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FDA Quality System Regulation and ISO 13485

A ray of sunshine has appeared for medical device developers seeking to market their devices in the US as well as other territories.

Often, manufacturers wrestle with ensuring that their development process, activities and documentation aligns with both ISO 13485 and the Quality System Regulation (21 CFR 820).

US FDA has announced plans to harmonise the requirements contained in 21 CFR 820 with the content of ISO 13485:2016.  There is planned to be a fundamental revision to part 820, that will “supplant the existing requirements” with the content of the revised 13485 standard.  The agency intends the changes to reduce the compliance and record keeping burdens on manufacturers.

For the canny development organisation, little will actually change, as they will have planned their activities to achieve compliance with both the US and other territories requirements at the same time.  FDAs intentions will make their lives a little easier, removing the need for  translations between, for example document names, from the standard and part 820 terminologies.

For people embarking upon development with an eye on the US market for the first time, there’s likely to be one less hurdle to surmount once FDA’s intentions bear fruit.

Ultimately, the plans are good news for manufacturers who develop and market products for the EU, Japan, Canada, Australia (and the US), as all have regulatory requirements aligned with a single Quality Management Standard – leading to a reduction in compliance requirements for manufacturer Quality Management systems.

You may be thinking about seeking reassurance that your medical device development plans adequately address the regulatory requirements of the US and ISO 13485:2016 aligned regulations.  Get in touch with our team today.


Is it “wellness”, or is it a device? Software as Medical Devices in the EU

The buzz surrounding the development and use of smartphone apps and other software to “manage healthcare” and “wellness” isn’t going away any time soon.

It is a situation that creates significant headaches for people developing software that may, or may not, be viewed as (part of) a medical device. Uncertainty that presents significant risk to their development plans, activities and investment, especially when the software part of the product sits on the cusp of the medical device space.

Earlier this year, we discussed how the FDA’s approach to this rapidly evolving market segment was bringing clarity (if you’d like a refresher, you can read the article here).  Let’s turn now to the approach taken in the EU.

EU treatment of software as a medical device

Developers have often referred to the MEDDEV Guidelines, as tools to help interpret the requirements of directives/regulations for medical devices.  The guidelines have been regarded as just that, and not legally binding – so there hasn’t been certainty over how well they interpret EU law.  But, now there is a legal ruling from the EU Court of Justice (CJEU) on the grounds for classifying software as a medical device.

Essentially the CJEU ruled that software is a medical device if it has at least one functionality that allows its use for a medical purpose set out in the definition of a medical device in the MDD (as amended):

  • Diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • Investigation, replacement or modification of the anatomy or of a physiological process,
  • Control of conception

The software does not have to work directly in or on the human body to be classed as a medical device.  The purpose of using the software is important, rather than the manner in which an effect is produced to the human body.

Why this should matter to you

The CJEU decision validates the criteria in MEDDEV guidance for classification of software medical devices, so they can be relied on with greater confidence both by the industry and regulatory authorities.  Developers of medical devices that are entirely or partly software can use the MEDDEV decision tree with confidence.

Determining if Software is a Medical Device or IVD

MEDDEV 2.1/6 includes a handy decision tree to help you determine if your software is a medical device:

Click to enlarge

There’s a similar decision tree to help you determine if your software is an in-vitro diagnostic device:

Click to enlarge

As you might expect, the devil is in the detail, for both of these classification routes.

Reducing and Managing Risk

The CJEU ruling means that development projects can have a greater degree of confidence that they’re applying the correct classification to their products, and hence massively reduce the risk that their activities are inadequate to satisfy regulatory authorities. The ultimate benefit is in avoiding unnecessary costs, unwarranted testing and use of resources, whilst ensuring that, for those software that are truly medical devices, sufficient testing and documentation are provided to demonstrate regulatory compliance.

You may find it useful to seek an independent, expert opinion on the outcome of using the decision trees for classifying your software development, before embarking on an expensive and lengthy programme.

If you would value a conversation to get the ball rolling, get in touch with us today.


Wishing you a happy holiday season

Wishing all of our friends, colleagues and clients a great Christmas, New Year and a wonderful start to 2016.  Merry Christmas reindeer smaller - dreamstime


Our offices are closed from 23rd December until 5th January 2016.

See you next year!