Why must inform/notify/register with the Competent Authority?
Legal basis: All the three EU directives concerning medical devices, i.e., the Medical Devices Directive (MDD 93/42/EEC amended by 2007/47/EC)*, In Vitro Diagnostic Device Directive (IVDD 98/79/EC)**, and Active Implantable Medical Devices Directive (AIMDD 90/385/EC) *** require manufacturers or, their authorised representatives or others placing medical device(s) on the EEA market, to provide certain information to the Competent Authorities in the EEA Member State where they have a registered place of business. * Article 14 of Directive MDD 93/42/EEC amended by 2007/47/EC; ** Article 10 of Directive IVDD 98/79/EC; *** Article 10 of Directive AIMDD 90/385/EC. These requirements have been transposed into national laws of the EEA Member States. In UK, the national law is Medical Device Regulations 2002: Regulations 19 and 44 registration of persons placing general medical devices and/or in vitro diagnostic medical devices on the market. After the receipt of the notification/registration,
