Would a proposed medical use need review through the MHRA route?

Would a proposed medical use need review through the MHRA route?

Regulation 2(1) of the Medical Devices Regulations 2002, SI 2002/618, as it applies in Great Britain, defines a medical device as “any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination”, with its accessories, which “is intended by the manufacturer to be used for human beings for the purpose of”, among other things, “diagnosis, prevention, monitoring, treatment or alleviation of disease”.

The company does not say how that definition applies to any proposed use. The company sets out its position under two bodies of law only, and neither of them is the law there.

Under United States law, NF Technical Products Inc. classifies the NanoFlashing™ Air Filter as a device under Section 2(h) of the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. § 136(h), and 40 C.F.R. § 152.500(a). Under Regulation (EU) No 528/2012, C-POLAR Technologies, Inc. classifies the same filter as neither a biocidal product nor a treated article. Each statement records that it addresses that one question only. No authority has approved, registered, endorsed or cleared the filter; the company classifies its own article.

What an authority requires of a product placed on its market is decided under its own rules, by the party that places it there. Every commercial NanoFlashing™ product is made by a manufacturing partner, in their facility, in their format.

Source: Statement of Classification for the NanoFlashing™ Air Filter, sections 1.3 and 3.7, issued by NF Technical Products Inc.; Statement of Regulatory Status for the NanoFlashing™ Air Filter, sections 1.3 and 3.7, C-POLAR Technologies, Inc., 11 September 2026; C-POLAR — Terms of Use, section 6, https://cpolar.tech/terms/; Medical Devices Regulations 2002, SI 2002/618, regulation 2(1), Great Britain version, read 20 September 2026, https://www.legislation.gov.uk/uksi/2002/618/regulation/2.

Reviewed on 21 September 2026.