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 authorityFrance
1888 Manufacturers
8235 Basic UDI-DIs
30856 Devices
Agencia Española de Medicamentos y Productos Sanitarios
Competent authoritySpain
2043 Manufacturers
8122 Basic UDI-DIs
30506 Devices
Agency for Medicinal Products and Medical Devices
Competent authorityCroatia
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 authoritySlovenia
87 Manufacturers
61 Basic UDI-DIs
4444 Devices
Austrian National Public Health Institute
Competent authorityAustria
292 Manufacturers
556 Basic UDI-DIs
2818 Devices
Bulgarian Drug Agency Department "Market Supervision and lnspections" Division "Medical Devices"
Competent authorityBulgaria
49 Manufacturers
289 Basic UDI-DIs
802 Devices
Cyprus Medical Devices Authority, Medical and Public Health Services, Ministry of Health
Competent authorityCyprus
28 Manufacturers
22 Basic UDI-DIs
50 Devices
DE/CA01 - Landesamt für soziale Dienste Schleswig-Holstein Abteilung 3 Gesundheits- und Verbraucherschutz
Competent authorityGermany
185 Manufacturers
368 Basic UDI-DIs
940 Devices
DE/CA05 - Behorde fur Justiz und Verbraucherschutz
Competent authorityGermany
778 Manufacturers
7759 Basic UDI-DIs
29389 Devices
DE/CA08 - Staatliches Gewerbeaufsichtsamt Braunschweig
Competent authorityGermany
39 Manufacturers
31 Basic UDI-DIs
131 Devices
DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
Competent authorityGermany
554 Manufacturers
16374 Basic UDI-DIs
21015 Devices
DE/CA10 - Staatliches Gewerbeaufsichtsamt Lüneburg Abteilung 3 Medizinprodukte
Competent authorityGermany
42 Manufacturers
2256 Basic UDI-DIs
2482 Devices
DE/CA100, Paul-Ehrlich-Institut, Referat S2-Pharmakovigilanz 2
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA11 - Staatliches Gewerbeaufsichtsamt Oldenburg Dezernat Gesundheitswesen, Medizinprodukte und Strahlenschutz
Competent authorityGermany
33 Manufacturers
130 Basic UDI-DIs
975 Devices
DE/CA126, Bayerisches Landesamt fur Gesundheit und Lebensmittelsicherheit AP1 - Klinischer Prufungen
Competent authorityGermany
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 authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA128, Ministerium für Umwelt und Verbraucherschutz
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA14 - Senatorin für Gesundheit, Frauen und Verbraucherschutz
Competent authorityGermany
28 Manufacturers
20 Basic UDI-DIs
25 Devices
DE/CA153, Ministerium für Soziales und Integration Baden-Württemberg; Abteilung 5 Referat 56
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA155, Ministerium für Soziales, Gesundheit, Integration und Verbraucherschutz Brandenburg - Referat 15 (active medical devices)
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA156, Hessisches Ministerium für Soziales und Integration
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA157, Niedersächsisches Ministerium fur Soziales, Gesundheit und Gleichstellung Referat 407
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA160, Ministerium für Soziales, Arbeit, Gesundheit und Demografie
Competent authorityGermany
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 authorityGermany
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 authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA164, Ministerium für Soziales, Gesundheit, Jugend, Familie und Senioren
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA165, Thüringer Ministerium für Arbeit, Soziales, Gesundheit, Frauen und Familie
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA18 - Bezirksregierung Arnsberg
Competent authorityGermany
118 Manufacturers
75 Basic UDI-DIs
278 Devices
DE/CA19 - Bezirksregierung Detmold Dezernat 24
Competent authorityGermany
86 Manufacturers
485 Basic UDI-DIs
894 Devices
DE/CA196, Bundesamt fur lnfrastruktur, Umweltschutz und Dienstleistungen der Bundeswehr GS ÖrABw
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA197, Kommando Sanitätsdienst der Bundeswehr Sachgebiet V 1.4 Arzneimittel- und Medizinproduktesicherheit
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA20, Bezirksregierung Düsseldorf Dezernat 24
Competent authorityGermany
1372 Manufacturers
6719 Basic UDI-DIs
15166 Devices
DE/CA21 - Bezirksregierung Köln Dezernat 24
Competent authorityGermany
231 Manufacturers
524 Basic UDI-DIs
2221 Devices
DE/CA22 - Bezirksregierung Münster
Competent authorityGermany
577 Manufacturers
2323 Basic UDI-DIs
5854 Devices
DE/CA23 - Regierungspräsidium Darmstadt Dezernat IV/Da 45.2
Competent authorityGermany
150 Manufacturers
497 Basic UDI-DIs
2772 Devices
DE/CA24 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
Competent authorityGermany
155 Manufacturers
869 Basic UDI-DIs
6515 Devices
DE/CA29 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
Competent authorityGermany
333 Manufacturers
3026 Basic UDI-DIs
6364 Devices
DE/CA30 - Regierungspräsidium Kassel Dezernat 55 Medizinprodukte und Produktsicherheitsrecht
Competent authorityGermany
54 Manufacturers
675 Basic UDI-DIs
1365 Devices
DE/CA302 - Regierungspräsidium Tübingen, Abteilung 11, Referat 113, Produktsicherheit Verbraucherprodukte, Medizinprodukte im Handel
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA302, Regierungspräisidium Tübingen, Abteilung 11, Referat 113, Produktsicherheit Verbraucherprodukte, Medizinprodukte im Handel
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA304 - Marktüberwachung Medizinprodukte Bayern
Competent authorityGermany
1277 Manufacturers
4159 Basic UDI-DIs
15961 Devices
DE/CA32 - Landesamt für Soziales, Jugend und Versorgung
Competent authorityGermany
140 Manufacturers
1003 Basic UDI-DIs
2532 Devices
DE/CA36 - Regierungspräsidium Gießen Abteilung II_Dezernat 25.1 - Arbeitsschutz Gießen I
Competent authorityGermany
89 Manufacturers
1995 Basic UDI-DIs
2903 Devices
DE/CA37, Regierungspräsidium Stuttgart
Competent authorityGermany
171 Manufacturers
405 Basic UDI-DIs
3590 Devices
DE/CA38 - Regierungspräsidium Karlsruhe
Competent authorityGermany
315 Manufacturers
13045 Basic UDI-DIs
15367 Devices
DE/CA39, Regierungspräsidium Freiburg Referat 25
Competent authorityGermany
415 Manufacturers
4685 Basic UDI-DIs
17087 Devices
DE/CA40 - Regierungspräsidium Tübingen Referat 25 - Sachgebiet Medizinprodukte
Competent authorityGermany
156 Manufacturers
935 Basic UDI-DIs
2093 Devices
DE/CA59, Regierung der Oberpfalz - Gewerbeaufsichtsamt - Kompetenzzentrum Marktüberwachung
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA70 - Landesamt für Umwelt- und Arbeitsschutz
Competent authorityGermany
228 Manufacturers
781 Basic UDI-DIs
9440 Devices
DE/CA71 - Struktur- und Genehmigungsdirektion Nord
Competent authorityGermany
25 Manufacturers
48 Basic UDI-DIs
131 Devices
DE/CA72 - Struktur- und Genehmigungsdirektion Süd
Competent authorityGermany
17 Manufacturers
11 Basic UDI-DIs
43 Devices
DE/CA73 - Landesamt für Gesundheit und Soziales Berlin
Competent authorityGermany
298 Manufacturers
576 Basic UDI-DIs
2345 Devices
DE/CA76 - Landesamt für Arbeitsschutz, Verbraucherschutz und Gesundheit Abt. Gesundheit - Dezernat G4
Competent authorityGermany
83 Manufacturers
1003 Basic UDI-DIs
1429 Devices
DE/CA79, Ministerium für Arbeit, Wirtschaft und Gesundheit
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA81 - Landesamt für Gesundheit und Soziales Abteilung 5 - Abteilung Arbeitsschutz[DE]
Competent authorityGermany
48 Manufacturers
76 Basic UDI-DIs
444 Devices
DE/CA82, Landesdirektion Sachsen Referat Marktüberwachung
Competent authorityGermany
145 Manufacturers
410 Basic UDI-DIs
615 Devices
DE/CA87 - Landesamt für Verbraucherschutz des Landes Sachsen-Anhalt Dezernat 51 - Zentraldezernat Arbeitsschutz
Competent authorityGermany
35 Manufacturers
127 Basic UDI-DIs
266 Devices
DE/CA90 - Thüringer Landesamt für Verbraucherschutz Dezernat 21 Technischer Verbraucherschutz, Marktüberwachung
Competent authorityGermany
77 Manufacturers
520 Basic UDI-DIs
949 Devices
DE/CA97, Federal Ministry of Defence, Forces Policy Medical 3
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA98 - Bundeswehr Commissioner for Medicinal Product Supervision
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE/CA99 - Federal Institute for Drugs and Medical Devices, Medical Devices Division
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE_CA25, Regierungspräsidium Kassel Fachzentrum für Produktsicherheit und Gefahrstoffe
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
DE_CA50, Regierungspräsidium Tübingen Abteilung 10 - Eich- und Beschusswesen
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices
Danish Medicines Agency, Pharmacovigilance & Medical Devices
Competent authorityDenmark
415 Manufacturers
1313 Basic UDI-DIs
10835 Devices
Direction générale de la concurrence, de la consommation et de la répression des fraudes
Competent authorityFrance
0 Manufacturers
0 Basic UDI-DIs
0 Devices
Federal agency for Medicines and Health Products / / Health Products Division
Competent authorityBelgium
1056 Manufacturers
17584 Basic UDI-DIs
23839 Devices
Finnish Medicines Agency, Supervision and licences, Medical Device Unit
Competent authorityFinland
347 Manufacturers
13397 Basic UDI-DIs
19035 Devices
Health Products Regulatory Authority, Medical Devices Department
Competent authorityIreland
766 Manufacturers
9110 Basic UDI-DIs
31150 Devices
Health and Youth Care Inspectorate, department of medical technology
Competent authorityNetherlands
0 Manufacturers
0 Basic UDI-DIs
0 Devices
INFARMED – National Authority of Medicines and Health Products, I.P
Competent authorityPortugal
264 Manufacturers
1891 Basic UDI-DIs
8986 Devices
Icelandic Medicines Agency
Competent authorityIceland
11 Manufacturers
16 Basic UDI-DIs
47 Devices
Malta Medicines Authority
Competent authorityMalta
488 Manufacturers
5395 Basic UDI-DIs
13678 Devices
Ministry of Health
Competent authorityCroatia
0 Manufacturers
0 Basic UDI-DIs
0 Devices
Ministry of Health, Welfare and Sports
Competent authorityNetherlands
5230 Manufacturers
47293 Basic UDI-DIs
114793 Devices
Ministry of health - Directorate General of medical devices and pharmaceutical services
Competent authorityItaly
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 authorityLuxembourg
25 Manufacturers
24 Basic UDI-DIs
139 Devices
National Agency for Medicines and Medical Devices of Romania
Competent authorityRomania
178 Manufacturers
1504 Basic UDI-DIs
2626 Devices
National Organisation for Medicines
Competent authorityGreece
100 Manufacturers
1085 Basic UDI-DIs
4349 Devices
Nemzeti Népegészségügyi és Gyógyszerészeti Központ
Competent authorityHungary
351 Manufacturers
2924 Basic UDI-DIs
6201 Devices
Office Of Public Health
Competent authorityLiechtenstein
31 Manufacturers
125 Basic UDI-DIs
4082 Devices
State Agency of Medicines Medical Devices Evaluation Department
Competent authorityLatvia
48 Manufacturers
109 Basic UDI-DIs
214 Devices
State Agency of Medicines, Department of Medical Devices
Competent authorityEstonia
55 Manufacturers
1149 Basic UDI-DIs
1224 Devices
State Health Care Accreditation Agency under the Ministry of Health of the Republic of Lithuania
Competent authorityLithuania
58 Manufacturers
153 Basic UDI-DIs
1511 Devices
State Institute for Drug Control - Medical Device Section
Competent authorityCzechia
290 Manufacturers
2698 Basic UDI-DIs
2955 Devices
Swedish Medical Products Agency
Competent authoritySweden
602 Manufacturers
1317 Basic UDI-DIs
9236 Devices
The Medicines and Healthcare Products Regulatory Agency
Competent authorityUnited Kingdom
332 Manufacturers
1219 Basic UDI-DIs
3682 Devices
The Norwegian Medical Products Agency
Competent authorityNorway
102 Manufacturers
225 Basic UDI-DIs
679 Devices
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Competent authorityPoland
663 Manufacturers
1890 Basic UDI-DIs
15652 Devices
Turkish Medicine and Medical Devices Agency
Competent authorityTürkiye
880 Manufacturers
46604 Basic UDI-DIs
125580 Devices
Štátny ústav pre kontrolu liečiv / State Institute for Drug Control ( Slovak CA)
Competent authoritySlovakia
76 Manufacturers
917 Basic UDI-DIs
1258 Devices