer+conjunto/85a27a71-19c1-4a03-9368-627358375b52 

European Regulations 745/2017 and 746/2017 must be respected. CEIC's recommendations: https://www.ceic.pt/documents/20727/0/parecer+conjunto/85a27a71-19c1-4a03-9368-627358375b52 

Clinical investigations involving subjects in emergency situations are not explicitly mentioned in Portuguese law.
As such, the provisions on European Regulations 745/2017 and 746/2017 must be respected.

European Regulations 745/2017 and 746/2017.

European Regulations 745/2017 and 746/2017.

https://www.ceic.pt/ 

Still not yet for all institutions

With the new GPPR, national DP authority (CNPD) is only responsible for auditing when a complain on data breach is formalized. Additionally, DPOs from the local sites do not have to authorize clinical studies. CEIC's favorable opinion is national.

Portuguese Law nº21/2014 defines that INFARMED is the responsible party for defining timeperiods and procedures for storage of clinical study data.

According to CCMO: 10 years time retention period for MDs and IVDs and 15 for implantable MDs.

A list of applicable Portuguese legislation is available on the INFARMED website.

https://diariodarepublica.pt/dr/home 

Decree-Law nº 145/2009 of 17th of June, if not derogated by the European Regulations on the relevant articles. Decree-Law nº 29/2024 (Transposition of MDR).

Law n.º 21/2014, of 16^th of April and Law n.º 12/2005 of 17th of June, if not derogated by the European Regulations on the relevant articles.

Law nº 21/2014 of 16^th of April and Decree-Law nº 145/2009 of 17th of June, if not derogated by the European Regulations on the relevant articles. Decree-Law nº 29/2024 (Transposition of MDR).

Relevant norms and circulars on the INFARMED's website.

Law nº 21/2014 of 16^th of April and Decree-Law nº 145/2009 of 17th of June, if not derogated by the European Regulations on the relevant articles. Decree-Law nº 29/2024 (Transposition of MDR).

Relevant European Regulations directly apply to Portugal.

https://www.pgdlisboa.pt/leis/lei_mostra_articulado.php?nid=1660&tabela=leis 

Relevant European Regulations directly apply to Portugal.

Law n.º 58/2019, of 8^th of August

European General Data Protection Regulation (679/2016)

Portuguese Law nº 21/2014 of 16^th of April.

See provisions from European Regulations 745/2017 and 746/2017.

Portuguese Law nº 21/2014 of 16^th of April.

Consult relevant fees: https://www.infarmed.pt/documents/15786/17838/Nova%20GP_EnsClin_Portaria63_2015%5B1%5D.pdf/b1a2d47b-eee8-46c0-a189-9f025165ca30 

Portuguese Law nº 21/2014 of 16^th of April.

Consult relevant fees: https://www.infarmed.pt/documents/15786/17838/Nova%20GP_EnsClin_Portaria63_2015%5B1%5D.pdf/b1a2d47b-eee8-46c0-a189-9f025165ca30 

National Law derrogated by the European Regulations 745/2017 and 746/2017.

National Law derrogated by the European Regulations 745/2017 and 746/2017.

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