Medical device and in-vitro device regulations have been in force for several years. There’s been
several occasions where device manufacturers have met notified bodies and/or competent authorities
and tried to discuss same topic with different terms. There’s been even situations where manufacturer
has been rewarded with non-conformance, if, for example quality contract, has not following the
terminology in regulations. I’d like to challenge the requirement using the exact same terms and
wording as it is written in the regulations.

Everyone, who has read the regulations, has faced the fact that it requires legal professional to
understand everything what’s included in the requirements. And still there is room for interpretation.
When we think about the nature of medical device manufacturers, majority of those are small or
mid-size companies who don’t have legal advisors as part of their organization, so they must
buy that expertise and we all know that it’s not very cheap. Which leads to situations that
interpretation is made by non-legal people. And here comes the challenge with terminology.

Quality contracts are simple example of files, which is typically are signed by medical device
manufacturer and supplier. In many cases supplier is not medical device expert and quality
contract might be the first time when they see these tricky terms coming from regulations.
The purpose of the quality contract is to agree common practises how to make medical devices
in cooperation with good quality and ensure the safety of the devices. If we are using here
the regulatory terms, it might lead to situations where the other party do not understand the
content of the quality contract and some fundamental requirements might be understood
wrong way or totally ignored. And this would danger everything.

I would like to propose that common language should be allowed to be used in this kind of situations.
If the initial requirement is written with other terms than those introduced in regulations, that should
be acceptable if the meaning is still same. We do have people who have both legal and medical
device knowledge who can translate regulatory language to “normal” language and so ensure
that the requirements are still met. It should not be so, that using different wording would lead to
situation where notified body gives you a non-conformance just because the wording in the contract
is not same than in regulations.

Author: Hannele Toroi