By James Heilman, MD - Own work, CC BY-SA 4.0, https://commons.wikimedia.org/w/index.php?curid=34056919

Ventilator Projects and EMC Regulations (UK)

SUMMARY:

1. CE marking probably won’t be necessary for UK for temporary ventilators
2. Still need to apply to MHRA for permission to use in clinical setting
3. This will likely involve the supply of test data to MHRA
4. The requirement for EMC testing is currently To Be Confirmed
5. U3C will give any ventilator design a pro bono EMC design review

In the current Covid-19 pandemic there are many project teams around the world coming up with designs for ventilators. The potential is for many such devices to be required.

The problem that this article identifies is that for normal medical devices, the length of time taken to get products approved is defined in terms of months. This is especially true for ventilators which are, according to several sources, a Class IIb device requiring a robust quality system and Notified Body approval.

The current requirement is for devices to be delivered within weeks.

Recognising this, the MHRA in the UK have published a “Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak.”

Interesting points from this document in relation to the Electromagnetic Compatibility (EMC) characteristics are:

Page 10: “2. It is not anticipated that devices will be CE marked and approval by the MHRA will be through the “Exceptional use of non-CE marked medical devices” route (https://www.gov.uk/guidance/exceptional-use-of-non-ce-marked-medical-devices)”

The procedure covered under the “Exceptional use of non-CE marked medical devices” involves applying to the MHRA directly for a pass to supply this product for use without CE marking. This request will have to include data that shows compliance with the test criteria in Appendix B of the MHRA specification.

Page 11:3. When the current emergency has passed these devices will NOT be usable for routine care unless they have been CE marked through the Medical Device Regulations. The device must display a prominent indelible label to this effect.

Page 24: “EMC Testing (TBC): Must comply with IEC 60601-1-2:2014, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests”

Note that the requirement for EMC testing remains TBC = To Be Confirmed. I strongly feel that at least some testing should take place, but functionality of the ventilator has to come first.

Next article will be a breakdown of the EMC test requirements called up in EN 60601-1-2:2014. I’ll also highlight some risk areas that designers of these ventilators will need to to bear in mind.

If anyone has any need for pro bono EMC design review services for ventilator projects or needs some EMC testing turning around quickly then get in touch.

hello@unit3compliance.co.uk

I hope you are all keeping well during these interesting times.

James