MEDICAL DEVICE MARKETACCESS IN GERMANY
BEST PRACTICES, REGULATORY, AND REIMBURSEMENTUPDATE
Gabriel Flemming
Senior Manager Chemicals & Healthcare, GTAI
www.gtai.com

GTAI Healthcare Team at your Service

Dr. Marcus Schmidt
Director Chemicals & Healthcare

Julia Albrecht
Medical Aids

Gabriel Flemming
Medical Devices

Gregor Kemper
Biotechnology & Pharmaceuticals

Julia Pietsch
Digital Health© GTAI 2

Investor Consulting• Information about keyindustries• Legal information• Tax information• Incentives and financinginformation• Introduction to local partners• Site selection support© GTAI 3

German Healthcare is Financed by Multiple
Sources
Employers
4%
Public budgets
4%
Private healthinsurance
8%

Statutory accident insurance
Statutory pension insurance
2%
1%

Social longterm careinsurance…

Statutoryhealthinsurance
57%

With a share of 57%,
statutory health ismost significant
payer

Privatehouseholds
13%
Note: The item private households includes non-profit institutions serving households.
Source: German Federal Statistical Office 2021

© GTAI 4

German Hospital Spending is Increasing
Total spending of German hospitals 2016 – 2020 (in EUR bn)
114,2

87,8

91,393,598,8• 1900+ hospitals• EUR 5.088 percase (+5.5%)

2016
Source: Statista 2022

20172018

20192020© GTAI 5

Market Access for InnovativeDevices
CE certification: MDR to replace MDD• Latest expiry of CE marks via MDD in 2025
• Classification rules: Annex VIII of (EU) 2017/745 MDR• EUDAMED is postponed• German implementation “MPDG”•

medical devices operators ordinance (MPBetreibVg)•

medical product advisor (Medizinproduktberater §83)
© GTAI 6

Market Access for Innovative Devices
Clinical trials for CE (MDR) validation: Cash grants available•

For innovative class II/III•

Grant for training phase•

Grant for innovation phase•Max. 70% of costs applicable

Source: VDI Technologiezentrum© GTAI 7

Reimbursement Pathways in Germany

Ambulatory sector (out-patient)

Hospital sector (in-patient)• Doctor practices: reimbursed if listed
in uniform evaluation standard (EBM)• G-DRG system:
reimbursed unless barred• Medical supply stores: reimbursed iflisted in medical aids register (HMV:GKV Spitzenverband)• Joint Federal Committee (G-BA)© GTAI 8

Out-patient and in-patient reimbursement
Options for manufacturers(In-patient sector)(Out-patient sector)
Reimbursement via
EXISTING
EBM code„Yes“

Reimbursement via
EXISTING
EBM code

Health Technology
Assessment initiatedby Joint Federal
Committee (G-BA)?
„Potential“„No“

Pathway§135e
successful?

Manufacturer initiates
benefit assessment inambulatory trial use?

„Yes“

„No“

Manufacturer
initiates benefit
assessment in inpatient trial use?

„Yes“

Requirements for§137h met?
„Yes“

Manufacturer action
Pathway to reimbursement

Endpoint with reimbursement
Endpoint without reimbursement
Source: BVMed/Spectaris/VDGH/ZVEI

Pathway§137h
successful?

Pathway§135e
successful?

„Yes“

„Yes“

„Ineffective“„Benefit proven“

Reimbursed via
NEW EBMcode

Reimbursed via
NEW DRG
code

No
reimburse-ment

Reimbursed via
NEW DRG

Reimbursement via
NEW DRG„Not ineffective andNUB application
by hospital„Yes“successful?

„Yes“

Reimbursement via
EXISTING
DRG„Potential“No
reimburse-ment „No“

„No“

„Yes“

no benefit proven“

Pathway§135e
section 7successful?

Joint Federal Committee action

Pathway §137c
successful?
„No“„No“Noreimburse-mentNoreimburse-ment

NUB application
by hospital?

„No“

No NUBStatus

Reimbursement withNUB-Status„Optional“
Reimbursed via
EXISTING
DRG © GTAI 9

Hospital Reimbursement Requires Strategy
Option 1: use existing DRGs+OPS

Quick access to the market (§137 c, SGB V)

Option 2: NUB track

Register your individual OPS and DRG in caseof new methods (§137 h, SGB V)

Option 3: coverage by evidence

Receive reimbursement during clinical trial(§137 e, SGB V)© GTAI 10

Clinical Trials can be Necessary
MDR: Class IIb+III

New CE requires more individual clinicaldata. Equivalence via literature is limited

G-BA: potential to be proven

Need to run clinical trials, will be reimbursed

New class III methods require RCT

Only reimbursed when „HTA“ dossier
provided by hospital and manufacturer,
benefit assessment by IQWIG© GTAI 11

Contact Us
Germany Trade & Invest is the economic development agency of the Federal Republic of Germany. The company helps create and secure
extra employment opportunities, strengthening Germany as a business location. With more than 50 offices in Germany and abroad and its
network of partners throughout the world, Germany Trade & Invest supports German companies setting up in foreign markets, promotes
Germany as a business location and assists foreign companies setting up in Germany.

ContactGTAI
Gabriel FlemmingFriedrichstraße 60
T +49 (0)30 200 099-307 10117 Berlin
Gabriel.flemming@gtai.com
www.gtai.com
Supported by the Federal Ministry for Economic Affairs and Energy
on the basis of a decision by the German Bundestag.
© Germany Trade & Invest
All market data provided is based on the most current market information available at the time of publication.
Germany Trade & Invest accepts no liability for the actuality, accuracy, or completeness of the information provided.

© GTAI 12

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www.gtai.com© GTAI 13