The European Medical Device Management System has been upgraded from Directive MDD(Directive 93/42/EEC for Medical device) to Regulation MDR(Medical Device Regulation (EU) 2017/745). With the introduction of higher regulation MDR, Companies that have undertaken the work of certification bodies with existing MDD NBs should be re-evaluated by enhanced European authorities on NBs' designation crite..

Northern Ireland MDR/IVDR Nach dem 1. Januar 2021 ist die Behörde für die medizinischen Geräte in Nordirland weiterhin für die MHRA (Medicines and Healthcare products Regulatory Agancy) zuständig. Die Regelung in Nordirland sind gleich wie folgt. · Directive 93/42/EEC on medical devices (EU MDD) · Directive 90/385/EEC on active implantable medical devices (EU AIMDD) · Directive 98/79/EC on in vi..