What is ISO 13485?
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 is iso 13485 in plain English?
To put it simply, ISO 13485 is a standard created by the International Organisation for Standardisation (ISO) for manufacturers of medical devices to implement Quality Management System (QMS) requirements.
The standard is internationally recognised by the EU as a harmonised standard, the UK as a designated standard and the USA now under the Quality Management System Regulation (QMS) as a consensus recognised standard.
It provides one framework that a manufacturer can use to implement QMS requirements, this makes it easier for that manufacturer to demonstrate compliance to the relevant QMS requirements of a relevant regulatory jurisdiction. Let’s look at an example:
Regulation 2017 / 745 also known as EU MDR…the QMS requirements are document in Article 10 (9) of the regulation.
So, a manufacturer can work to ISO 13485, providing a simpler way to implement requirements, and because the standard is harmonised as EN ISO 13485:2016+A11:2021 - it makes things easier, so the Notified Body (NB) will presume conformity to the standard, and assess according to the EN ISO 13485:2016+A11:2021.
Note: Just because ISO 13485 is used to implement QMS requirements, does not mean the organisation is automatically compliance to regulatory requirements. Each part of the regulation shall still be able to be traced to conformity.
Manufacturers with an existing ISO 13485:2016 Quality Management System (QMS) must still address specific aspects of the new Medical Device Regulations (MDR) and In Vitro Diagnostic Medical Device Regulations (IVDR). These may include identifying applicable General Safety and Performance Requirements (GSPR), developing a regulatory compliance strategy, and implementing Unique Device Identification (UDI) verification.
The EU Regulations have also refined or clarified existing requirements, such as incident reporting timelines. To ensure compliance, manufacturers are advised to refer to EN ISO 13485:2016+A11:2021. This harmonized standard's Annexes ZA and ZB provide a valuable comparison between ISO 13485:2016 and the MDR/IVDR requirements, aiding in QMS adaptation.
For manufacturers previously exempt from QMS requirements, this standard can also serve as a valuable guide for establishing a robust system. However, it's crucial to note that certification is not mandatory for devices falling outside conformity assessment routes requiring Notified Body involvement.
The QMS should be implemented effectively and proportionately, considering the device's risk class and type.
Is ISO 13485 mandatory?
Strictly, it is not mandatory - although a lot of notified bodies and certification bodies will lead you to believe otherwise. It does however, make life WAY easier.