IVD Directive Essential Requirements Checklist
The 8 Step Essential Requirement checklist for IVD Directive. The IVDR EU 2017/746 is responsible for governing the regulatory market access for in vitro diagnostic (ivdr) medical devices. It also includes the requirements for each device’s technical documentation. The information can vary based on the classification of the device, but it is always the main piece of evidence within the essential requirements.
If your medical device holds a CE marking and will be on the EEA market, then it must have a technical file. It’s important to note that even if your device has not gone through a notified body, the evidence must still be present. This is because some authorities will review the technical documentation regularly.
The technical file must include specific information regarding the general safety of the medical device. The documentation must at least meet the requirements, if not exceed them. You must ensure that each medical device meets each and every one of the requirements.
Here is the checklist for IVD Directive that you should include in your technical file
Design Information & Calculations
Annex III.6.1 also states that some additional information must be included in the technical documentation
- Test reports
- Self-testing proof data
- Instructions for Use (IFU) information
Stability must be considered, this includes the storage and transportation of the medical device. For example, if it must be kept in colder temperatures. These tests are usually completed in real time conditions.
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