EU MDR

Competent Authorities

A list of all MDR competent authorities in the EU.

You can see how many manufacturers and devices each one oversees. Click on one to see detailed statistics regarding its numbers on MDR class I software, which, from experience, is handled quite subjectively between different competent authorities.

Each EU country has one competent authority — except Germany, which has 32 (!), some of which oversee as little as 5 manufacturers and 12 devices. If you get confused by all the different names of German competent authorities, you can look up the region they're responsible for on the BfArM website.

Agence Nationale de Sécurité du Médicament et des Produits de Santé

Competent authority
France
1888 Manufacturers
8235 Basic UDI-DIs
30856 Devices

Agencia Española de Medicamentos y Productos Sanitarios

Competent authority
Spain
2043 Manufacturers
8122 Basic UDI-DIs
30506 Devices

Agency for Medicinal Products and Medical Devices

Competent authority
Croatia
51 Manufacturers
395 Basic UDI-DIs
2071 Devices

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia: Medical Devices Division / Pharmaceutical Inspection Division – Medical Devices Unit

Competent authority
Slovenia
87 Manufacturers
61 Basic UDI-DIs
4444 Devices

Austrian National Public Health Institute

Competent authority
Austria
292 Manufacturers
556 Basic UDI-DIs
2818 Devices

Bulgarian Drug Agency Department "Market Supervision and lnspections" Division "Medical Devices"

Competent authority
Bulgaria
49 Manufacturers
289 Basic UDI-DIs
802 Devices

Cyprus Medical Devices Authority, Medical and Public Health Services, Ministry of Health

Competent authority
Cyprus
28 Manufacturers
22 Basic UDI-DIs
50 Devices

DE/CA01 - Landesamt für soziale Dienste Schleswig-Holstein Abteilung 3 Gesundheits- und Verbraucherschutz

Competent authority
Germany
185 Manufacturers
368 Basic UDI-DIs
940 Devices

DE/CA05 - Behorde fur Justiz und Verbraucherschutz

Competent authority
Germany
778 Manufacturers
7759 Basic UDI-DIs
29389 Devices

DE/CA08 - Staatliches Gewerbeaufsichtsamt Braunschweig

Competent authority
Germany
39 Manufacturers
31 Basic UDI-DIs
131 Devices

DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover

Competent authority
Germany
554 Manufacturers
16374 Basic UDI-DIs
21015 Devices

DE/CA10 - Staatliches Gewerbeaufsichtsamt Lüneburg Abteilung 3 Medizinprodukte

Competent authority
Germany
42 Manufacturers
2256 Basic UDI-DIs
2482 Devices

DE/CA100, Paul-Ehrlich-Institut, Referat S2-Pharmakovigilanz 2

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE/CA11 - Staatliches Gewerbeaufsichtsamt Oldenburg Dezernat Gesundheitswesen, Medizinprodukte und Strahlenschutz

Competent authority
Germany
33 Manufacturers
130 Basic UDI-DIs
975 Devices

DE/CA126, Bayerisches Landesamt fur Gesundheit und Lebensmittelsicherheit AP1 - Klinischer Prufungen

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE/CA127, Ministerium für Soziales, Gesundheit, Integration und Verbraucherschutz des Landes Brandenburg Abt. 1 - Referat 17

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE/CA128, Ministerium für Umwelt und Verbraucherschutz

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE/CA14 - Senatorin für Gesundheit, Frauen und Verbraucherschutz

Competent authority
Germany
28 Manufacturers
20 Basic UDI-DIs
25 Devices

DE/CA153, Ministerium für Soziales und Integration Baden-Württemberg; Abteilung 5 Referat 56

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE/CA155, Ministerium für Soziales, Gesundheit, Integration und Verbraucherschutz Brandenburg - Referat 15 (active medical devices)

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE/CA156, Hessisches Ministerium für Soziales und Integration

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE/CA157, Niedersächsisches Ministerium fur Soziales, Gesundheit und Gleichstellung Referat 407

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE/CA160, Ministerium für Soziales, Arbeit, Gesundheit und Demografie

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE/CA162, Sächsisches Staatsministerium fur Soziales und Gesellschaftlichen Zusammenhalt Saxon State Ministry For Social Affairs and Cohesion

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE/CA163, Ministerium für Arbeit, Soziales und Integration des Landes Sachsen-Anhalt Referat 32 - Techn. und Stoffbez. Arbeitsschutz

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE/CA164, Ministerium für Soziales, Gesundheit, Jugend, Familie und Senioren

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE/CA165, Thüringer Ministerium für Arbeit, Soziales, Gesundheit, Frauen und Familie

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE/CA18 - Bezirksregierung Arnsberg

Competent authority
Germany
118 Manufacturers
75 Basic UDI-DIs
278 Devices

DE/CA19 - Bezirksregierung Detmold Dezernat 24

Competent authority
Germany
86 Manufacturers
485 Basic UDI-DIs
894 Devices

DE/CA196, Bundesamt fur lnfrastruktur, Umweltschutz und Dienstleistungen der Bundeswehr GS ÖrABw

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE/CA197, Kommando Sanitätsdienst der Bundeswehr Sachgebiet V 1.4 Arzneimittel- und Medizinproduktesicherheit

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE/CA20, Bezirksregierung Düsseldorf Dezernat 24

Competent authority
Germany
1372 Manufacturers
6719 Basic UDI-DIs
15166 Devices

DE/CA21 - Bezirksregierung Köln Dezernat 24

Competent authority
Germany
231 Manufacturers
524 Basic UDI-DIs
2221 Devices

DE/CA22 - Bezirksregierung Münster

Competent authority
Germany
577 Manufacturers
2323 Basic UDI-DIs
5854 Devices

DE/CA23 - Regierungspräsidium Darmstadt Dezernat IV/Da 45.2

Competent authority
Germany
150 Manufacturers
497 Basic UDI-DIs
2772 Devices

DE/CA24 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt

Competent authority
Germany
155 Manufacturers
869 Basic UDI-DIs
6515 Devices

DE/CA29 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt

Competent authority
Germany
333 Manufacturers
3026 Basic UDI-DIs
6364 Devices

DE/CA30 - Regierungspräsidium Kassel Dezernat 55 Medizinprodukte und Produktsicherheitsrecht

Competent authority
Germany
54 Manufacturers
675 Basic UDI-DIs
1365 Devices

DE/CA302 - Regierungspräsidium Tübingen, Abteilung 11, Referat 113, Produktsicherheit Verbraucherprodukte, Medizinprodukte im Handel

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE/CA302, Regierungspräisidium Tübingen, Abteilung 11, Referat 113, Produktsicherheit Verbraucherprodukte, Medizinprodukte im Handel

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE/CA304 - Marktüberwachung Medizinprodukte Bayern

Competent authority
Germany
1277 Manufacturers
4159 Basic UDI-DIs
15961 Devices

DE/CA32 - Landesamt für Soziales, Jugend und Versorgung

Competent authority
Germany
140 Manufacturers
1003 Basic UDI-DIs
2532 Devices

DE/CA36 - Regierungspräsidium Gießen Abteilung II_Dezernat 25.1 - Arbeitsschutz Gießen I

Competent authority
Germany
89 Manufacturers
1995 Basic UDI-DIs
2903 Devices

DE/CA37, Regierungspräsidium Stuttgart

Competent authority
Germany
171 Manufacturers
405 Basic UDI-DIs
3590 Devices

DE/CA38 - Regierungspräsidium Karlsruhe

Competent authority
Germany
315 Manufacturers
13045 Basic UDI-DIs
15367 Devices

DE/CA39, Regierungspräsidium Freiburg Referat 25

Competent authority
Germany
415 Manufacturers
4685 Basic UDI-DIs
17087 Devices

DE/CA40 - Regierungspräsidium Tübingen Referat 25 - Sachgebiet Medizinprodukte

Competent authority
Germany
156 Manufacturers
935 Basic UDI-DIs
2093 Devices

DE/CA59, Regierung der Oberpfalz - Gewerbeaufsichtsamt - Kompetenzzentrum Marktüberwachung

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE/CA70 - Landesamt für Umwelt- und Arbeitsschutz

Competent authority
Germany
228 Manufacturers
781 Basic UDI-DIs
9440 Devices

DE/CA71 - Struktur- und Genehmigungsdirektion Nord

Competent authority
Germany
25 Manufacturers
48 Basic UDI-DIs
131 Devices

DE/CA72 - Struktur- und Genehmigungsdirektion Süd

Competent authority
Germany
17 Manufacturers
11 Basic UDI-DIs
43 Devices

DE/CA73 - Landesamt für Gesundheit und Soziales Berlin

Competent authority
Germany
298 Manufacturers
576 Basic UDI-DIs
2345 Devices

DE/CA76 - Landesamt für Arbeitsschutz, Verbraucherschutz und Gesundheit Abt. Gesundheit - Dezernat G4

Competent authority
Germany
83 Manufacturers
1003 Basic UDI-DIs
1429 Devices

DE/CA79, Ministerium für Arbeit, Wirtschaft und Gesundheit

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE/CA81 - Landesamt für Gesundheit und Soziales Abteilung 5 - Abteilung Arbeitsschutz[DE]

Competent authority
Germany
48 Manufacturers
76 Basic UDI-DIs
444 Devices

DE/CA82, Landesdirektion Sachsen Referat Marktüberwachung

Competent authority
Germany
145 Manufacturers
410 Basic UDI-DIs
615 Devices

DE/CA87 - Landesamt für Verbraucherschutz des Landes Sachsen-Anhalt Dezernat 51 - Zentraldezernat Arbeitsschutz

Competent authority
Germany
35 Manufacturers
127 Basic UDI-DIs
266 Devices

DE/CA90 - Thüringer Landesamt für Verbraucherschutz Dezernat 21 Technischer Verbraucherschutz, Marktüberwachung

Competent authority
Germany
77 Manufacturers
520 Basic UDI-DIs
949 Devices

DE/CA97, Federal Ministry of Defence, Forces Policy Medical 3

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE/CA98 - Bundeswehr Commissioner for Medicinal Product Supervision

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE/CA99 - Federal Institute for Drugs and Medical Devices, Medical Devices Division

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE_CA25, Regierungspräsidium Kassel Fachzentrum für Produktsicherheit und Gefahrstoffe

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

DE_CA50, Regierungspräsidium Tübingen Abteilung 10 - Eich- und Beschusswesen

Competent authority
Germany
0 Manufacturers
0 Basic UDI-DIs
0 Devices

Danish Medicines Agency, Pharmacovigilance & Medical Devices

Competent authority
Denmark
415 Manufacturers
1313 Basic UDI-DIs
10835 Devices

Direction générale de la concurrence, de la consommation et de la répression des fraudes

Competent authority
France
0 Manufacturers
0 Basic UDI-DIs
0 Devices

Federal agency for Medicines and Health Products / / Health Products Division

Competent authority
Belgium
1056 Manufacturers
17584 Basic UDI-DIs
23839 Devices

Finnish Medicines Agency, Supervision and licences, Medical Device Unit

Competent authority
Finland
347 Manufacturers
13397 Basic UDI-DIs
19035 Devices

Health Products Regulatory Authority, Medical Devices Department

Competent authority
Ireland
766 Manufacturers
9110 Basic UDI-DIs
31150 Devices

Health and Youth Care Inspectorate, department of medical technology

Competent authority
Netherlands
0 Manufacturers
0 Basic UDI-DIs
0 Devices

INFARMED – National Authority of Medicines and Health Products, I.P

Competent authority
Portugal
264 Manufacturers
1891 Basic UDI-DIs
8986 Devices

Icelandic Medicines Agency

Competent authority
Iceland
11 Manufacturers
16 Basic UDI-DIs
47 Devices

Malta Medicines Authority

Competent authority
Malta
488 Manufacturers
5395 Basic UDI-DIs
13678 Devices

Ministry of Health

Competent authority
Croatia
0 Manufacturers
0 Basic UDI-DIs
0 Devices

Ministry of Health, Welfare and Sports

Competent authority
Netherlands
5230 Manufacturers
47293 Basic UDI-DIs
114793 Devices

Ministry of health - Directorate General of medical devices and pharmaceutical services

Competent authority
Italy
2387 Manufacturers
11024 Basic UDI-DIs
25551 Devices

Ministère de la Santé Direction de la santé Division de la Pharmacie et des Médicament Médical Devices Unit

Competent authority
Luxembourg
25 Manufacturers
24 Basic UDI-DIs
139 Devices

National Agency for Medicines and Medical Devices of Romania

Competent authority
Romania
178 Manufacturers
1504 Basic UDI-DIs
2626 Devices

National Organisation for Medicines

Competent authority
Greece
100 Manufacturers
1085 Basic UDI-DIs
4349 Devices

Nemzeti Népegészségügyi és Gyógyszerészeti Központ

Competent authority
Hungary
351 Manufacturers
2924 Basic UDI-DIs
6201 Devices

Office Of Public Health

Competent authority
Liechtenstein
31 Manufacturers
125 Basic UDI-DIs
4082 Devices

State Agency of Medicines Medical Devices Evaluation Department

Competent authority
Latvia
48 Manufacturers
109 Basic UDI-DIs
214 Devices

State Agency of Medicines, Department of Medical Devices

Competent authority
Estonia
55 Manufacturers
1149 Basic UDI-DIs
1224 Devices

State Health Care Accreditation Agency under the Ministry of Health of the Republic of Lithuania

Competent authority
Lithuania
58 Manufacturers
153 Basic UDI-DIs
1511 Devices

State Institute for Drug Control - Medical Device Section

Competent authority
Czechia
290 Manufacturers
2698 Basic UDI-DIs
2955 Devices

Swedish Medical Products Agency

Competent authority
Sweden
602 Manufacturers
1317 Basic UDI-DIs
9236 Devices

The Medicines and Healthcare Products Regulatory Agency

Competent authority
United Kingdom
332 Manufacturers
1219 Basic UDI-DIs
3682 Devices

The Norwegian Medical Products Agency

Competent authority
Norway
102 Manufacturers
225 Basic UDI-DIs
679 Devices

The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Competent authority
Poland
663 Manufacturers
1890 Basic UDI-DIs
15652 Devices

Turkish Medicine and Medical Devices Agency

Competent authority
Türkiye
880 Manufacturers
46604 Basic UDI-DIs
125580 Devices

Štátny ústav pre kontrolu liečiv / State Institute for Drug Control ( Slovak CA)

Competent authority
Slovakia
76 Manufacturers
917 Basic UDI-DIs
1258 Devices