Germany Medical Device Registration & Market Access Guide (2026): BfArM, MPDG, EUDAMED, DiGA & Requirements

Overview of Germany's Medical Device Market

Germany is the largest medical device market in Europe and the third largest globally (behind the United States and either Japan or China, depending on the source). The market is valued at approximately €35.6 billion ($39.2 billion) in 2025, projected to grow at a CAGR of 3.3% through 2029. Germany is home to over 11,000 medical technology companies employing more than 265,000 people, with a dense network of both global multinationals and specialized mid-sized manufacturers (Mittelstand).

Around 500,000 different products certified under the EU Medical Device Regulation (MDR) are available on the German market. The country's hospital infrastructure includes 1,874 hospitals (including 36 university hospitals), employing over 228,000 physicians who treated more than 17 million inpatients in 2024.

Germany is not just a market — it is the gateway to Europe. German medical technology exports were worth approximately €31.4 billion in 2023, with 38.9% going to other EU countries. Any manufacturer serious about the European market must understand Germany's specific requirements.

Key Market Data

Metric	Value
Total market size (2025)	€35.6 billion (~$39.2 billion)
Projected CAGR (2025–2029)	3.3%
Number of certified products	~500,000
Hospitals (2024)	1,874 (incl. 36 university hospitals)
MedTech employees	265,000+
Export share	~50% of production
Number of companies	11,000+

Regulatory Framework

Germany does not have a standalone national registration system for medical devices. Instead, as an EU member state, medical devices are regulated primarily under EU-wide legislation supplemented by national implementing laws.

EU-Level Legislation

Regulation	Purpose
Regulation (EU) 2017/745 (MDR)	Primary legislation for medical devices in the EU — classification, conformity assessment, CE marking, clinical evidence, post-market surveillance
Regulation (EU) 2017/746 (IVDR)	Primary legislation for in vitro diagnostic devices
Commission Implementing Decision (EU) 2025/2371	Declares EUDAMED mandatory from 28 May 2026

National Legislation

Law	Purpose
Medizinprodukterecht-Durchführungsgesetz (MPDG)	Germany's Medical Device Law Implementation Act — implements MDR/IVDR nationally, adds German-specific requirements
Medizinproduktegesetz (MPG)	Medical Devices Act — legacy provisions still in effect for certain transition issues
Medizinprodukte-EU-Anpassungsgesetz (MPEUAnpG)	Medical Devices EU Adaptation Act — includes mandatory German-language labeling requirements
Fünftes Buch Sozialgesetzbuch (SGB V)	German Social Code Book V — governs DiGA digital health applications and reimbursement
Digitale-Versorgungs-Gesetz (DVG)	Digital Healthcare Act — enables "app on prescription" (DiGA) pathway

Key Regulatory Authorities

Authority	Role
BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)	Federal Institute for Drugs and Medical Devices — primary authority for most medical devices
PEI (Paul-Ehrlich-Institut)	Federal Institute for Vaccines and Biomedicines — responsible for medical devices containing medicines, blood products, and certain IVDs
ZLG (Zentralstelle der Länder für Gesundheitsschutz)	Central Authority of the Länder for Health Protection — designates and oversees Notified Bodies in Germany
Competent Authorities of the Länder	State-level authorities — first placing of a medical device on the German market must be registered with the appropriate state authority
G-BA (Gemeinsamer Bundesausschuss)	Federal Joint Committee — decides on reimbursement and coverage decisions

CE Marking and Market Access

All medical devices placed on the German market must bear the CE mark in accordance with the EU MDR. There is no separate "German registration" — the CE marking process is EU-wide.

Steps to Market Access in Germany

Step 1: Classification (MDR Annex VIII)

• Classify your device under MDR rules (Class I, IIa, IIb, III)
• Use the classification rules based on intended purpose, duration of use, invasiveness, and active nature

Step 2: Conformity Assessment

• Class I (non-sterile, non-measuring, non-reusable surgical): Self-declaration by the manufacturer
• Class Is, Im, Ir, IIa, IIb, III: Involvement of a Notified Body is mandatory
• The Notified Body assesses your quality management system and technical documentation

Step 3: Technical Documentation

• Prepare a complete technical file in accordance with MDR Annexes II and III
• Include clinical evaluation, risk management, labeling, and IFU

Step 4: Declaration of Conformity and CE Marking

• Issue the EU Declaration of Conformity
• Affix the CE mark to the device and packaging
• Include the Notified Body number (for Class Is and above)

Step 5: Registration

• Register the device in EUDAMED (mandatory from 28 May 2026) or DMIDS (until 27 May 2026)
• Register with the competent authority of the relevant German federal state

Step 6: Appoint Authorized Representative (if non-EU)

• Manufacturers outside the EU must appoint an EU Authorized Representative based in an EU member state
• The AR must be registered in EUDAMED with a Single Registration Number (SRN)

EUDAMED and DMIDS Registration

Current State (Before 28 May 2026)

Until EUDAMED becomes mandatory, devices must be registered in Germany's DMIDS (Medical Devices Information and Database System), operated by BfArM. DMIDS serves as the national portal for notifications and applications.

From 28 May 2026: Mandatory EUDAMED

Under Commission Implementing Decision (EU) 2025/2371, the first four EUDAMED modules become mandatory on 28 May 2026:

Module	Content	Mandatory From
Actors	Registration of manufacturers, ARs, importers, sponsors	28 May 2026
UDI/Devices	Device registration with UDI data	28 May 2026
NB/Certificates	Notified Body certificate registration	28 May 2026
Market Surveillance	National authority market surveillance data	28 May 2026
Clinical Investigations	Under development	TBD
Vigilance	Under development	TBD

Key Deadlines

Deadline	Requirement
28 May 2026	All economic operators must be registered as Actors in EUDAMED. New MDR/IVDR devices must be registered in UDI/Devices before being placed on the EU market
28 November 2026	Legacy devices and devices already on the market before 28 May 2026 must be registered in EUDAMED
28 May 2027	Notified Bodies must register all MDR/IVDR certificates issued before the mandatory use date

Critical note: There is no automatic data transfer from DMIDS to EUDAMED. Manufacturers must manually enter or bulk-upload their device data into EUDAMED.

Actor Registration

All economic operators must register in the Actor module and obtain a Single Registration Number (SRN):

• Manufacturers
• Authorized Representatives
• Importers
• System and Procedure Pack Producers
• Sponsors of clinical investigations and performance studies

German-Specific Requirements

While most medical device requirements in Germany derive from the EU MDR, several national provisions add additional obligations.

1. Mandatory German-Language Labeling

Under Article 8 of the MPEUAnpG (Medical Devices EU Adaptation Act), all medical devices sold in Germany must have German-language labels and instructions for use. This applies to all devices, regardless of where they are manufactured.

Exception: For devices intended exclusively for professional use by healthcare professionals, labeling and IFU may be provided in another language — provided that safety-related information is also provided in German or in the language of the user.

This is more restrictive than the MDR baseline, which allows each member state to set its own language requirements. Germany has chosen to mandate German.

2. Clinical Investigation Requirements

Clinical investigations in Germany are governed by MDR Articles 62–82 and Sections 24–70 MPDG. Key requirements:

• BfArM is the competent authority for clinical investigations of most medical devices
• PEI handles clinical investigations for devices containing medicines or blood products
• Application procedure is sequential: ethics committee approval must be obtained before submitting to BfArM/PEI
• BfArM has shortened approval times for mononational clinical trials
• Mandatory insurance: Adequate insurance coverage for participants is required under Section 26 MPDG
• All legacy clinical investigations not considered "initiated" under Section 99(3) MPDG had to be re-applied for under MDR

3. Post-Market Surveillance and Vigilance

Those responsible for placing medical devices on the German market for the first time are obliged to report certain incidents and recalls to BfArM or PEI. The reporting requirements follow MDR Articles 87–89, supplemented by MPDG provisions.

• Serious incidents: Must be reported to BfArM/PEI within the timelines specified by MDR
• Field Safety Corrective Actions (FSCAs): Must be reported before or at the time of implementation
• Periodic Safety Update Reports (PSURs): Must be prepared and available for review
• Trend reporting: Must be reported when statistically significant increases in non-serious incidents are identified

4. Notified Bodies in Germany

German Notified Bodies are designated by BfArM and accredited by DAkkS (German Accreditation Body). ZLG publishes updates on accredited Notified Bodies. Key Notified Bodies based in Germany include TÜV SÜD, TÜV Rheinland, and DQS.

5. State-Level Registration

The first placing of a medical device on the German market must be registered with the competent authority of the respective federal state (Bundesland). This is a notification requirement, not an approval process.

DiGA: Digital Health Applications Pathway

Germany has created a unique regulatory pathway for digital health applications (DiGA — Digitale Gesundheitsanwendungen), known as the "app on prescription" model. This pathway is available only in Germany and represents a significant opportunity for digital health manufacturers.

What Is a DiGA?

A DiGA is a CE-marked medical device (typically Class I or IIa software) that has the following properties:

• Digital health application (software/app)
• CE-marked under MDR
• Demonstrates a positive healthcare effect (Positiver Versorgungseffekt)
• Listed in the DiGA directory maintained by BfArM
• Available on prescription through statutory health insurance

Legal Basis

• Section 33a SGB V — establishes the DiGA concept
• DVG (Digital Healthcare Act, 2019) — created the DiGA fast-track pathway
• DiGAV (Digital Health Applications Ordinance) — detailed requirements for DiGA

DiGA Fast-Track Process

Step 1: Obtain CE marking under MDR (prerequisite)

Step 2: Apply for inclusion in the DiGA directory via BfArM

Step 3: Provisional listing — BfArM evaluates whether the DiGA meets data security, data protection, and quality requirements. If approved, the DiGA is provisionally listed.

Step 4: Evidence generation — During the provisional listing period (typically 12 months), the manufacturer must conduct a study demonstrating positive healthcare effects.

Step 5: Final listing — If positive effects are demonstrated, BfArM grants final listing. The DiGA is then reimbursable through statutory health insurance.

DiGA Statistics (as of March 2026)

Metric	Value
Total applications received	247
Applications for provisional listing	189
Applications for final listing	58
Positive decisions	61
Negative decisions	28
Withdrawn applications	127
Currently being processed	14
Deleted from directory	17

Key 2026 DiGA Updates

The Second Ordinance Amending DiGAV (effective February 1, 2026) introduces significant changes:

1. Continuous performance measurement: Manufacturers must collect quarterly data on usage behavior, patient satisfaction, dropout rates, and health status — reported to BfArM every six months. First submission due 15 April 2027.

2. Performance-based pricing: From January 2026, at least 20% of DiGA remuneration must be linked to performance-based factors. Standing agreements without this component must be renegotiated.

3. EU AI Act compliance: DiGA manufacturers subject to the EU AI Act must declare conformity when applying for listing in the DiGA registry.

4. Simplified notification for minor changes: Minor or editorial changes can now be reported via simplified notification with a €150 processing fee.

Fees and Costs

Germany does not charge a separate "registration fee" for medical devices beyond the EU-wide conformity assessment costs. However, there are costs associated with German-specific requirements:

Item	Estimated Cost
Notified Body assessment (Class IIa–III)	€15,000–€100,000+ depending on device class and complexity
EUDAMED registration	No fee (EU system)
DMIDS registration (until May 2026)	No fee
Clinical investigation application (BfArM)	No separate fee
DiGA application (BfArM)	No separate BfArM fee, but study costs: €50,000–€300,000+
German-language translation (labeling/IFU)	€2,000–€20,000 depending on device complexity
EU Authorized Representative (for non-EU manufacturers)	€3,000–€15,000/year
State-level notification	Typically no fee
SII certification (if applicable)	Varies

Total Estimated Cost to Market in Germany (CE Marking Included)

Route	Estimated Total Cost
Class I (self-declaration)	€5,000–€15,000 (documentation, translations, AR)
Class IIa (via Notified Body)	€20,000–€60,000 (NB fees + documentation + translations + AR)
Class IIb/III (via Notified Body)	€50,000–€200,000+ (NB fees + clinical data + documentation + translations + AR)
DiGA pathway	€75,000–€400,000+ (CE marking + DiGA evidence study + listing process)

Timelines

Step	Timeline
CE marking (Class I, self-declaration)	1–3 months (documentation preparation)
CE marking (Class IIa, via NB)	6–12 months
CE marking (Class IIb/III, via NB)	12–24+ months
EUDAMED Actor registration	1–4 weeks
EUDAMED Device registration	1–4 weeks per device
State-level notification	Immediate to 2 weeks
DiGA provisional listing	3–6 months from application
DiGA final listing	12–18 months from provisional listing
Clinical investigation approval (BfArM)	45 days, extendable by 20 days (maximum 65 days from complete submission)

Note: CE marking timelines are EU-wide, not specific to Germany. Once CE marked, market access in Germany is essentially immediate.

Practical Tips

1. Prepare for EUDAMED now: The 28 May 2026 deadline is firm. Register as an Actor immediately if you have not already. There is no automatic data transfer from DMIDS — you must re-enter everything.

2. Budget for German translations: German-language labeling is mandatory. This is a non-negotiable requirement under MPEUAnpG, not a suggestion.

3. Consider DiGA early if applicable: If your product is a digital health app, the DiGA pathway provides a direct route to reimbursement through Germany's statutory health insurance system — a rare advantage not available in most other markets.

4. Choose your Notified Body carefully: Notified Body capacity is a major bottleneck under MDR. Start the NB selection process early, especially for Class IIb and III devices.

5. Understand the dual regulatory structure: BfArM handles most devices, but PEI handles devices containing medicines or blood products. Know which authority you need before you start.

6. Plan for the state-level notification: The first placing of a device on the German market requires notification to the competent authority of the relevant federal state (Bundesland). This is straightforward but must not be overlooked.

7. Leverage Germany's strategic position: Once your device is CE marked and registered, you can market it across the entire EU. Germany's large market and central location make it the natural first entry point for EU market access.

Frequently Asked Questions

Does Germany have a separate registration system for medical devices? No. Germany follows the EU MDR framework. CE marking is the primary requirement, supplemented by EUDAMED registration (mandatory from May 2026) and state-level notification.

What is DMIDS? DMIDS (Medical Devices Information and Database System) is Germany's national portal for medical device notifications, operated by BfArM. It remains mandatory until EUDAMED becomes fully mandatory on 28 May 2026.

Do labels and IFUs need to be in German? Yes. Under the MPEUAnpG, all medical devices sold in Germany must have German-language labels and instructions for use. The only exception is for devices used exclusively by healthcare professionals, where English may be acceptable if safety information is also provided in German.

What is a DiGA? DiGA (Digitale Gesundheitsanwendungen) is Germany's unique pathway for digital health applications. A DiGA is a CE-marked medical device (typically software) listed in the BfArM directory that can be prescribed by doctors and is reimbursed by statutory health insurance.

Do non-EU manufacturers need an Authorized Representative in Germany specifically? No. Under MDR, non-EU manufacturers need an EU Authorized Representative based in any EU member state — not necessarily Germany. However, the AR must be registered in EUDAMED.

What is BfArM's role vs. PEI? BfArM (Federal Institute for Drugs and Medical Devices) is the primary authority for most medical devices. PEI (Paul-Ehrlich-Institut) handles devices containing medicines, blood products, vaccines, and certain IVDs. Both are federal higher authorities.

How do I get my device reimbursed in Germany? Reimbursement pathways depend on the device type and setting. Hospital devices are reimbursed through DRG (Diagnosis Related Groups). Outpatient devices may require listing with the G-BA (Federal Joint Committee). DiGA provides a specific reimbursement pathway for digital health apps.

Related: For EU-wide MDR requirements, see our EU MDR/IVDR Complete Guide. For CE marking costs, see our CE Marking Cost Guide. For EU Authorized Representative requirements, see our EU Authorized Representative Guide. For EUDAMED registration, see our EUDAMED Registration Guide. For registration costs across all markets, see our Medical Device Registration Cost by Country Guide.