Conformity assessment — overview & route selection
How conformity assessment works under the UK MDR 2002 — the available routes by device class, the role of UK Approved Bodies, how to select the right route, and what the process produces.
Class I self-declaration pathway
How manufacturers of Class I medical devices self-declare conformity under the UK MDR 2002 — the process, required documentation, MHRA registration, and the three Class I sub-categories that require partial UK Approved Body involvement.
Class IIa · IIb · III — UK Approved Body routes
The UK Approved Body conformity assessment routes for Class IIa, IIb, and III medical devices under Schedule 3 of the UK MDR 2002 — QMS audits, type examination, design dossier assessment, and the certificate types issued.
UK Declaration of Conformity
What a UK Declaration of Conformity is, what it must contain, who signs it, how it differs from an EU Declaration of Conformity, and how to maintain it throughout the device lifecycle under the UK MDR 2002.
CE marking — transitional acceptance in GB
How CE marking is accepted on the Great Britain market under transitional arrangements — the current deadline of 30 June 2030, what devices are covered, the conditions that apply, and what manufacturers must still do even when relying on CE marking for GB access.
UKCA marking requirements
How to correctly apply the UKCA mark under UK MDR 2002 — who can affix it, what it must look like, where it must appear, the UKAB identification number, and the transitional CE marking acceptance for the GB market until 30 June 2030.