Evaluation (Validation and Verification) - Medical Device Design: Innovation from Concept to Market - page 241

ISO 14155 makes it your responsibility as the sponsor that the study is conducted correctly
and that all relevant documentation is in place. You can delegate the responsibility of design
and action to a professional, but in the end you or your company have overall responsibility.

9.6.5 ISO 14155 and EC-FDA Guidelines
ISO 14155 is the overarching standard for clinical investigations of human subjects. If you
use this standard as the basis for your clinical study you will be meeting every requirement
of every regulatory body and, at the same time, ensuring you fulfill the requirements of the
Helsinki declaration. The EC has a clinical evaluation guideline, MEDDEV 2.7.1 ( EC, 2009 ),
in which clinical studies are referred to. The FDA guide is in the design control guide ( FDA,
1997 ). However, working to the ISO will meet their respective requirements. Both have
detailed guidance as illustrated by Table 9.11 .

It is obvious that as technology improves the guidelines change and, as you can see in
Table 9.11 , they are constantly being updated. You should, therefore, keep a keen eye on these
guidelines as you do your standards portfolio. It is interesting to note that the FDA guidelines
do not refer directly to ISO 14155; however a scan of the guidelines makes it clear that
meeting ISO 14155 means you have, effectively, FDA requirements too. However, as with all
other regulatory statements, check first!

Table 9.11: FDA and MHRA Guidance Documents for Clinical Investigations

Title Body Published or Draft

1: Guidance for manufacturers on clinical investigations to
be carried out in the UK

MHRA Published

3: Information for clinical investigators MHRA Published

4: Pre-clinical assessment guidance for assessors MHRA Published

17: Guidance notes for manufacturers on statistical
considerations for clinical investigations of medical devices

MHRA Published

Design considerations for pivotal clinical investigations for
medical devices

FDA Draft

Investigational device exemption (IDE) for early feasibility
medical device clinical studies, including first in human (FIH)
studies

FDA Draft

The 510(k) program: evaluating substantial equivalence in
pre-market notifications [510(k)]

FDA Draft

Statistical guidance for clinical trials of non-diagnostic
medical devices

FDA Published

Guidance for the use of Bayesian statistics in medical device
clinical trials

FDA Published

FDA decisions for investigational device exemption clinical
investigations

FDA Draft