What is the harmonized standard?
Last month, we discussed clinical evaluation and clinical investigation, during which we also touched on the ISO14155:2020. This month, we’re going to dive into this even further. The ISO14155:2020 is recognized as an harmonized standard. In accordance with Article 5(1) of the Council Directive, all EU member states should aim to follow certain harmonized standards.
What exactly is meant by the term harmonized standard?
In order to understand the harmonized standard, it’s important to first understand what the term standard means in the medical device field as this can often be the first point of confusion.
In the medical field, standards are technical documents. They provide specifications, guidelines, and requirements which should be used as much as possible in order to ensure that all materials, products, processes, and even services are fully fit for their purpose. The use of standards help ensure product safety and quality, but they can also help in lowering costs and prices.
What about these so-called harmonized standards?
Simply put: the harmonized standards are the basic requirements that every manufacturer developing a medical device for the market should follow. They are used to demonstrate that the products and devices being put out on the market all comply with EU legislation. They are harmonized because the standards expected are uniform across all of Europe. Harmonized standards are recognized by the MDR after they are published in the Official Journal of the EU.
Now these terms are starting to make more sense, but it can lead to a follow-up question:
Who determines these standards?
The harmonized standards are regulated by the CEN and Cenelec. They are regularly revised and updated as rules and regulations change. One year ago, the ISO14155 was updated. Some of the new changes to the ISO14155:2020 include:
- Registration of clinical investigation must be published in a publicly accessible database
- Guidance for clinical investigation audits
- Reinforcement of risk management through the process of a clinical trial
We will dive into the key changes of the ISO14155 2020 version in the next article. So stay tuned.
As a medical device manufacturer, what exactly does this mean for you?
Do you need to concern yourself with the ISO14155:2020? Absolutely you do.
Last month, we talked about the role that clinical investigations and clinical evaluations play in the MDR (if you haven’t read it yet, now is a great opportunity to have that necessary context). Well, the ISO14155:2020 is directly related to the MDR. The current ISO14155 was specifically updated to meet the current requirements of the MDR.
Conclusion
While the harmonized standards are voluntary to use, using the appropriate standard demonstrates that you confirm with the general safety and necessary requirements (both legal and performance) as stated in the MDR. And, if your device is not compliant with the MDR, this can lead to a series of serious issues for you later, so it is absolutely something that you need to keep on top of.
The MDR, in general, can be difficult to understand since there are so many different elements to it. If you find that you are having trouble understanding, could use some guidance or would benefit from training, contact Rianne Tooten.
