Software in Medical Devices, by MD101 Consulting

After a temporary absence, I'm back on the waves with a new series of articles to talk about the files required by the 21 CFR 820 regulations:

• DHF: Design History File,
• DMR: Device Master Record,
• DHR: Device History Record.

Let's begin with the DHF.

MHRA, the regulatory authority of the UK, published in march a guidance on medical device standalone software.
This guidance is a prime source of information about software in medical devices in the European Union. It gathers all existing information about the way medical device software is regulated in the EU.

In the last article, we explained why agile methods are so popular for mobile app software development. Today, we are going to review a major characteristic of mobile platforms: wireless connection.

The last time I updated my essential list of guidances was in 2012. Today I've done a full refresh of that page with:

• Change of GHTF to IMDRF,
• Update of links to TEAM-NB website,
• Update of FDA guidances, especially the brand new guidance about mobile medical applications.

I hope you'll find all relevant regulatory information about software on that essential list of guidances.

FDA recognizes 25 standards about risk management, interoperability and cybersecurity.
More on AAMI news website and the link to the Federal Register notice of Aug 6, 2013.

At be beginning of june 2013, the International Medical Devices Regulators Forum (IMDRF) published a proposed document on standalone software definitions.
The goal of this document is to harmonize the key definitions related to standalone software.

Unique Device Identification (UDI) had been in the pipes of regulators for a few years, beginning with the US in 2007, and following (as usual) by the European Union a few years later in 2012.
In parallel, the International Medical Device Regulators Forum (IMDRF) issued in 2011 a guidance on UDI, with the honorable objective of harmonizing UDI's all over the world.
What is the impact of these regulations and guidances on medical device software?

A few words about guidances in Europe. News are rare enough to point them out.
First, the guidance on electronic labelling came into force on 1st march 2013, see the MHRA website for some explanations and the original decision on the EU website.

Too busy to write a long post this week.

I've not talked about a new FDA draft guidance yet:
The Draft Guidance for Industry and FDA Staff - Design Considerations for Devices Intended for Home Use.

Though not specific to software, this guidance has consequences on software design of medical devices for home use. The design team has to watch for problems linked to the users, their diseases and their environment where things can get messy.

Most of the content of that guidance is not intended to be applied specifically to software. But it contains a few elements that are applicable to software, mainly alarms, human factors, and use of device in emergency. That is another way of saying that ergonomics and human factors engineering are important input data for software development.

Here is the second part of my last article about EU Proposal of new regulation.