Overview — NI's unique dual-market position
Northern Ireland's unique position within the UK medical device regulatory landscape — why EU MDR and EU IVDR apply in NI, what this means for manufacturers, and where to find more information.
The Windsor Framework — what changed in 2023
The Windsor Framework agreed in March 2023 replaced the Northern Ireland Protocol — what changed for medical device regulation in NI, and what remained the same.
Rules applying in Northern Ireland
The specific EU regulatory rules that apply in Northern Ireland — EU MDR 2017/745, EU IVDR 2017/746, CE marking, EU Notified Bodies, and EUDAMED registration.
UKCA marking and Northern Ireland
The relationship between UKCA marking and the Northern Ireland market — why UKCA is not accepted in NI, the UKNI indication, and what CE-marked devices can and cannot do.
Practical compliance for multi-market manufacturers
Practical regulatory strategies for manufacturers placing devices on both the GB and NI markets, or on GB, NI, and the EU — covering registration, marking, conformity assessment, and vigilance.