Anyone involved with clinical investigation should have a copy of the ISO 14155:2020 standard because it contains everything that is needed on good clinical practice, GCP. But it can be expensive if you buy it in the wrong place.
In this article, you will learn where to buy the standard for a fraction of the price compared to major outlets.
The official ISO website offers PDF, EPUB, redlined, and paper format, and combinations of those for the following prices:
Format | Language | Price |
---|---|---|
PDF+EPUB
|
English / French
|
CHF 198 (EUR ~189)
|
PDF+EPUB+REDLINE
|
English / French
|
CHF 238 (EUR ~227)
|
PAPER
|
English / French
|
CHF 198 (EUR ~189)
|
There are also other places where you can get access to the ISO 14155:2020, such as:
- ANSI (EUR 200-300 depending on the language and format)
- Swedish Standards Institute (EUR ~210)
- British Standards Institution (EUR ~340)
The good news is that there is a more affordable option and that is buying a copy from the Estonian Centre for standardisation and accreditation. The price there is much lower than on the official ISO website or elsewhere. And the standard is still in English.
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
|
|
PDF
|
EUR 26.58
|
PDF+REDLINE
|
EUR 31.90
|
PAPER
|
EUR 26.58
|
Would you like to know more about Clinical Investigation?
Take a look at our online Clinical Investigation for Medical Devices and ISO 14155 course that focuses on good clinical practice (GCP) for the design, conduct, recording, and reporting of clinical investigations carried out on human subjects to assess the clinical performance or effectiveness and safety of medical devices.
The course covers an orientation of the clinical investigation process according to the EN ISO 14155:2020 standard and the standard’s relation to MDCG guidance documents. This practical course is suitable for anyone working in clinical research and medical device development, such as regulatory affairs associates, QA engineers, and clinical research specialists.

Maria Nyåkern
Maria Nyåkern, Ph.D., is a consultant, entrepreneur, and B2B service provider in the medical device industry; she is the founder of AKRN Scientific Consulting, a CRO specializing in medical devices and minimally invasive cardiovascular therapies.
Maria is also a valued and respected trainer on clinical evaluation and clinical investigations of medical devices according to the EU MDR 2017/745 and the ISO 14155:2020 standard. She has vast ‘ hands-on’ experience, having set up and managed dozens of clinical investigations, and tens of thousands of patients, for different medical devices and indications for many of the top ten medical device manufacturers in the industry.