NLMedicalDevices object

S.I. No. 253 of 1994, as amended (transposing Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC, as amended)

Directive 2007/47/EEC (transposed as S.I no. 110 of 2009) introduced relevant changes for implantable and Class III devices and the rules for clinical investigations, amending the principal regulation S.I no. 253 of 1994.

S.I. No. 252/1994, as amended (transposing Medical Devices Directive (MDD) 93/42/EEC, as amended)

S.I no.110 of 2009 (transposing Directive 2007/47/EEC) amending the principal regulation S.I no. 252 of 1994.

S.I. No. 304 of 2001 (transposing In-vitro Diagnostic Medical Devices Directive 98/79/EEC concerning (IVD’s))

The principles of clinical investigation of medical devices, excluding IVDs, are set out in the European standard ISO 14155:2011. This harmonised standard provides a means for getting presumption of conformity to the part of the essential requirements of MDD and AIMD that refers to clinical investigations.

There is no legislation relating to clinical investigations for IVDs. Rather IVDs may require a performance evaluation prior to CE marking and release onto the market. Legislation relating to performance evaluation is contained in the above-referenced IVD Directive.