This website/blog is dedicated to what has become known as the 'software medical device' (SaMD), which is effectively a legal term as defined in both EU and US medical device regulations. In simple terms, a software medical device is defined as software that is intended to be used for one or more medical purposes without being part of a hardware medical device.  

 

Regulatory control of medical software development is very much a hot topic as regulators struggle with the issues of attempting to oversee and control a complex and error prone development process. There is a particular emphasis on the in-house development of medical software by hospital staff and how recent changes in EU and US medical device regulations will affect them.

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In the United States the regulation and enforcement of federal law covering medical devices is the responsibility of the Food and Drug Administration (FDA). You will sometimes hear people speak of "FDA regulations", but this is slightly misleading. The regulations themselves are usually in the form of a Code of Federal Regulations (CFR) and the one covering the activities of the FDA is called Title 21. For example, 21 CFR part 820 (also known as the 'quality system regulation') outlines current Good Manufacturing Practice (GMP) that cover all aspects of medical device manufacture.

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The EU Medical Device Directives (originally published in the early 1990s) have now been replaced by the 2017 Medical Device Regulation ('MDR17'). The new regulations clarify and tighten some aspects of regulatory control and include specific requirements for healthcare staff who develop their own medical device software - even if it is only for use within their own institution. This represents a significant change for many scientific and technical staff for whom software development has been a 'side line' to their main clinical and managerial responsibilities. Hospital departments that undertake medical software projects should now be re-assessing this activity in light of the new regulations.

 

NOTE: The 3-year transition period was originally due to end in May 2020, but was extended by 12 months in view of the disruption caused by the COVID-19 pandemic. New UK medical device regulations are now not expected until June 2025 (i.e., 2 years later than originally planned). In the meantime, the 2002 UIK Medical Device Regulations (suitably amended) are still in force in GB.

 

The new requirements for continued in-house development of medical software are discussed here.

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Just before we proceed, you might reasonably ask what qualifies me to publish a website on this subject?

Well, I recently retired from the NHS having worked for nearly 40 years as a clinical scientist in the areas of Medical Physics and Radiology. Thirty of those years were spent at Head of Department level, so I have experienced all the trials and tribulations of NHS management too.

 

My interest in medical software development (mainly image processing) started way back in the 1980's. Apart from being taught the basics of FORTRAN at university, I am a largely self-taught computer programmer (Assembler, BASIC, VBA, C++, Python) but my main interest has always been in software quality assurance. I attended one of the first major conferences following the publication of the EU Medical Device Directives and have been closely involved in advising UK medical physics colleagues on the implications ever since.

 

In the early 1990's I was one of a small team representing in the UK on two major EU projects; one ('COST B2') on quality assurance of nuclear medicine software and a more general one ('QAMS') on QA of medical software. More recently, I have written or co-written chapters for IPEM publications on quality control of gamma cameras and associated computer systems (IPEM Reports 86 and 111) and I was a member of IPEM's software development working party between 2015 and 2017 that published a series of articles in Scope (see publications page).

 

Over the years I have given numerous invited talks at medical conferences and had fruitful professional contact with the UK's MHRA, the NPL, experts in IT law, and also private companies involved in the testing and certification of software.

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I hope you enjoy browsing the site and learn something useful from it. 

 

 

 

 

 

 

This site went live on 20 October 2018

 

This page was last updated: 01 April 2024

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