Applicable Great Britain regulations for a custom-built test rig or evaluation kit used for research purposes only.

[jansayshello]

Hello,

I hope someone can help.

The company I work for (medical device designer and manufacturer) is developing a test rig/system for a customer for the purposes of research and development in a university/R&D environment in Great Britain only.

It is intended to eventually be used in a research study by a small number of university test participants (masters students).

It is NOT intended to be placed on the market or used by "consumers" or lay persons in its current form.

It is NOT intended to be used without supervision.

Without revealing any of the IP, it involves "measurement" of certain muscular forces applied by athletes and incorporates a mechanical framework, force sensors, a rechargeable-battery control hub to relay the data from the sensors via Bluetooth, and an off the-shelf tablet PC to receive and display that data in an app in real time.

The tablet PC and its power supply are both CE-marked.

The low-voltage control hub battery can be recharged from a 5V DC USB port on the tablet PC when the device is not being used.

It does NOT qualify as a "medical device" based on its intended use and the definition of a medical device from the UK medical devices regulations 2002 (S.I. no. 618).

It does NOT qualify as a "measuring instrument" based on its intended use and the definition from the Measuring instruments regs 2016 (S.I. no. 1153).

It is excluded from the scope of the radio equipment regulations 2017 (S.I. no. 1206) based on regulation exclusions, as it is a "custom-built evaluation kit destined for professionals to be used at R&D facilities solely for R&D".

It is excluded from the scope of the Electrical Equipment (safety) regulations 2016 (S.I. no. 1101) based on regulation exclusions, for the same reason.

It is excluded from the scope of the EMC regulations 2016 (S.I. no. 1091) based on regulation exclusions, for the same reason.

It is excluded from the scope of the WEEE regulations 2013 (S.I. no. 3113) based on regulation exclusions, for the same reason.

It is excluded from the scope of the RoHS regulations 2012 (S.I. no. 3032) based on regulation exclusions, for the same reason.

We think that it might not qualify as a "product" based on the General Product Safety Regulations 2005 (S.I. No. 1803) as strictly speaking the end-user in the research study is not a "consumer" and the system is not intended to be placed on the market.

The regulation definition of a "product" is:

"'Product' means a product which is intended for consumers or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them and which is supplied or made available, whether for consideration or not, in the course of a commercial activity and whether it is new, used or reconditioned and includes a product that is supplied or made available to consumers for their own use in the context of providing a service."

QUESTIONS

1. From a purely legal perspective, are there any GB regulatory frameworks that would apply to this device/system?
2. Or do you think we are wrong about the GPSR 2005 above, and that the test participants are "consumers", and that the GPSR 2005 applies?
3. Or is it just the case that this sort of research equipment is unregulated in Great Britain and common sense applies to make sure users are free from unacceptable risk of harm?

As an aside, we have applied risk management during development and identified applicable standards that could be used to demonstrate safety – however full application of these standards appears disproportionate to the risk of harm involved, especially as these standards don't perfectly "fit" with what the device/system is.

Thanks in advance!

Jan.