5 docs tagged with "northernireland"

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.

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.

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.

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.

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.