Journey Step 1 of 5
Check 1: Is your device correctly classified?
Confirm your device classification is still correct. Review if you have changed the device's intended purpose, added new indications, or modified its invasiveness or duration of body contact.
SaMD manufacturers: Note that MHRA will reclassify most SaMD to Class IIa minimum (expected 2026). Plan for UK Approved Body involvement if you are currently self-certifying as Class I.
Classify your medical device for the GB market
How to classify your medical device under the UK Medical Devices Regulations 2002. Covers Class I through III for general devices, active implantable devices, IVDs (current Annex system and future Class A-D), and Software as a Medical Device.
Read the guide →