
Regulatory & Compliance
MDR/UKCA gap assessment: what it covers and when you need one
If you’ve got a medical device with some history behind it, perhaps a technical file written under the old directives or documentation inherited from a

If you’ve got a medical device with some history behind it, perhaps a technical file written under the old directives or documentation inherited from a

Class I is the lowest risk class under the UK Medical Devices Regulations 2002, and it covers a surprising amount of ground, from walking aids