Technical Files for Medical Devices:
Prove your device’s safety, efficacy and performance.

You know that phrase, if it isn’t documented, it doesn’t exist?

A medical devices technical documentation is how you demonstrate the safety, efficacy and performance of the device under evaluation. It is an auditable record that will be looked at extremely closely for the lifetime of your device (and possible longer).

It proves the standards your device is designed and manufactured in line with, the biological and clinical safety, risk management as well as suppliers utilised within its manufacturing. Regardless of where you are selling, technical documentation is key to becoming registered in any regulatory jurisdiction.

Here are some tips I shared on the Easy Medical Device Podcast with my friend Monir on the most common Technical Documentation inconsistencies I see.

Well-organised technical documentation creates traceability through the device’s history that lowers the burden during an audit or inspection. It is useful in the change control process by identifying related requirements and documents that may be affected by a proposed design or process change. Establishing the DHF/TF also preserves design-related information within the business and ensures that accurate and up-to-date information on the design is passed around to employees

I’ve also generated a guidance document that you can use as a technical file contents checklist for medical devices. You can find this at my newsletter here - https://theotherconsultants.substack.com/p/review-your-technical-documentation

What are Technical Documentation Requirements

Technical Documentation requirements will change depending on what territory the device is looking to be cleared for.

If you are looking to place a device on the market in the UK, at the moment it is still under the current EU MDD (93/42/EEC), but if you are looking to place a deviceo n the market in the EU then you will have to comply with Annex II or EU MDR and EU IVDR. Below is a summary of the requirements from EU MDR as a guide to highlight the overview requirements:

  • Identification of the device (e.g. with a UDI— Unique Device Identifier)

  • 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

  • A 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 further and includes post-market surveillance (PMS), with planning and implementation, under technical documentation. It establishes the corresponding requirements in Annex III.