Council Directive 98/79/EC

Medical Device Legislation in the European Union – Revision of Current Framework including Unique Device Identification (UDI) Regulation is Coming Soon?

by Lara Bartlett | Oct 29, 2015 | SMART Life Science

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:...