SMART quality & compliance
eMDR (Electronic Medical Device Reporting)
Medical devices are controlled and regulated by the Food, Drug, and Cosmetic Act (Code of Federal Regulations 21, 2010), which demands registration of any medical devices, which meets the definition of a medical device before starting selling it. It states that manufacturers are responsible for ensuring that e.g.: products are safe and labeled according to FDA’s labeling regulations, before any selling permission is given. Medical devices sector is a highly delimited part of economy; its regulatory procedures ensure patient safety, security and product quality. In fact it has significant implications for the overall industry’s performance. Each year, the number of…
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SMART quality & compliance
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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