How to apply for a CA Approval in the EU

🇪🇺 How to apply for a Competent Agency (CA) Approval in the EU for your MR-research

When planning a magnetic resonance (MR) research study in the EU using non-CE-marked RF hardware or novel pulse sequences, you must obtain approval from the national Competent Authority (CA) in each country where the study will run. This CA approval is required in addition to a favourable ethics committee opinion. Under the EU Medical Device Regulation (MDR 2017/745), any clinical investigation of a medical device that is not CE-marked (or used outside its approved purpose) must be authorised by the Member State’s CA before starting. This means you need to apply to the relevant health authority in each country, providing a detailed application dossier.

Common Documentation Requirements

All EU countries follow the MDR’s requirements for what documents to submit in a device trial application. Typically, you will need:

  • Application form with key trial details
  • Clinical Investigation Plan (CIP) – the study protocol
  • Investigator’s Brochure (IB) with technical and safety information
  • Patient information & informed consent (in local language)
  • Device compliance statement from the manufacturer
  • Ethics approval (or to be provided once obtained)
  • Insurance certificate for trial-related injuries
  • Data protection plan under GDPR
  • Device technical documentation summary, risk analysis, test reports
  • Supporting documents such as CVs of investigators, case report forms, photos of device

Most documentation is accepted in English by the CA, while patient documents must be in the local language. Each country has its own submission system until EUDAMED is fully operational.

Competent Authorities (CAs) for Medical Device Trials in EU/EEA

The competent agencies in the EU countries are listed below. In a first step contact these agencies to find out which procedure you need to follow to enroll your medical device trial in a compliant way. This can save you a lot of frustration and time!

CA Contact Details for EU/EEA Medical Device Trials

🇪🇺 Country Competent Authority (CA) Email Phone Postal Address
Austria BASG – Federal Office for Safety in Health Care medizinprodukte@basg.gv.at
basg-eservices@basg.gv.at		 +43 50555 36409 Traisengasse 5, A‑1200 Vienna, Austria
Belgium FAMHP welcome@fagg-afmps.be
sta.meddev@fagg-afmps.be		 +32 2 528 40 00 Avenue Galilée 5/03, 1210 Brussels, Belgium
Bulgaria BDA bda@bda.bg +359 2 839 8000 8 Damyan Gruev St., 1303 Sofia, Bulgaria
Czech Republic SÚKL urgent@sukl.cz +420 272 185 794 Šrobárova 48, 100 41 Prague 10, Czech Republic
Croatia HALMED halmed@halmed.hr +385 1 4884 100 Ksaverska cesta 4, 10000 Zagreb, Croatia
Denmark DKMA med-udstyr@dkma.dk +45 44 88 95 95 Axel Heides Gade 1, 2300 Copenhagen, Denmark
Estonia Estonian Health Board MSO@ravimiamet.ee +372 639 9300 Nooruse 1, 50411 Tartu, Estonia
Finland Fimea medicaldevice@fimea.fi
registry@fimea.fi		 +358 29 522 3602 Mannerheimintie 166, P.O. Box 55, 00034 FIMEA, Finland
France ANSM medicaldevicesvigilance@ansm.sante.fr +33 1 55 87 43 07 143–147 Bd Anatole France, 93285 Saint‑Denis Cedex, France
Germany BfArM medizinprodukte@bfarm.de +49 228 207 5300 Kurt‑Georg‑Kiesinger‑Allee 3, 53175 Bonn, Germany
Greece EOF vigilancematerial@eof.gr +30 213 20 40542 284 Mesogion Ave, 15562 Holargos, Greece
Hungary OGYÉI amd.vig@ogyei.gov.hu +36 1 476 8900 Zrínyi u. 3, 1051 Budapest, Hungary
Ireland HPRA devices@hpra.ie +353 1 676 4971 Kevin O’Malley House, Earlsfort Terrace, Dublin D02 XP77, Ireland
Italy Ministry of Health – DG Medical Devices segr.dgfdm@sanita.it +39 06 5994 2055 Via Giorgio Ribotta 5, 00144 Rome, Italy
Latvia ZVA info@zva.gov.lv
dace.kikute@zva.gov.lv		 +371 67078424 15 Jersikas Street, LV‑1003 Riga, Latvia
Lithuania State Health Care Accreditation Agency vaspvt@vaspvt.gov.lt +370 5 236 3773 Jeruzales 21, 08420 Vilnius, Lithuania
Luxembourg Ministry of Health meddevices@ms.etat.lu +352 247‑84205 1 rue Charles Darwin, L‑1433 Luxembourg
Malta Medicines Authority – Medical Devices Unit devices.medicinesauthority@gov.mt +356 2348 3000 Sir Temi Żammit Buildings, San Ġwann SĠN 3000, Malta
Netherlands CCMO / IGJ devices@ccmo.nl
meldpunt@igj.nl		 +31 88 120 5000 P.O. Box 16302, 2500 BH The Hague, Netherlands
Norway NoMA MSOD@noma.no +47 22 89 77 00 P.O. Box 240 Skøyen, N‑0213 Oslo, Norway
Poland URPL incydenty@urpl.gov.pl +48 22 492 11 90 Al. Jerozolimskie 181C, 02‑222 Warsaw, Poland
Portugal INFARMED infarmed@infarmed.pt
daps@infarmed.pt		 +351 21 798 7100 Av. do Brasil 53, 1749‑004 Lisbon, Portugal
Romania ANMDMR ioana.tene@anm.ro
oana.arsenescu@anm.ro		 +40 21 317 1158 Șos. Nicolae Titulescu 58, Sector 1, 011144 Bucharest, Romania
Slovakia ŠÚKL sukl@sukl.sk
marek.slavik@sukl.sk		 +421 2 5070 1111 Kvetná 11, 825 08 Bratislava, Slovakia
Slovenia JAZMP info@jazmp.si +386 8 2000 500 Slovenčeva ulica 22, 1000 Ljubljana, Slovenia
Spain AEMPS sgps@aemps.es +34 91 822 5618 C/ Campezo 1, Edificio 8, 28022 Madrid, Spain
Sweden MPA registrator@lakemedelsverket.se +46 18 174600 Box 26, 751 03 Uppsala, Sweden
Iceland IMA ima@ima.is +354 520 2100 Vínlandsleið 14, 113 Reykjavík, Iceland
Liechtenstein Office of Public Health medical.devices@llv.li +423 236 7336 Äulestrasse 51, Postfach 684, 9490 Vaduz, Liechtenstein

Country-specific Step-by-Step Guides

🇦🇹 Austria

  1. Obtain ethics approval from a recognised committee.
  2. Prepare the MDR application and submit it via the BASG PHAROS portal.
  3. BASG validates (~10 days) and reviews (~45 days for higher-risk).
  4. Lower-risk studies may proceed after validation without full CA review.
  5. Start only after BASG confirmation/approval and ethics clearance. Report SAEs to BASG and ethics committee.

Competent Authority: BASG (Federal Office for Safety in Health Care)

🇧🇪 Belgium

  1. Prepare the dossier with protocol, IB, insurance, patient info in Dutch/French.
  2. Submit to FAMHP via CESP or email and to a local Ethics Committee.
  3. Full CA review required; expect a consolidated decision in ~45-60 days.
  4. Begin only after FAMHP (or consolidated) approval and ethics clearance. Report SAEs to both.

Competent Authority: FAMHP (Federal Agency for Medicines and Health Products)

🇧🇬 Bulgaria

  1. Get ethics approval from the Central Ethics Commission.
  2. Submit MDR dossier to BDA with Bulgarian translations for patient materials.
  3. BDA reviews within ~60 days. Trial requires explicit approval before starting.
  4. Ensure a local PI and insurance. Report SAEs and amendments to BDA.

Competent Authority: BDA (Bulgarian Drug Agency)

🇨🇿 Czech Republic

  1. Prepare MDR dossier with Czech translations as needed.
  2. Obtain ethics approval.
  3. Submit to SÚKL. Reviews typically ~45 days, up to ~60.
  4. Start only after SÚKL authorisation and ethics clearance. Notify SÚKL of completion and SAEs.

Competent Authority: SÚKL (State Institute for Drug Control)

🇩🇰 Denmark

  1. Prepare Danish application form, CIP, IB, consent in Danish, insurance, MDR docs.
  2. Submit to DKMA via Eudralink or CD-ROM, in parallel to regional Ethics Committee.
  3. DKMA validates, reviews in ~60 days (not paused by questions).
  4. Start only after DKMA and ethics approvals. Report SAEs and submit final reports.

Competent Authority: DKMA (Danish Medicines Agency)

🇫🇮 Finland

  1. Secure ethics committee opinion.
  2. Submit MDR dossier to Fimea by secure email.
  3. Fimea validates (~10 days), reviews (~45 days). PMCF studies require 30-day notification.
  4. Low-risk may start after validation if no ethics objections. High-risk wait for explicit authorisation.
  5. Report SAEs to Fimea and ethics. Submit final study reports.

Competent Authority: Fimea (Finnish Medicines Agency)

🇫🇷 France

  1. Register in SI RIPH portal to get ID RCB, assign CPP.
  2. Prepare dossier per MDR Annex XV and Loi Jardé.
  3. Submit to ANSM by email, referencing ID RCB.
  4. Submit to CPP via SI RIPH for ethics review.
  5. ANSM reviews ~45 days. Start only after ANSM and CPP approvals.
  6. Report SAEs to both bodies.

Competent Authority: ANSM (Agence Nationale de Sécurité du Médicament)

🇩🇪 Germany

  1. Submit to Ethics Committee first, get favourable opinion.
  2. Then submit to BfArM via DMIDS with ethics approval.
  3. Low-risk may proceed if no objection in 10 days. High-risk needs explicit BfArM approval (~45 days).
  4. Start only after BfArM and ethics approvals. Report SAEs.

Competent Authority: BfArM (Federal Institute for Drugs and Medical Devices)

🇬🇷 Greece

  1. Get ethics approval.
  2. Submit MDR application to EOF (via email/hard copy).
  3. EOF and ethics reviews combined, ~60 days.
  4. Start only after EOF authorisation and ethics. Report SAEs and amendments to EOF.

Competent Authority: EOF (National Organization for Medicines)

🇭🇺 Hungary

  1. Get ethics approval from ETT-KFEB.
  2. Submit to OGYÉI with Hungarian insurance and summaries.
  3. OGYÉI reviews ~45 days. Start only after OGYÉI and ethics.
  4. Ensure investigators licensed. Report SAEs and submit final results.

Competent Authority: OGYÉI (National Institute of Pharmacy and Nutrition)

🇮🇪 Ireland

  1. Get NREC-MD ethics approval.
  2. Submit to HPRA via online portal with payment proof.
  3. HPRA validates (~10–15 days), reviews (~45 days, +20 if experts).
  4. Some studies require only 30-day notification.
  5. Start only after HPRA and ethics approvals. Report SAEs.

Competent Authority: HPRA (Health Products Regulatory Authority)

🇮🇹 Italy

  1. Prepare MDR dossier with CIP, IB, patient docs in Italian, insurance, GDPR compliance.
  2. Obtain ethics approval.
  3. Submit signed application to Ministry of Health.
  4. Class III/high-risk waits ~45 days for explicit approval. Lower-risk starts 30 days after notification if no objection.
  5. Start only after Ministry confirmation and ethics. Report SAEs.

Competent Authority: Ministry of Health (Ministero della Salute)

🇳🇱 The Netherlands

  1. Submit to accredited MREC for ethics approval.
  2. Notify CCMO by registering study on portal.
  3. High-risk gets decision in ~45 days (+20 possible). Lower-risk may take up to two 56-day cycles.
  4. Start only after MREC approval and CCMO confirmation. Report SAEs.

Competent Authority: CCMO (Central Committee on Research Involving Human Subjects)

🇳🇴 Norway

  1. Determine if it’s full application (new use), notification (PMCF), or only ethics (observational).
  2. Get ethics approval from REK KULMU.
  3. Submit to NoMA. Validation in 15 days.
  4. Low-risk starts after validation/ethics. High-risk needs explicit NoMA approval (~45 days).
  5. Start only after NoMA and ethics approvals. Report SAEs.

Competent Authority: NoMA (Norwegian Medicines Agency)

🇵🇱 Poland

  1. Get ethics approval.
  2. Submit MDR dossier to URPL with Polish docs.
  3. URPL reviews ~45 days (up to ~60). Start only after approvals. Ensure insurance compliance.
  4. Report SAEs and submit amendments/completion notices.

Competent Authority: URPL (Office for Registration of Medicinal Products)

🇵🇹 Portugal

  1. Submit to INFARMED and CEIC for ethics.
  2. INFARMED reviews ~45-60 days. Start only after both approvals.
  3. Report SAEs and substantial changes.

Competent Authority: INFARMED (National Authority of Medicines)

🇸🇰 Slovakia

  1. Get ethics approval, prepare MDR docs in Slovak.
  2. Submit to ŠÚKL, reviewed ~45-60 days.
  3. Start only after ŠÚKL and ethics approvals. Report SAEs.

Competent Authority: ŠÚKL (State Institute for Drug Control)

🇸🇪 Sweden

  1. Get ethics approval from Swedish Ethical Review Authority.
  2. Submit to MPA. Lower-risk only needs notification +30 days. High-risk gets full review (~45 days).
  3. Start only after ethics and MPA clearance. Report SAEs and final reports.

Competent Authority: MPA (Medical Products Agency)

🌍 Other EU/EEA Countries

  1. Submit MDR dossier to national CA (e.g. HALMED, JAZMP, ZVA, etc.).
  2. Obtain ethics approval.
  3. Expect ~45-day CA review, ~30-day wait for notifications on low-risk. Start only after approvals.
  4. Report SAEs and submit final study reports.

Competent Authority: Each country’s agency under MDR.

Conclusion

By preparing a robust Annex XV dossier and working early with both the Competent Authority and Ethics Committees in each country, you can run your MR device study compliantly across Europe.

 

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