National requirements for the approval of medical devices in Germany
Germany is one of the largest medical technology markets in the world and, as an EU member state, is subject to the requirements of the Medical Device Regulation (MDR 2017/745) as well as supplementary national regulations. In addition to CE marking, there are specific requirements for the registration, market surveillance and reimbursement of medical devices in Germany.
This article provides an overview of the national requirements in Germany that go beyond the general EU requirements.
Competent authorities for medical devices in Germany
Medical devices are monitored by various national authorities that focus on different regulatory areas.
Federal Institute for Drugs and Medical Devices (BfArM)
The BfArM is responsible for market surveillance, risk assessment and clinical trials of medical devices.
Tasks:
- Reporting and assessment of serious incidents
- Testing of clinical studies with medical devices
- Monitoring of Post-Market Surveillance (PMS) and vigilance reports
Official website: www.bfarm.de
Paul Ehrlich Institute (PEI)
The PEI is responsible for in-vitro diagnostics (IVD) of particular importance to public health, especially blood products, vaccines and biological medical devices.
Tasks:
- Evaluation and approval of certain IVD products
- Safety monitoring of biomedical products
Official website: www.pei.de
State authorities
The Medical Devices Act (MPG) and the MDR are monitored at state level by the responsible trade supervisory offices and health authorities.
Mandatory registration for manufacturers and products in Germany
German Medical Device Information and Database (DMIDS)
In addition to EU-wide registration in EUDAMED, manufacturers and authorized representatives in Germany must register their medical devices with the German Institute of Medical Documentation and Information (DIMDI).
Obligations for manufacturers:
- Notification of the company and products in DMIDS
- Registration of authorized representatives for non-EU manufacturers
- Updating data in the event of product changes or new certifications
The BfArM provides more information on DMIDS registration.
Need for a local representative in Germany
For non-EU manufacturers, it is mandatory to appoint an authorized representative (European Authorized Representative, EU-AR) based in the EU.
Tasks of the authorized representative:
- Communication with German authorities
- Registration in national databases (DMIDS, EUDAMED)
- Checking the technical documentation
Manufacturers based in Germany do not need an additional authorized representative, but must meet all regulatory requirements.
Classification of medical devices in Germany
Medical devices are classified in accordance with MDR 2017/745 and do not differ from other EU Member States.
Classification according to MDR
- Class I - Low risk (e.g. dressings, surgical instruments)
- Class IIa - Medium risk (e.g. infusion pumps, ultrasound devices)
- Class IIb - Higher risk (e.g. anesthesia machines, defibrillators)
- Class III - High risk (e.g. heart valves, artificial joints)
Special classifications in Germany
Some product groups are subject to additional national requirements, in particular:
- In vitro diagnostic medical devices for infectious diseases - special test by the PEI
- Products with human tissue - approval by the BfArM required
Approval procedure for medical devices in Germany
A medical device is approved throughout the EU via the CE marking. However, there are additional requirements in Germany, particularly for reimbursement by health insurance companies and market access via hospitals.
What approval procedures are there?
- CE marking according to MDR - mandatory for market entry
- Registration in the DMIDS database - mandatory for Germany
- Additional requirements for high-risk products - approval by BfArM or PEI
Reimbursement procedures for medical devices in Germany
In addition to regulatory approval, reimbursement by health insurance companies is a key factor for market success.
Important reimbursement procedures:
- GKV reimbursement: Inclusion in the list of medical aids of the statutory health insurance funds
- DRG system for hospital products: Evaluation by the Institute for the Hospital Remuneration System (InEK)
- Individual cost coverage by health insurance companies for innovative products
Average duration of approval procedures
- CE marking: 3 to 24 months depending on product class
- DMIDS registration: a few weeks to a few months
- Reimbursement by health insurance companies: 6 to 24 months, depending on the procedure
Costs incurred
- DMIDS registration: No direct fees
- Notified body for CE certification: Depending on product class (10,000 - 100,000 euros)
- Reimbursement procedure: Costs for studies and applications can be high
Validity of registration and approval
- CE marking is generally valid for 5 years
- DMIDS registration remains valid as long as the product is actively marketed
Language requirements
- Technical documentation can be submitted in English
- Instructions for use, labels and packaging must be available in German
Conclusion
Germany offers a large and attractive market for medical devices, but has some national peculiarities that manufacturers must take into account.
Important points summarized:
- DMIDS registration is mandatory for all medical devices
- Non-EU manufacturers require an authorized representative (EU-AR)
- Special requirements for in-vitro diagnostics and high-risk products
- Reimbursement processes are crucial for market success
- Technical documentation can be submitted in English, labels and instructions for use must be in German
Support from MEDAGENT
MEDAGENT offers comprehensive services for the German market:
- Registration in the DMIDS database
- Advice on CE marking and technical documentation
- Support for post-market surveillance and vigilance
- Guidance through the reimbursement process with health insurance companies
For further information or assistance with the approval of medical devices in Germany, please contact us directly.
