Med-Tech Innovation News announced on Apr. 1 that a new white paper is available to help manufacturers of wireless medical devices understand the complex compliance landscape they face when bringing products to market.
As more medical devices incorporate wireless functionality, companies must meet regulatory standards in addition to traditional medical device approvals. The process is complicated by different rules across global markets, making it essential for manufacturers to be fully informed before launching new products.
The white paper, authored by Alex Toohie of Element Materials Technology, details the additional compliance obligations for wireless-enabled medical devices. It covers topics such as CE Marking and RED requirements in the European Union, UKCA Marking after Brexit in the United Kingdom, FCC Certification processes in the United States—including differences between system and modular approval—and ISED Certification in Canada. The guide also addresses RF exposure assessment and Declaration of Conformity obligations.
Toohie said, “Understanding the full process before leaping into a new product launch is absolutely critical to hitting the market on time and without unnecessary costs and complications.”
The publication highlights that using pre-certified radio modules does not relieve host product manufacturers from final compliance responsibility across all markets. It explains key distinctions among regulatory approaches: CE marking’s Declaration of Conformity model, FCC’s certification via testing body approach, and Canada’s ISED process described as “somewhere in the mid-Atlantic” regarding regulatory philosophy.
Element Materials Technology offers specialist testing and certification services through its Connected Technologies & Mobility division. The company holds accreditations as a Notified Body for RED, EMCD, ATEX Directive; an Approved Body for UK Radio; EMC; Explosive Atmospheres Regulations; and as a certification body under IECEE CB Scheme.
