BfArM · Europe

Germany medical device regulatory resources

Every Germany dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

5 free resources24/25 requirements coveredAug 2026 fees reviewed

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Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Germany requirements.

Medical device regulation news

Follow recent Federal Institute for Drugs and Medical Devices (BfArM) policy, guidance, safety, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary BfArM risk class with official rule references.

Government registration fees

Review current BfArM application, review, and renewal fees.

Registration timeline

Compare the statutory notified-body conformity assessment clock under Regulation (EU) 2026/977 with realistic CE marking times by device class.

Structured regulatory requirements

Explore all 47 source-linked facts →

24 of 25 research dimensions currently covered · 28 official sources · latest verification 2026-08-30

Market entry

D01

Authority & regime

Verified

Competent authority: Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte) is the competent higher federal authority (Bundesoberbehörde) for medical device…
IVD split of competence to Paul-Ehrlich-Institut: The Paul Ehrlich Institut (PEI), not BfArM, is competent for IVD tasks under the MPDG where the device falls under IVDR Annex VIII rules 1, 2 and 3(a) to (e) and (g), and for companion diag…

4 source-linked facts

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

National implementation act (MPDG): The Medizinprodukterecht Durchführungsgesetz (MPDG, official long title: Gesetz zur Durchführung unionsrechtlicher Vorschriften betreffend Medizinprodukte) is Germany's national act impleme…
National incident-reporting ordinance (MPAMIV): The Medizinprodukte Anwendermelde und Informationsverordnung (MPAMIV: Verordnung über die Meldung von mutmaßlichen schwerwiegenden Vorkommnissen bei Medizinprodukten sowie zum Informationsa…

4 source-linked facts

Checked 2026-08-25

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D03

Device definition & scope

Verified

BfArM legal-status determination: On application of a competent authority, the manufacturer, its authorised representative or its notified body, the competent federal higher authority (BfArM) determines (entscheidet) the le…

1 source-linked fact

Checked 2026-08-25

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D04

Classification rules

Verified

EU MDR classes I, Is, Im, Ir, IIa, IIb and III: Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III

1 maintained scheme · 1 related fact

Checked 2026-08-26

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D05

Registration pathways

Verified

DMIDS registration duty until 28 May 2026: Products had to be notified in the German Medical Devices Information and Database System (DMIDS) until the mandatory use of EUDAMED from 28 May 2026 (transition provisions § 96 and § 96a M…
EUDAMED registration deadline for products already on the market: From 28 May 2026 newly placed products are registered exclusively via EUDAMED, and products already on the market that continue to be placed on the market after 28 May 2026 must be register…

4 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

EU CE under MDR/IVDR — single market validity: target: geo:deu · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · loc…

1 source-linked fact

Checked 2026-08-30

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D07

Economic-operator roles

Verified

Importer/distributor national notification duties: Under § 81 MPDG, importers (implementing MDR/IVDR Art. 13(2) subpara 2 / (7) information duties) and distributors (Art. 14(2) subpara 2 and (4)) must notify: (1) assumption of a serious ris…

1 source-linked fact

Checked 2026-08-25

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D08

Establishment, import & distribution

Verified

Pre-activity notification for reprocessors (§ 4 Abs. 1 MPDG): Businesses that reprocess products intended for low germ or sterile use exclusively for others, and health institutions that reprocess single use products under MDR Art. 17(3) (or have them…
Pre-activity notification for class III implantable custom-device manufacturers: Establishments that manufacture implantable custom made devices (Sonderanfertigungen) of class III must notify the competent authority before taking up the activity, stating their address,…

2 source-linked facts

Checked 2026-08-25

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D09

Dossier requirements

Verified

Free sale certificates issued by Länder authorities: In Germany, free sale certificates (Freiverkaufszertifikate / certificates of free marketability) are issued only by the competent Landesbehörde (state authority) on application by a manufa…

1 source-linked fact

Checked 2026-08-25

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D10

Official forms & portals

Verified

DMIDS as central national portal (§ 86 MPDG): The German Medical Devices Information and Database System (DMIDS, Deutsches Medizinprodukteinformations und Datenbanksystem) provides, among other functions, a central portal for applicati…
BfArM reporting and application hub: BfArM operates an 'Anträge und Meldungen' hub with online forms for: reporting suspected serious incidents (schwerwiegende Vorkommnisse), reporting recalls/field safety corrective measures,…

3 source-linked facts

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

German-language duty for user and patient information: Products may only be supplied to users and patients in Germany if the information intended for them is made available in German; in justified cases the information may instead be in English…
Implant-card information in German: The manufacturer of an implantable product must make the information for the patient referred to in MDR Art. 18(1) (implant card and information) available in German.

3 source-linked facts

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

Manufacturer quality management system (Art. 10(9)): Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effe…

1 source-linked fact

Checked 2026-08-29

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D13

Standards, testing & ancillary approvals

Verified

MDR electrical safety in place of the Low Voltage Directive: Electrical safety
MDR electromagnetic compatibility in place of the EMC Directive: EMC
Funkanlagengesetz (RED) conformity: Wireless / radio

10 maintained overlays

Checked 2026-08-29

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D14

Fees

Verified

DiGA (digital health application) listing application: EUR 3,000–9,900
DiGA decision on a listing-related matter (preliminary approval etc.): EUR 1,500–6,600

3 maintained fee lines

Checked 2026-08-25

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D15

Review clocks

Unresolved

Class I · Self-declaration (no notified body): 0 days

1 maintained pathway · 1 related fact

Checked 2026-08-29

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D16

Approval validity & renewal

Verified

Certificate validity and renewal (Art. 56(2)): EU certificates issued by notified bodies are valid for the period they indicate, which may not exceed five years. On application by the manufacturer the validity of the certificate may be…

1 source-linked fact

Checked 2026-08-29

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Lifecycle & post-market

D17

Change control

Verified

Substantial-modification rejection clock (clinical investigations): If the federal higher authority intends to reject a substantial modification of a clinical investigation/performance study, it informs the sponsor within 37 days of receipt of the notificat…

1 source-linked fact

Checked 2026-08-25

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D18

UDI, listing & traceability

Verified

EUDAMED UDI/Devices registration mandatory from 28 May 2026: From 28 May 2026 the EUDAMED UDI/Devices module must be used for registration of newly placed products; capture of new product notifications via DMIDS was deactivated on 28 May 2026, and pr…
Official UDI or listing surface: submissionSurface: EUDAMED UDI/Devices module (mandatory for new devices from 28 May 2026; legacy devices by 28 November 2026); DMIDS was the national listing surface under § 96/96a MPDG un…

2 source-linked facts

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

Clinical investigation application to BfArM via DMIDS: The clinical investigation authorisation required under MDR Art. 62(4)(a) must be applied for by the sponsor at the competent federal higher authority, BfArM; the application is submitted b…
IVDR performance-study application via DMIDS: The authorisation for a performance study required under IVDR Art. 58(1) or (2) must be applied for by the sponsor at the competent federal higher authority; the application is submitted by…

5 source-linked facts

Checked 2026-08-25

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D20

Special access & derogation

Verified

National special authorisation (Sonderzulassung): Under the conditions of MDR Art. 59(1) / IVDR Art. 54(1), the competent federal higher authority may, on reasoned application, authorise the placing on the market or putting into service of…

1 source-linked fact

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

Post-market surveillance reporting (Arts. 83-86): Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device…

1 source-linked fact

Checked 2026-08-29

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D22

Vigilance & incident reporting

Verified

Professional operators and users must report suspected serious incidents: Anyone who professionally or commercially operates or uses medical devices must report suspected serious incidents (mutmaßliche schwerwiegende Vorkommnisse) that occur in that context immed…

1 source-linked fact

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

FSCA/recall reporting to BfArM: Manufacturers must report field safety corrective measures in relation to medical devices (e.g. recalls) to BfArM in accordance with MDR and IVDR; BfArM operates the corresponding reporting…
Field safety notice must be in German: Field safety notices sent to users under MDR Art. 89(8) / IVDR Art. 84(8) in connection with field safety corrective measures must be drafted in German.

4 source-linked facts

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

Heilmittelwerbegesetz applies to device advertising: The Heilmittelwerbegesetz (HWG, Act on advertising in the healthcare sector) applies under § 1 Abs. 1 Nr. 1a to advertising for medical devices within the meaning of MDR Art. 2(1) and for I…
Medizinprodukteberater qualification requirement: Anyone who professionally informs Fachkreise (healthcare professionals) about medical devices or instructs them in the proper handling of medical devices may exercise this activity only if…

2 source-linked facts

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

MPDG deficiency cure and clock handling: Where documents are missing without justification or the application is otherwise not in order, the competent ethics committee calls on the sponsor to cure the named defects within ten days…
Objection and action against an authority decision: A decision of BfArM or of a Land authority on a medical device is an administrative act, so before an action to set it aside its lawfulness and expediency are re examined in a preliminary p…

2 source-linked facts

Checked 2026-08-30

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Government fees

Full fee schedule (3 lines) →

BfArM registration fees in EUR · reviewed 2026-08-25

Fee line	Amount	Provenance
DiGA (digital health application) listing application	EUR 3,000–9,900	Verified
DiGA decision on a listing-related matter (preliminary approval etc.)	EUR 1,500–6,600	Verified
DiGA other decisions	EUR 1,500–4,900	Verified