- Product overview (including variants)
- Description of the production process (including any cleaning / sterilization / commissioning / maintenance)
- Intended use (patient population, associated devices, and class of belonging)
- Design specifications (functional and performance requirements / safety requirements / applicable standards / risk analysis)
- Control and verification techniques of the design results according to ISO 13485
- Validation and verification of essential requirements (in case of associated device)
- Manufacturer's declarations
- Security Solutions
- Preclinical evaluation: in vitro and animal tests
- Clinical evaluation
- Label design and package insert (fixed and variable data)
- The following must be attached to the Technical File:
- technical drawings and list of variants
- accessories list
- risk analysis
- clinical investigation
- check-list of essential requirements (essential for the assessment of conformity to issue the certification by the Notified Body)
- declaration of conformity
What are the criteria for classifying a medical device according to the Medical Device Directive?
Classes are divided by device complexity and potential patient risk. The duration of contact of the device with the human body, its invasiveness, the anatomical site, and its dependence on energy sources are also considered.
- Class I: less critical, non-active, and non-invasive DM
- Class IIA: DM at medium risk, DM that interact with the patient in a non-dangerous way
- Class IIB: DM at medium/high risk, DM that interact with the human body in a dangerous way
- Class III: high-risk, implantable DM containing drugs, animal derivatives, which interact with vital functions.
