I have 13485 — Do I need “harmonized standards”?
The term harmonized standards is officially used in European law. To meet European product laws such as the Medical Device Directive (or Active MDD or In-vitro MDD) an organization must meet the requirements laid down in the directive itself. In order to make that easier (legislation is written in legalize and not technical language) the European Union officially recognizes international and National standards that specifically meet legislative requirements. These standards are then termed “harmonized”. The most common example is ISO 13485 itself. There is no requirement in the MDD to actually meet 13485 but if an organization can demonstrate that it does meet 13485 then it is considered to fully meet the some of the requirements of the MDD.
The principle goes further. Europe recognizes that certain standards, which if adopted and met, will address other
requirements. Many of these standards are detailed technical standards and address a “few” requirements within the legislation. A complete technical standard might cover testing and validation of toxicity and address a single line in the legislation that says “ensure the product is not toxic”. As time goes on more and more technical standards are recognized as meeting requirements and more and more become harmonized.
Although there is not a downside, in some instances the harmonized standards may be overkill.
For instance, IEC 62304 – medical device software – software life cycle processes, is a standard for how software should be developed for medical devices. If your device is simple and perhaps you are the only developer then a formal lifecycle process is not necessarily appropriate, although the principles are still valid.
It is important to note that technically harmonized standards are not mandatory. If you have a simple way to prove that your product is “not toxic” or that “software is developed under controlled conditions” then you don’t need to address a full standard.
It is also worth noting that notified bodies are keen to encourage the use of harmonized standards and it is likely that all relevant standards will be identified for your device and you will be quizzed about their applicability. Adherence to standards shows a comprehensiveness of approach and the notified body doesn’t need to challenge themselves and think about adequacy – because the standard is defined as adequate. Given this it is important that you look for harmonized standards, review them and are at least able to comment of their applicability.
Finally its worth noting that the concept of harmonized standards is actually adopted more widely including in Canada and the US.
Here is the link for Health Canada (it’s easiest to then click on the link for “List of Recognized Standards” and then click on the pdf view): (Oct 2011)
And here is the US FDA’s link: (Oct 2011)
They expect you will extract from their list all that are applicable to your device.
Cavendish Scott helps organizations implement ISO 13485 management systems and assists with the preparation of device technical files including formats to address legislative requirements including through harmonized standards.