On 12 October 2018, the MHRA issued Guidance for products without an intended medical purpose (Annex XVI) under the new Medical Device Regulation (EU 2017/745) providing guidance on the expansion of scope of the medical devices regime to include certain products which had been previously unregulated at EU level.

Article 1(2) of the Medical Devices Regulation (MDR), in force from 25 May 2017, explains that the MDR will regulate “certain groups of products without an intended medical purpose” as though they were medical devices.

There are currently six types of products in this category which are listed at Annex XVI of the MDR.

Continue Reading New MHRA guidance on non-medical devices