The German Law on the Amendment of medical device regulations comes into effect on March 21st, 2010. These regulations pertain in particular to the new obligation to obtain a permit for clinical investigations/performance evaluations of medical devices and in-vitro diagnostics. DIMDI has adjusted the Medical Devices Information System to the new statutory regulations and converted concurrently the system to the DIMDI SmartSearch menu-driven interface.
With the coming into effect of the law adopted in July of 2009, DIMDI is also implementing the new regulations in the Medical Devices Information System. At the same time, the entire information system will be converted to a new, more comfortable user interface, the DIMDI SmartSearch. This user interface design is barrier-free in compliance with the German Accessible Information Technology Ordinance (BITV).
The regulatory changes affect in particular clinical investigations/performance evaluations: Thus, the clinical investigation of a medical device in Germany may only begin once it has received consent from the responsible ethics committee and been approved by the responsible higher federal authority. The applicants may submit both the application for consent to the ethics committee and the application for approval to the higher federal authority online through the DIMDI information system. The applicants can upload the required documents in the application form. DIMDI will then forward the applications to the corresponding offices. New applicants must first request a user code and password online with DIMDI to be able to send their applications through the information system.
The menu-driven DIMDI SmartSearch
The New Medical Devices Information System consists of three areas:
* Notification of the respective address data
* Notifications of medical devices and in-vitro diagnostics
* Applications for clinical investigations/performance evaluations
Every area includes three components: "Notifications" or "Registration", "In progress" and "Database". The users can simply switch between the areas in order to process and research notifications/applications.
Easier data entry
Data is entered using a form with sections arranged like a register, where the mandatory fields are highlighted. The system verifies the plausibility of the data already as it is being entered. When data entry is interrupted, the data remains in those form sections that have been saved. The last section serves for verification: All the entered data is presented in an overview and can still be edited if necessary.
All sponsors and those subject to compulsory notification now receive a confirmation email from DIMDI when the data has been forwarded. The responsible authority or ethics committee will also be informed of new incoming notifications/applications.
Once the responsible authority has registered the incoming data, it will finally be released in the "Database" components. Here, authorized users can search for the current status of the registered address and product notifications and the authorized/concluded clinical investigations or performance evaluations.
Further Information at DIMDI:
* Medical Devices Information System: www.dimdi.de/en/mpg/ismp/index.htm
DIMDI provides high quality information for all health care areas. It develops and operates database-supported information systems for drugs and medical devices and is responsible for a programme that evaluates medical procedures and technology (Health Technology Assessment, HTA).
DIMDI is the publisher of official medical classifications such as ICD-10-GM and OPS (German procedure classification) and maintains medical terminologies, thesauri, nomenclatures and catalogues (e.g. MeSH, UMDNS, Alpha-ID, LOINC, OID) that are important for health care telematics and other applications.
DIMDI facilitates online access to its information systems and more than 60 databases covering the entire field of medicine. It also develops and maintains software applications and operates its own data processing centre.