Overview in MDR Article 82 Context
Interventional clinical investigations of non–CE-marked MRI and MR spectroscopy devices (e.g. novel RF coils, pulse sequences) are governed by the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745). Specifically, if these trials are not undertaken to support CE-marking of the device (i.e. they are “other” clinical investigations under MDR Article 82), each EU Member State sets its own national requirements (bfarm.de). Article 82 allows Member States to define additional rules and procedures for such investigations (bfarm.de). In practice, sponsors must work with the national Competent Authority (CA) in each country and obtain a favourable ethics committee opinion before commencing any interventional use of a non-CE device in humans. All countries require compliance with MDR provisions on safety, informed consent, and ethical approval (bfarm.de). A national CA notification or authorisation is usually required (except where national law waives it for certain low-risk or academic studies). Ethics committee approval (typically from a national or accredited local ethics board) is mandatory in all cases and usually must be obtained prior to CA submission or notification (bfarm.de). Focus on MRI/MRS devices: MRI and MR spectroscopy devices are generally class IIa or IIb non-invasive devices. No Member State has device-specific extra rules solely for MRI/MRS beyond the standard medical device trial requirements; however, sponsors must ensure MRI/MRS-specific safety measures (e.g. MR safety screening, field strength considerations) are addressed as part of the general risk management and trial design (per MDR Annex I general safety and performance requirements). If the MRI study involves any ionising radiation or contrast agents, additional national regulations (e.g. radiation safety approvals or medicinal product approvals) may apply, but MRI itself (being non-ionising) does not trigger those. In summary, MRI/MRS device investigations are regulated like any other medical device clinical investigation under Article 82. Below is a country-by-country table of the national Competent Authorities and their requirements for interventional clinical investigations with non-CE-marked MRI/MRS devices not intended to obtain CE-marking (MDR Article 82). This includes the CA name and website, whether a formal authorisation or a notification is required, any specific national rules (e.g. risk-based thresholds or special procedures), the submission portal or method, and links to official guidance where available. All information is up-to-date as of 2025 and sourced from official regulations or guidance.
National Requirements for MRI/MRS Device Trials in EU Member States
Table: National Requirements for Article 82 MRI/MRS Device Trials (EU Member States)
| Country | Competent Authority (CA) (Official Name & Website) |
Submission/Notification Requirement (MDR Article 82) |
Specific Local Rules / Procedures for MRI/MRS Trials | Submission Portal / Method | Key Guidance / Links |
|---|---|---|---|---|---|
| Austria | Federal Office for Safety in Health Care (BASG) BASG – Clinical Investigations |
Authorisation or 30-day Notification – Article 82 trials must be submitted to BASG. If the investigation’s results may influence patient diagnosis/therapy, a full BASG authorisation is required (with scientific review ~45 days, per MDR Art 70(7)(b)). If the trial has no direct diagnostic/therapeutic consequences for subjects, sponsors may proceed on a notification basis (30 days prior) similar to a PMCF study (lumisinternational.com). In all cases, a positive ethics committee vote is required before submission. | No MRI-specific rules. MRI/MRS device studies are treated under the above framework based on risk to subjects. The distinction is whether the device’s use will alter patient management (triggering full CA review) or is purely observational for research (notification only) (lumisinternational.com). All general safety requirements (e.g. MR safety measures, Annex I compliance) must be met. | Electronic portal (BASG) – Applications and notifications must be submitted via BASG’s online system (electronic application form) (basg.gv.at). (The BASG PHAROS portal and application PDF/XML forms are used; paper submissions are not accepted.) | BASG Guidance: BASG follows EU MDR Art 70. Low-risk “other investigations” require only validation/notification; higher-risk require authorisation (lumisinternational.com). See BASG Guideline v11.0 on submission processes (famhp.be). |
| Belgium | Federal Agency for Medicines and Health Products (FAMHP) FAMHP – Clinical Investigations |
Authorisation Required (All Classes) – Belgium requires an official approval for all interventional device investigations. In practice, the process is risk-based per MDR: Low-risk devices (Class I or non-invasive Class IIa/IIb) can be initiated after FAMHP validates the application (no explicit wait beyond validation) (lumisinternational.com). High-risk or invasive devices (invasive Class II and Class III) undergo full scientific assessment; FAMHP issues an authorisation within ~45 days of validation (lumisinternational.com). A single combined decision with the Ethics Committee is issued (Belgium uses a coordinated review via the “College” system). | No special MRI rules. MRI coils or sequences follow the same pathway based on device class and invasiveness. Even non-invasive MRI device trials require submission to FAMHP. There are no additional local requirements specific to MRI or spectroscopy beyond standard safety considerations (e.g. ensure compliance with MR safety norms). | National portal & CESP – Sponsors submit via the Belgian CT-College portal or by secure electronic means. In practice, Belgium accepts dossiers via CESP (Common European Submission Portal) to FAMHP, which then forwards the file to the assigned Ethics Committee (fagg-afmps.be ). The application uses the EU MDR Clinical Investigation Application Form and national templates (provided on FAMHP’s site). | Belgian Guidance: Royal Decree of 18 May 2021 and FAMHP’s guidance v11.0 detail the process. Key points: ethics approval is required, FAMHP validation ~10 days, and either immediate start (for low-risk) or a 45-day review (for higher-risk studies) (lumisinternational.com). See FAMHP Guideline on Submission Processes (v11.0) and Guidance on Dossier Content (FAMHP website: famhp.be). |
| Bulgaria | Bulgarian Drug Agency (БДА / BDA) BDA – Medical Devices |
Authorisation Required – Under Bulgaria’s Medical Devices Law (aligned with MDR), sponsors must apply to the BDA for approval of any clinical investigation with a non-CE-marked device. A positive Ethics Committee opinion is required first. The BDA will review the submitted MDR Annex XV dossier and issue an authorisation before the study can start (timeline generally 45 days, extendable per MDR). No specific “notification only” route is defined – all Article 82 investigations are treated as applications. | No MRI-specific provisions. MRI/MRS device trials have no additional national conditions beyond general device trial requirements. Standard device trial safety documentation (including evidence of compliance with basic safety requirements for MR devices) must be provided. | Electronic submission – Bulgaria accepts applications using the EU MDR application form (bda.bg). Submissions are typically via email or the CESP portal (the BDA is connected to CESP). Sponsors should include all required documents (in Bulgarian or English, as applicable). The BDA’s website provides the form and instructions. | Guidance: The BDA references MDCG 2021-08 forms for applications (bda.bg). Sponsors should consult the Bulgarian Medical Devices Act (amended for MDR) and contact BDA’s Medical Devices Dept. for specifics. (No separate English guidance published; use EU forms and general MDR guidance.) |
| Croatia | Agency for Medicinal Products and Medical Devices (HALMED) HALMED – Medical Devices |
Authorisation Required – Croatia requires a formal authorisation from HALMED for interventional medical device trials under Article 82. Sponsors must submit a full application (MDR Annex XV dossier) to HALMED after obtaining Ethics Committee approval. HALMED will evaluate the safety and design of the study. There is no separate notification-only pathway; an authorisation (or tacit approval after 60 days if no objection, per MDR default) is needed before starting. | No MRI-specific requirements. MRI/MRS device investigations follow the standard process. HALMED does not impose extra rules specifically for MRI devices beyond ensuring they meet all general safety requirements (e.g. the device must comply with relevant electrical safety, EMC, and MR safety standards before use on subjects). | Email / National Portal – HALMED accepts submissions in electronic format (e.g. by email or through a national online portal if available). Sponsors typically email the application (using the EU application form) and supporting documents to HALMED’s clinical trials division. (Croatia participates in CESP, so CESP submission may also be used.) | Guidance: HALMED follows the MDR and national law updates (Croatian Medical Devices Act aligned to MDR). Key guidance is provided in Croatian on HALMED’s website. The Central Ethics Committee (CEP) in Croatia also plays a role in parallel review (halmed.hr). Sponsors should refer to HALMED’s instructions and the Ministry of Health’s guidelines for device trials. |
| Cyprus | Cyprus Medical Devices Competent Authority Ministry of Health – Medical Devices |
Authorisation Required – In Cyprus, all “other” clinical investigations must be notified to and approved by the Competent Authority (the Medical Devices section of the Ministry of Health) before commencement. The sponsor must obtain a favourable opinion from the National Bioethics Committee of Cyprus, then submit an application to the CA. The CA will issue an authorisation (or acknowledgment) typically within 60 days, as Cyprus transposed MDR Art 70 fully (no differentiation by device class is specified in available guidance). | No MRI-specific rules. Cyprus does not have special provisions for MRI/MRS device trials beyond the standard requirements. Sponsors should ensure MRI device trials comply with general subject safety and data protection rules. | Email / Postal – Sponsors usually submit via email to the Cyprus Medical Devices Competent Authority (e.g. through the email **cymda@mphs.moh.gov.cy** provided for device trials – see EU contacts list: health.ec.europa.eu). If needed, paper submission or a CD with documents may be accepted. (EUDAMED will be used once available; until then, direct email is the method.) | Guidance: The Ministry of Health has issued basic guidance via circulars. Key contacts (per EU list) are provided (health.ec.europa.eu). Sponsors should consult Cyprus’s national MDR transposition law and can contact the CA (Christiana Valianti, per EU contact list) for up-to-date procedural guidance. |
| Czech Republic | State Institute for Drug Control (SÚKL) SÚKL – Clinical Investigations |
Notification (since 2024) – The Czech Republic distinguishes Article 82 “other” investigations from CE-marking trials. As of March 2024, SÚKL requires sponsors to **notify** the authority of Article 82 investigations (rather than seek full authorisation) (sukl.gov.cz). Notifications are done via the new Information System for Medical Devices (ISZP). The sponsor must have ethics approval, then submit the notification in ISZP; SÚKL will acknowledge it (no formal decision letter needed) (sukl.gov.cz). (For CE-marking trials under Art 62 or PMCF under Art 74, a full application via the RZPRO system is required (per national law) – i.e. the standard process continues to apply for those sukl.gov.cz). | No additional MRI rules. MRI/MRS device studies fall under this notification regime if not for conformity assessment. SÚKL does not impose special conditions on MRI trials beyond standard trial safety monitoring. (If an MRI device trial introduces any invasive procedures (e.g. biopsy), those procedures may require separate approvals, but the device itself is handled under Article 82 notification.) | National Portal (ISZP) – Sponsors must use the ISZP online portal (within the Czech RZPRO system) for submitting Article 82 notifications (sukl.gov.cz). This portal requires uploading the EU application form and trial documents. (SÚKL’s system replaced email submissions; electronic submission is now mandatory.) | Official Guidance: SÚKL announced that “clinical investigations pursuant to Article 82 … shall be notified via the ISZP” (sukl.gov.cz). See SÚKL’s website for instructions and Act 375/2022 Coll. (which implemented MDR in Czech law). SÚKL’s guidance (updated Mar 2024) confirms that only a notification (not authorisation) is needed for Article 82 trials (sukl.gov.cz). |
| Denmark | Danish Medicines Agency (Lægemiddelstyrelsen) DKMA – Clinical Investigations |
No CA Authorisation – Ethics-Only Approval – Denmark has exercised MDR Article 82(2) to simplify oversight for “other investigations.” No formal application to the DKMA is required for Article 82 trials. Instead, the sponsor must obtain approval from a regional Medical Research Ethics Committee (MREC) and ensure the Article 82 conditions are met (laegemiddelstyrelsen.dk). The law in Denmark specifies that an Article 82 investigation “must be authorised under Article 82 by the Ethics Committees” (laegemiddelstyrelsen.dk), and there is no separate DKMA authorisation. (By contrast, trials for CE-marking (Art 62) still require DKMA approval (laegemiddelstyrelsen.dk), and PMCF with burden (Art 74(1)) require ethics review + a DKMA notification 30 days prior (laegemiddelstyrelsen.dk).) | No special MRI rules. Denmark treats MRI/MRS device investigations as it would any other “other clinical investigation”: only ethics approval is needed. There are no Denmark-specific technical requirements beyond the MDR for MRI devices (though if an MRI study involves additional procedures beyond scanning, those might change the regulatory frame – e.g. adding a biopsy could move it under Art 74(1) if burdensome). For a purely MRI device trial, the Article 82 pathway (ethics only) suffices. | National Ethics Portal – Sponsors must submit their protocol to the National Committee on Health Research Ethics system (Denmark has a unified online portal for ethics applications). No direct submission to the DKMA is needed for Article 82, but sponsors may notify the DKMA as a formality. The DKMA provides a common application form (used for Art 62 trials); for Art 82, submission is to ethics only (laegemiddelstyrelsen.dk). | Guidance: The Danish Medicines Agency explicitly states that Article 82 investigations require submission to the Ethics Committees, not to the DKMA (laegemiddelstyrelsen.dk). See DKMA “Notification Duty” webpage and Section 3 of the Danish Executive Order on clinical investigations. Sponsors should also follow the Danish Act on Research Ethics for trial approval. |
| Estonia | State Agency of Medicines (Ravimiamet) Estonian SAM – Medical Devices |
Authorisation Required – Estonia requires that all clinical investigations (including Article 82 trials) be authorised by the State Agency of Medicines (SAM). The sponsor must submit an application (in English or Estonian) along with a positive opinion from the Estonian Medical Research Ethics Committee. The SAM will review the dossier per MDR timelines (up to 45 days). There is no separate notification-only process in Estonia’s transposition; any use of a non-CE device on subjects needs SAM approval before starting. | No MRI-specific provisions. MRI/MRS trials are subject to the same process. Estonia does not impose extra conditions for MRI devices beyond standard safety and data protection obligations. (Any high-field MRI safety considerations are handled within the trial’s risk assessment and do not alter the regulatory submission.) | Email / CESP – The Estonian SAM accepts clinical investigation applications via email or via CESP. Typically, sponsors email the MDR application form and documents to **devices@ravimiamet.ee** or use the CESP upload. The SAM’s Medical Devices Department processes the application and coordinates issuance of the decision. | Guidance: Estonia’s requirements are outlined in the Medicinal Products Act (for drug trials) and the Medical Devices Act for device trials (updated for MDR). The official EU contact list provides a direct contact (Andis Vīlums – see health.ec.europa.eu). Sponsors should consult SAM’s website or contact the agency for any national guidance (not extensively published in English). |
| Finland | Finnish Medicines Agency (Fimea) Fimea – Investigations with Devices |
Authorisation Required – Finland treats Article 82 investigations similarly to pre-market trials. Fimea must be notified of all device investigations, and an authorisation is required for most (fimea.fi fimea.fi). Specifically, if the study is **not** to be used for conformity assessment (the Article 82 scenario), the sponsor “must apply to Fimea for an authorisation under Article 82” (fimea.fi). (Only purely observational post-market studies without additional procedures are outside this scope.) Ethics approval from the Finnish Ethics Committee (TUKIJA or regional) is needed first. Once the application is validated, Fimea has 45 days to review (with possible extension) and will issue an authorisation letter. | No MRI-specific rules. MRI/MRS device trials follow the standard Article 82 procedure. Finland’s national regulation (Act 719/2021 and Fimea’s Administrative Regulation 1/2022) does not single out imaging devices – they simply fall under Article 82. Thus, no additional approvals are needed aside from the device trial authorisation and ethics (e.g. no radiation permit is required since MRI is non-ionising). | Secure Email Submission – Prior to EUDAMED, Finland requires using a secure email system. Sponsors fill out the MDR application form (per MDCG 2021-08) and send it with all attachments via Fimea’s Secure Mail service to **kirjaamo@fimea.fi** (fimea.fi). Fimea’s secure mail allows up to 50 MB per message (fimea.fi). Alternatively, a signed paper application can be posted, but electronic submission is preferred. | Guidance: Fimea provides clear English guidance on its website. It explains the different pathways and explicitly notes that if the investigation’s results won’t be used for CE-marking, an Article 82 authorisation is required (fimea.fi). See Fimea’s “Clinical investigations of devices” page (fimea.fi) and the linked Administrative Regulation 1/2022 (in Finnish/Swedish) for detailed national requirements. |
| France | National Agency for Safety of Medicines and Health Products (ANSM) ANSM – Demande d’autorisation IC |
Authorisation Required – France requires ANSM authorisation for any Category 1 interventional research with a medical device, including Article 82 investigations. Sponsors must submit a comprehensive dossier to ANSM and to an ethics committee (CPP). ANSM conducts a scientific/technical review while the CPP gives an ethical opinion. Both approvals are required before study start. In practice, ANSM applies MDR Art 70(7): low-risk devices (e.g. Class I or IIa/IIb non-invasive) are authorised if no objection within ~30 days of validation, whereas higher-risk devices undergo a full 45-day review before approval. France’s regulations (Law n°2012-300 “Loi Jardé” as adapted to MDR) mandate ANSM approval even for “investigations non destinées au marquage CE.” | No MRI-specific exceptions. MRI/MRS device trials in France follow the standard procedure. There are no special rules solely for MRI devices. (Note: If an MRI study protocol includes ionising radiation for research purposes, the sponsor must follow separate guidance for radiation exposure (ansm.sante.fr), but MRI itself involves no ionising radiation, so that guidance (ansm.sante.fr) is not applicable to most MRI studies.) The use of 3T/7T MRI or MR spectroscopy, etc., does not alter the need for ANSM authorisation. | Email + National Portal – Until EUDAMED is functional, submissions to ANSM are done via email. ANSM instructs sponsors to email the application to **EC.DM-COS@ansm.sante.fr** (ansm.sante.fr) – using a secure Eudralink if needed. Ethics committee applications are submitted through the national RIPH2 portal (SI RIPH / CNRIPH). The ANSM and ethics reviews run in parallel, but ANSM’s authorisation is only granted after a favourable CPP opinion. | Guidance: ANSM provides detailed guidance (in French) on device trials. Key references include the “Avis aux promoteurs” (updated 14/10/2024) and Annex 1 (28/03/2025) outlining processes. France confirms all device investigations (CE-marked or not) require at least ethics approval and often ANSM authorisation (ansm.sante.fr). ANSM’s website (Chercheur section) has up-to-date instructions, and infographics are available summarising when ANSM authorisation is needed. |
| Germany | Federal Institute for Drugs and Medical Devices (BfArM) BfArM – “Other Clinical Investigations” |
Notification (with Ethics Approval) – Germany has implemented Article 82 via national law (MPDG – Medical Devices Law Implementation Act). Sponsors of Article 82 trials must **notify** BfArM (the federal authority) of the investigation (bfarm.de), rather than obtaining a traditional “authorisation.” However, a favourable Ethics Committee vote is required first, and the notification to BfArM must include the ethics approval (bfarm.de). The notification is submitted through the German Medical Devices Information and Database System (DMIDS) and must contain all Annex XV documents (bfarm.de). BfArM does not issue an approval decision for Article 82 trials but will have the trial on record; if BfArM has safety concerns, it can intervene. (Notably, Germany chose to apply the stricter path of requiring even low-risk device studies to go through this notification procedure, deviating from the MDR’s optional lighter route (bfarm.de).) | No MRI-specific rules. Germany does not single out MRI/MRS devices in its regulations – an MRI device used in a non-CE-marking study is simply an “Andere klinische Prüfung” (other clinical investigation) under §3(4) MPDG (bfarm.de). **Exception:** If an MRI device already has a CE mark and is used within its approved intended use without additional invasive procedures, a study might be exempt from the MPDG notification requirement (bfarm.de). But for a non-CE-marked MRI device, this exemption doesn’t apply – notification is mandatory. Aside from that, no special permits are needed for MRI research (no radiation license, etc.). | Online via DMIDS – Notifications must be made electronically via the DMIDS portal (bfarm.de). The sponsor uploads the application form and documents (in German; English is acceptable for technical documents) (bfarm.de). Germany enforces electronic submissions only (no paper) (bfarm.de). The DMIDS system assigns an application ID which must be referenced in correspondence. | Guidance: BfArM’s official guidance on “other clinical investigations” clarifies the process (bfarm.de). Germany’s MPDG defines “Andere klinische Prüfung” and requires ethics approval first (bfarm.de). See BfArM’s website for full details and Section 53 MPDG. BfArM also provides an English summary: essentially, notify BfArM with the ethics vote and required docs (bfarm.de). (Safety reporting for these trials still must be done to BfArM per Article 80 MDR.) |
| Netherlands | Central Committee on Research Involving Human Subjects (CCMO) CCMO – Medical Device Investigations |
Ethics-Only Approval (No CA Authorisation) – The Netherlands has a unique setup. The CCMO is designated as the Competent Authority, but for Article 82 studies, no separate CA assessment is performed – only an ethics committee review is needed. Under Dutch law (the WMO and the Medical Devices Act), “other clinical investigations” are reviewed directly by an accredited Medical Research Ethics Committee (METC); CCMO validation or Health Inspectorate (IGJ) involvement is not required (amsterdamumc.org). In practice, the sponsor submits the study via the national portal to an METC; once the METC grants a positive decision, the study can start. (The CCMO only centrally validates studies that fall under Article 62 for CE-marking; it is not involved in purely academic Article 82 trials beyond registering them.) | No MRI-specific rules. Dutch regulations do not impose additional requirements on MRI/MRS device trials. These are handled as regular WMO-governed medical research. An MRI device trial not aimed at CE-marking is simply subject to ethics approval under the WMO. There is no notification to the Health Inspectorate (IGJ) needed for Article 82 studies (ccmo.nl), meaning no special safety oversight beyond standard GCP, which the METC ensures. | National Research Portal – Sponsors must submit via the CCMO’s Research Portal (as of 2025, the new portal replacing “ToetsingOnline”) (amsterdamumc.org amsterdamumc.org). In the portal, one joint application is made which goes to an accredited METC. For Article 82, the portal categorises it accordingly and no separate CCMO review is triggered. The METC decision suffices, and the study is registered in the CCMO database automatically. | Guidance: The CCMO confirms that post-market (Art 74(1)) and other investigations (Art 82) are reviewed directly by accredited METCs with no prior CCMO validation (amsterdamumc.org). The Dutch implementation transferred CA duties to the CCMO, but effectively, Article 82 studies need only METC approval. See CCMO’s website and the Medical Research Involving Human Subjects Act (WMO) for details (english.ccmo.nl). The Dutch Central Review Decree also indicates CCMO is no longer separately authorising these; instead, METC approval = final. |
| Poland | Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) URPL – Medical Devices |
Authorisation Required – Poland requires the sponsor to obtain URPL approval for any clinical investigation of a non-CE-marked device. The process involves submitting the application (in Polish, with an accompanying summary in Polish) to URPL after securing a positive opinion from a regional ethics committee. URPL’s President will evaluate the application per MDR timelines (up to 60 days). There is no provision for mere notification – an explicit authorisation (or tacit, if no decision in time) is needed for Article 82 trials. | No MRI-specific rules. Poland has no additional requirements targeting MRI/MRS devices. Such trials must comply with general regulations and GCP. (If the MRI device trial uses any invasive procedure or contrast agent, relevant regulations apply separately – e.g. medicinal product regulations for contrast – but from a device trial perspective, URPL handles it normally.) | Electronic / Hardcopy – URPL accepts electronic submissions via CESP and also often requires a hard copy in parallel (Polish law still calls for a signed paper form in some cases). Sponsors usually send the dossier through CESP or on electronic media, followed by a confirmation letter. Communication of the decision is via official letter from URPL. | Guidance: URPL’s guidelines (Dz.U. 2022 poz. 2556) outline the procedure. The EU contact list provides URPL contacts (health.ec.europa.eu). Sponsors can refer to URPL’s website (in Polish) for application forms and checklists. Poland emphasizes that ethics approval is prerequisite and URPL will not authorise without it (journalforclinicalstudies.com). Expect the need for Polish translations of all patient-facing documents. |
| Portugal | National Authority of Medicines and Health Products (INFARMED) INFARMED – Dispositivos Médicos |
Authorisation Required – INFARMED oversees clinical investigations in Portugal. Sponsors must submit an application to INFARMED for Article 82 device trials, along with the ethics committee (CEIC) approval. INFARMED conducts a review per MDR timelines (typically ~45 days). Portugal generally requires CA authorisation for all device trials; there is no exemption for “other” investigations. (INFARMED might internally classify low-risk studies for quicker processing, but the submission and approval requirement still apply.) The trial can only commence after INFARMED’s written approval (or tacit approval if the time elapses with no decision). | No MRI-specific rules. Portugal has no special provisions for MRI/MRS device trials beyond the standard requirements. Sponsors should ensure compliance with Portuguese data protection laws and any local hospital requirements, but from INFARMED’s perspective, an MRI device trial is treated the same as any other device trial. | Online Portal (SNCS) – Portugal has an online portal for clinical trial submissions (the RNEC system for ethics review, and potentially a module for INFARMED). In practice, many sponsors submit via email or INFARMED’s online form. INFARMED often coordinates with the single national ethics committee (CEIC) via a portal. Sponsors should follow INFARMED’s latest guidance – as of now, email submission to INFARMED’s Clinical Trials Unit is common for device trials. | Guidance: INFARMED’s Guideline 01/2021 on clinical investigations (in Portuguese) details the steps. It confirms that INFARMED approval is mandatory for device investigations. The process is similar to drug trials (Portugal’s Decree-Law 145/2009 adapted for devices), but using MDR-specific forms. INFARMED’s website provides contacts for device trials and a checklist of required documents. |
| Romania | National Agency for Medicines and Medical Devices of Romania (ANMDMR) ANMDMR – Dispozitive Medicale |
Authorisation Required – Romania mandates that all medical device clinical investigations be authorised by ANMDMR. The sponsor must submit an application (in Romanian or with Romanian translations of key documents) after obtaining approval from the National Ethics Committee. ANMDMR will review the dossier and issue an authorisation decision within ~60 days. No simplified notification route exists in Romanian law – Article 82 trials are handled with full regulatory oversight, similar to pre-market trials. | No MRI-specific rules. Romania does not impose any additional requirements on MRI/MRS device trials. These studies must follow general norms (e.g. Order 1009/2016 for clinical investigations, updated for MDR). An MRI device investigation is treated as any other under MDR: the safety of subjects must be demonstrated, but no extra approvals are needed just because it’s MRI. | Email / Portal – ANMDMR accepts submissions via email and might require a physical copy in some cases. There is a national portal (RENASERT) for drug trials; for devices, currently submissions are done by email to the Devices Directorate. The application form and annexes must be provided, and ANMDMR corresponds via email for any queries and for the final decision. | Guidance: The ANMDMR website (mostly in Romanian) provides guidance and forms. Romania’s MDR transposition (Law 95/2006, updated) outlines that ANMDMR authorises device trials. Sponsors can refer to ANMDMR Order 128/2021 which details clinical investigation procedures. Particular emphasis in Romania is placed on ensuring informed consent and insurance coverage for subjects. |
| Slovakia | State Institute for Drug Control (ŠÚKL) ŠÚKL – Medical Devices |
Authorisation Required – Slovakia requires that sponsors obtain ŠÚKL’s authorisation for any interventional device study. The sponsor submits the MDR application (in Slovak, or with a Slovak summary) plus the Ethics Committee approval to ŠÚKL. The institute reviews the dossier and issues a decision within 60 days (45 days for initial review + possible 15-day extension). Slovakia did not enact a special Article 82 notification waiver, so even non-CE-marking trials need formal approval. | No MRI-specific rules. There are no additional Slovak requirements for MRI/MRS device trials. They are subject to the same review process as other device investigations. Investigators should follow standard MR safety practices, but from the regulatory point of view, nothing extra is mandated for MRI. | Online Registry (RZPRO) – Slovakia uses the Czech-developed RZPRO system for medical device registrations and likely for trial submissions (Slovakia has access to a similar registry platform). Until a dedicated portal is confirmed, sponsors typically email the application to ŠÚKL’s Devices Section (contacts: Marek Slávik / Boris Zajac – see health.ec.europa.eu). ŠÚKL may soon integrate an online submission process analogous to the Czech ISZP. | Guidance: ŠÚKL provides information in Slovak on its requirements. The EU contact info lists the responsible persons (health.ec.europa.eu). The Slovak Act on Medical Devices (No. 362/2011 Z.z., as updated) requires approval for clinical investigations. Sponsors often work with local CROs or consultants for compliance with Slovak documentation and translation needs. |
| Slovenia | Agency for Medicinal Products and Medical Devices (JAZMP) JAZMP – Medical Devices |
Authorisation Required – In Slovenia, the JAZMP must authorise all clinical investigations of medical devices that are not CE-marked or are being used outside their approved label. The sponsor submits an application to JAZMP along with a positive opinion from the National Medical Ethics Committee. JAZMP reviews the technical dossier and typically responds within ~60 days. There is no special provision for mere notification – an explicit approval (or tacit, if no response in time) is needed as per Slovenian law. | No MRI-specific rules. Slovenia does not impose extra requirements on MRI/MRS trials. An MRI device trial will be evaluated on the same criteria (safety, performance, risk mitigation) as any other device trial. No additional approvals are needed (e.g. there is no separate radiology commission since MRI is not ionising). | Email / Portal – JAZMP accepts electronic submissions (likely via email or secure file transfer). The application form (in Slovene or English) and supporting documents can be sent to JAZMP’s Clinical Trials department. Being a relatively small agency, JAZMP may also accept physical submissions, but email is commonly used. (Once EUDAMED is live, that EU portal will become the primary route.) | Guidance: JAZMP’s official publications (in Slovene) outline the process. The Medicinal Products Act in Slovenia was amended to cover device trials under the MDR. Key contact info is provided in EU lists (health.ec.europa.eu). Sponsors should ensure they follow any additional guidance from JAZMP (e.g. on the language of documents – patient materials will likely need Slovene translations). |
| Spain | Spanish Agency of Medicines and Medical Devices (AEMPS) AEMPS – Investigaciones Clínicas |
Authorisation Required – Spain requires AEMPS authorisation for all medical device clinical investigations, including non-CE-marked device studies. The sponsor must submit a request to AEMPS (in Spanish) along with a favourable opinion from a certified Ethics Committee (CEIm). AEMPS conducts a review (with input from experts if needed) and will issue an authorisation letter if the study is approved. Under Spain’s Royal Decree 1090/2015 (adapted via Royal Decree 192/2023 for devices), there is no differentiation – even “other” investigations need approval. Low-risk trials might be reviewed faster, but the requirement to obtain AEMPS sign-off remains. | No MRI-specific rules. Spain does not impose additional requirements specifically for MRI/MRS device trials. These trials are treated like any other device trial. (If the MRI device trial includes any invasive procedures beyond the imaging, those would already be covered in the ethics/AEMPS evaluation.) Standard MRI safety (e.g. screening out contraindicated implants in volunteers) is handled as part of trial risk management, not a regulatory condition. | Online Portal (ECPS) – Spain uses an electronic submission platform (ECPS, part of AEMPS) for clinical trial applications. Sponsors upload the dossier through this portal. In parallel, the study must be entered into the Spanish clinical trial registry (REec, via the RAEFAR system). Communication with AEMPS (e.g. responses to questions) is done via the platform or by email through AEMPS’s point of contact (email **psinvclinic@aemps.es** for device trials – see health.ec.europa.eu). | Guidance: AEMPS provides comprehensive guidance (in Spanish) on its website, including a guidance document for clinical investigations of devices. It emphasizes that an AEMPS authorisation is mandatory for device trials. The EU contact list gives the AEMPS contact and dedicated email for device trials (health.ec.europa.eu). Sponsors should consult AEMPS’s *Guía de investigaciones clínicas con productos sanitarios* and Royal Decree 192/2023 for details on submission content and timelines. (Spain also has a single national ethics procedure coordinated via the autonomous regions; both AEMPS approval and a favorable ethics opinion are required to start the study.) |
| Sweden | Swedish Medical Products Agency (Läkemedelsverket) MPA – Clinical Investigations |
Authorisation/Notification (Risk-Dependent) – Sweden requires that all device trials be submitted to the MPA (since July 2021) for approval or acknowledgment. In practice, the requirement is risk-based: Most studies require an MPA authorisation, but some lower-risk investigations follow a notification process. For non-CE-marked devices not aimed at CE-marking (Article 82), sponsors must **notify** the MPA and often also apply for approval. Generally, Class I or non-invasive Class IIa/IIb devices: the MPA coordinates a quick review and if everything is in order, the trial may start shortly after validation/acknowledgment (akin to MDR Art 70(7)(a) immediate start) (bsigroup.com). Higher-risk (invasive IIb/III) devices: require a full MPA authorisation within ~45 days (bsigroup.com). The MPA usually issues a combined decision together with the Ethics Review Authority’s opinion (Sweden harmonises these review processes). **Summary:** Practically, even Article 82 trials must be submitted to the MPA; the MPA will either issue an authorisation or, for very low-risk studies, simply not object (but submission is mandatory in both cases). | No MRI-specific rules. Sweden does not have additional rules for MRI/MRS device trials. The requirement that all trials go to the MPA applies equally to MRI studies. No separate permits are needed for MRI (except if the study involves, for example, ionising radiation or radiopharmaceuticals, which MRI does not). Investigators should check if a radiation protection committee approval is needed (not for MRI itself, but this may be required for certain clinical studies in Sweden – mentioned generally on kliniskastudier.se). For MRI-only studies, this is not applicable. | Online Application (via CTIS & Local Portal) – Sweden is moving toward a coordinated submission process. Until EUDAMED’s device module is active, sponsors use the Swedish national portal for clinical studies. In many cases, sponsors email the application to **registrator@lakemedelsverket.se** or use the MPA’s online form (JavaScript-enabled site). The MPA and the Ethics Authority have a coordinated process: the sponsor submits once and both bodies review it together. Sweden has effectively implemented a single application / one-decision model (similar to the EU CTR for drugs) for device trials (kliniskastudier.se). The MPA’s website provides the necessary forms and instructions. | Guidance: The Swedish MPA states “all clinical investigations in Sweden have to be submitted to the MPA… This applies also for those not for CE-marking.” Swedish guidance (in English on MPA’s site) indicates that most device studies must be either notified or approved by the MPA, and that the MPA often coordinates with the Ethics Authority (kliniskastudier.se). The national research infrastructure site (kliniskastudier.se) also confirms that MPA review is required in addition to ethical review. Sponsors should follow the MPA’s “Application and Notification” guidelines, which detail the 45-day review for high-risk studies and immediate start for low-risk categories, aligning with MDR Art 70(7)(a) and (b). |
Notes: All trials listed above require appropriate insurance coverage for participants and compliance with ISO 14155:2020 (the Good Clinical Practice standard for medical device investigations). Additionally, once EUDAMED’s clinical investigation module becomes functional (expected by 2026–2027), submissions may transition to that EU portal, but until then, national procedures as described above remain in effect (lumisinternational.com). Sponsors should always verify the latest national requirements with the Competent Authorities, as countries may update their processes or portals. Each country’s official guidance documents (where available in English) have been linked or referenced to assist with more detailed requirements.