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The most important regulations
1. EU level:
Medical Device Regulation (MDR) – EU Regulation 2017/745 on medical devices
Mandatory since May 26, 2021. The MDR thus replaces Directives 93/42/EEC (MDD) and 90/385/EEC (AIMDD). Its aim is to ensure the safety, performance, and quality of medical devices throughout their entire life cycle.
In-vitro-Diagnostic Medical Device Regulation (IVDR) – EU Regulation 2017/746 on in-vitro diagnostic medical devices
Binding since May 26, 2022. It replaces Directive 98/79/EC (IVDD) and regulates, among other things, the development, conformity assessment, market surveillance and clinical performance of in vitro diagnostic medical devices.
EUDAMED – European Database for Medical Devices
A central IT system for recording and tracking medical devices and IVDs. Currently, individual modules are already usable, but mandatory use of all modules (as of 2026) has not yet been fully implemented. For this reason, national systems such as DMIDS (Germany) or MPReg (Austria) will continue to be used for certain procedures, particularly clinical trials and DMIDS (Deutschland) performance studies MPReg (Österreich) .
2. National requirements:
Germany
MPDG (Medical Devices Implementation Act)
It supplements the MDR and IVDR and replaces large parts of the former MPG. Furthermore, it regulates national requirements for clinical trials, performance studies, ethics committees, responsibilities, and market surveillance.
DMIDS (German Medical Device Information and Database System)
Digital system of the BfArM for electronic display and management Reportable transactions in the field of medical devices. This enables a structured exchange of data between those required to report, sponsors, notified bodies and authorities.
Austria
MPG (Medical Devices Act)
In Austria, the EU regulations MDR and IVDR are supplemented by national requirements regarding safety, quality, conformity assessment, and market access. These requirements are further specified by regulations such as the Medical Devices Operator Ordinance (MPBV).
MPReg (Medical Device Register)
National Register for Medical Devices and IVDs in Austria. It records, among other things, data on initial distributors as well as testing and certification bodies. Until EUDAMED is fully operational, self-registration is mandatory according to the Medical Device Notification Ordinance. The responsible authority is Gesundheit Österreich GmbH (GÖG).
Common challenges in regulatory compliance
Implementing the EU regulations MDR and IVDR, as well as the respective national requirements, is complex. Accordingly, it demands sound expertise, precise planning, and consistent monitoring. Nevertheless, many companies reach their limits in this process.
Which regulation applies to my product (MDR or IVDR)? How does the submission process work in several countries (multinational)? Which documents and evidence are required, and what needs to be reported in the respective electronic systems (e.g. DMIDS, MPReg, EUDAMED) gemeldet – and by when?
In this context, it's easy to lose track of things. This can lead to missed deadlines, unnecessarily increased costs, and delays in starting your studies.
How we can help you
As an experienced CRO, we can provide targeted support here – with comprehensive know-how and practice-oriented implementation:
- Consulting and training: We bring you and your team up to date with the latest legal requirements.
- Review of your documents: Furthermore, we check your documentation for regulatory compliance.
- Approval procedures: We coordinate national and multinational submissions for clinical trials and performance studies in accordance with MDR/IVDR.
- Electronic systems, e.g. DMIDS: Furthermore, we support you with registration, communication and reporting in all relevant databases.
- Continuous monitoring: This ensures that your clinical trial or performance study complies with regulatory requirements and relevant ISO standards at all times.
With our support, you can master regulatory challenges efficiently – for smooth processes, reliable schedules and secure approval procedures.
