Technical documentation for medical devices
The technical documentation for medical devices comprises all documents that the manufacturers have to provide in order to subject their medical devices to a conformity assessment . You need the technical documentation in order to be allowed to bring a medical product onto the market and to be able to certify the quality management . Legal requirements result from the Medical Devices Act .
Role of technical documentation in quality management
The technical documentation, also known as the "Technical File", is written by the manufacturers to accompany the development. The technical documentation for medical devices is first submitted to the notified bodies (independent testing and certification body) for review. The technical documentation is usually a subject of the ISO 13485 audits. On the basis of this documentation, the auditors check whether the requirements of the Medical Devices Directive have been complied with and whether the manufacturers are working in conformity with their own quality management system. The medical devices are developed and produced with the help of the QM system processes. On the basis of complete technical documentation, medical device manufacturers can prove that their medical device fulfills the basic requirements and that their QM system is effective. For many manufacturers, the QM system is a prerequisite for conformity assessment.
Typical structure
Various organizations and notified bodies publish recommendations regarding the structure of the technical documentation.
- Product description
- Intended use / indications
- Side effects / contraindications
- List of items that can be used in combination / description of interfaces
- Classification (guideline / rule)
- Instructions for use / package insert
- Product identification (labeling)
- Essential requirements checklist
- List of applied standards
- Risk management file
- Technical specifications
- Drawings / specifications / parts lists
- Manufacturing instructions and work plans
- Test instructions
- Verification and validation protocols as part of development
- Packaging definition
- Clinical test / proof of effectiveness
- Usability
Conformity assessment procedure
The manufacturers of the medical device determine the conformity of the technical documentation with the basic requirements of the European directives during the conformity assessment. A complete quality assurance system according to ISO 13485 is required to enable a conformity assessment.
Individual evidence
- ↑ https://www.johner-institut.de/blog/tag/technische-dokumentation/#bedeutung , accessed on May 3, 2016
- ↑ http://www.tuev-sued.de/akademie-de/seminare-gesundheitwesen-und-medizintechnik/medizintechnik/manager-regulatory-affairs-international-tuev/4611003/technische-dokumentation-fuer-medizinprodukte-2016# , accessed on May 3, 2016
- ↑ https://www.johner-institut.de/blog/tag/technische-dokumentation/#bedeutung , accessed on May 3, 2016
- ↑ NB-MED / 2.5.1 / Rec5. Notified Bodies Medical Devices, accessed January 4, 2017 .
- ↑ Guidance Technical Documentation. TÜV SÜD, accessed on January 4, 2017 .
- ↑ https://www.johner-institut.de/blog/tag/konformitatsrechner/ , accessed on May 3, 2016
- ↑ https://www.zlg.de/index.php?eID=tx_nawsecuredl&u=0&file=fileadmin/downloads/ab/309-0600-A03.pdf&hash=5d3034230d46adde41887f2920d8dcf3d435df7d , accessed on May 3, 2016