Medical Device Legislation in the European Union – Revision of Current Framework including Unique Device Identification (UDI) Regulation is Coming Soon?
If you place a medical device on the market your company must comply with the relevant legislation and corresponding processes. In order to gain access in Europe your company must follow the current European Commission framework which is composed of three directives: Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) -1990 Council Directive 93/42/EEC on Medical Devices (MDD) -1993 Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD) -1998 Latest modification of these three main directives have been by the directive 2007/47/EC in 2007. The European Commission is in the process of drafting new regulations to govern the…
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KVALITO set-up new SMARThub to be closer to and support our client in Western Europe. KVALITO Ireland supports KVALITObase and regional management in delivering KVALITO services to our clients. Would you like an update everytime we write a blog post? Subscribe here! * indicates required Full Name * Email Address * Company Work Position
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