Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "EU Health IT Sector on Alert After Parliament Adds 'Prediction' to Medical Device Definition."
Following is an excerpt:
Device reform legislation approved by the European Parliament in October tweaks the definition of a medical device in a manner that could have big implications for the health information technology sector.
October's European Union Parliamentary bill to reform the continent's method for regulating medical devices may contain an unwelcome surprise for developers in the health information technology sector: a large expansion in regulation.
The bill gathered controversy among device companies based on its proposals to centralize authority for pre-market approvals for certain high-risk devices, as well as allowing more aggressive reprocessing of single-use devices. ...
Bradley Merrill Thompson, a lawyer representing the mHealth Regulatory Coalition, says that he hasn't heard as much concern about the definition change from the American companies he represents. "I don't think it has really percolated to them yet," he noted. "But I really think it's something companies should be paying attention to."
