Technical documentation for medical devices
Every medical device, including active and non-active medical devices, implantable medical devices and in-vitro diagnostics, is described in a Technical Documentation. The requirements for a Technical Documentation according to MDR/IVDR have increased. The contents of a Technical Documentation are defined in Annex II of the respective regulation. In addition, there are requirements in DIN EN ISO 13485 for product or development documentation in the form of a development file or a medical device file. Many of our clients are unsure what exactly belongs into the technical documentation and how best to manage these different files. The answer from our experienced consultants is usually that it is very individual and should be made risk-based. It also depends on whether you are a manufacturer or distributor of the medical device. There are requirements for technical documentation on the part of quality management, as well as on the part of product management or the development team. Last but not least, the technical documentation is the documentation of the final developed product, it includes risk management files, clinical evaluation, product description and many more contents. As soon as the product is adapted, relevant parts of the technical documentation must also be revised.
OBJECTIVES, PRINCIPLES, REQUIREMENTS OF A TECHNICAL DOCUMENTATION FOR A MEDICAL DEVICE
Objectives of a Technical Documentation
The manufacturer of a medical device must provide evidence of compliance with the regulatory requirements for the medical device during the approval process (or conformity assessment procedure) - as well as after the device has been placed on the market. In this context, the technical documentation serves to ensure that the safety and performance of the medical device is documented and verifiable, taking into account the applicable regulations. The following chapters are included (selection):
- Product description
- Intended purpose
- Classification
- Labels
- Instructions for use
- Packaging
- Specifications
- Risk management file
- Verification evidence
- Validation documentation
- Basic requirements
- Clinical evaluation
- Technical documentation on post-market surveillance
Basics and requirements by regulations of the technical documentation
The medical device manufacturer appoints a person responsible for creating and updating the technical documentation. According to MDR/IVDR requirements, this is usually done by the responsible person (see Article 15). This person is responsible for ensuring that all relevant information flows into the technical documentation and that it is regularly updated. The control of the documents (or records) of the technical documentation must also be regulated. Ideally, templates are available that are completed with each new product development. In case of further developments, improvements or optimizations of medical devices, the necessary documents are revised. It must be ensured that all documents that build on or refer to each other are always up-to-date and do not contradict each other.
Important regulations that you should consider for the technical documentation (if applicable)
- MDR/ IVDR
- DIN EN ISO 13485
- DIN EN ISO 14971
- DIN EN 62366
- DIN EN 62304
- DIN EN ISO 15223-1
- DIN EN 1041
QIP GMBH - YOUR PARTNER FOR THE TECHNICAL DOCUMENTATION OF YOUR MEDICAL PRODUCT
When preparing your technical documentation for your medical device, we can draw on the extensive experience of our staff in this field and related areas.
Exclusively for our clients, in addition to our team of postgraduate specialists, actively practicing physicians with their expertise in medicine, medical technology and medical informatics are available as consultants.
How you can benefit from our experience
- Review of your technical documentation, incl. evaluation in the form of a GAP analysis
- Creation of new MDR/IVDR-compliant technical documentation
- Revision of an existing technical documentation
- Participation in one of our seminars or webinars
- Experience of more than 30 years in scientific and clinical work
- Your technical documentation will be prepared by experienced staff with appropriate degrees (including promotion in the life sciences field).
- Based on our experience, we create your technical documentation quickly, in sufficient but not excessive scope, in a standard-compliant manner.
- We take over all related services in a highly qualified manner - we support you until successful completion.
QiP GmbH also ensures that you will receive an offer with a short-term project start immediately after receipt of your inquiry.
Time is money! - Save yourself unnecessary costs and secure your perfect market implementation with your safety-approved medical device by using our service.