Technical Documentation
Technical Documentation
The term technical documentation (or technical file) refers to all the documents that a medical device manufacturer has to submit. The technical file is a requirement for the conformity assessment and, therefore, for the approval of medical devices.
Medical Device Regulation (MDR)
Medical Device Regulation (MDR)
The Medical Device Regulation (MDR) does not just define requirements for the device (Annex I), it also defines the requirements for the documentation itself (Annex II). This must include:
- Identification of the device (e.g. with a UDI)
- Description of the device, including variants, configuration and accessories
- intended use
- Labeling (packaging, instructions for use, etc.)
- Information on the design and manufacture of the device
- Risk management file
- Verification and validation of the device and, therefore, proof that the device meets the general safety and performance requirements.
The MDR goes one step further: It includes the post-market surveillance, with its planning and implementation, under technical documentation. It establishes the corresponding requirements in Annex III.
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