FAQ Medical Devices
FAQ Medical Devices
FAQ – Regulatory Affairs for
Welcome to the FAQ section of the EKFZ Regulatory Affairs Office. Here you will find the answers to the most frequently asked questions about regulatory topics for medical devices.
The EKFZ Regulatory Affairs Office supports you and your medical device focused project regarding development process, regulatory strategy, risk classification, documentation requirements, quality management, etc.
For questions dealing with administrative, financial or public relations issues please contact email@example.com.
While research is the general earn of new insights, development deals with initial concrete application as well as implementation. Source: https://wirtschaftslexikon.gabler.de/definition/forschung-und-entwicklung-fe-36421
For example, an important milestone for transisting from research into development is the availability of a proofed technical concept and a prototype. Within research, overall feasability tests are conducted whereas concrete application tests are conducted within development phase.
If the research object can be classified as medical device it has to fulfill the regulatory requirements for medical devices no matter if it has patient contact or not.
Please use the following link to evaluate your device fulfilling the definition requirements for a medical device.
There is no general answer here. It depends on the risk classification of the device and on the status of the development and the documentation.
For detailed consulting regarding your project please contact our EKFZ Regulatory Affairs Office.
This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Source: ISO 13485:2016
The most important documents for medical device development and CE marking are following:
- Documentation regarding design and manufacturing
- Technical Documentation according regulation (EU) 2017/745 (Medical Device Regulation – MDR)
- Risk Control Measures
- Usability documentation
In order to write these documents it is recommended to run a quality management system according to EN ISO 13485. For this purpose additional documents related to the quality management system are required.
For detailed consulting regarding your project please contact our EKFZ Regulatory Affairs Office:
Best before testing is to search if there is an applicable process and/or product standard and to check the procedure, the set up as well as the acceptance criteria therein. e.g. Sterilization of medical devices – Tests of sterility EN ISO 11737-2
During testing it is necessary to document according to the standard’s requirements.
No, the requirements regarding clinical studies described in the current German Medical Device law, are not applicable for this special type of clinical study. However, it is necessary to follow the „Ärztliche Berufsordnung“.
After the application date of the Medical Device Regulation (EU) 2017/745 there will also be requirements for these research studies, detailed described in the future „Medizinprodukte-Durchführungsgesetz“.
For all questions concerning information and research in the field of intellectual property rights such as patents, trademarks and designs, the Patent Information Centre Dresden (PIZ) at TU Dresden is your competent contact partner.