Module 15 Presentations

4/15/2024

The UK

© NAMSA 2021

33

Brexit and the Introduction of UKCA

UKCA

• The UK left the EU on 31January 2020 • Transition period, during which EU law (MDR/MDD/AIMD or IVDR/IVDD) continued to be recognized in the UK • This transition period ended 31 December 2020 • 1 January 2021: Medical devices and In Vitro Diagnostics (IVDs) subject to UK law • UK Conformity Assessment (UKCA ) mark was introduced • Devices on the UK market became legislated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) ( UK MDR 2002) • UK MDR 2002 was based on the text of the EU Directives: • Directive 90/385/EECon active implantable medical devices (EU AIMDD) • Directive 93/42/EECon medical devices (EU MDD) • Directive 98/79/ECon in vitro diagnostic medical devices (EU IVDD)

UK C onformity A ssessed

34

© NAMSA 2021

34