Significant change is coming to the regulatory approval process for IVD products marketed in Europe. How will it affect your company? Maureen Mende, senior director at IVD consultancy Myraqa, has some thoughts on that, and she will share them during the forthcoming conference on the Evolution of Advanced IVDs in San Diego, CA.
In Mende's estimation, the revision of the IVD Directive won't have a huge impact on companies with a global business approach. Small companies and startups eyeing Europe as a launch pad for their IVD tests, however, may feel the pinch.
"If adopted, the proposed changes would increase the regulatory burden for IVDs in the European Union," says Mende. In particular, the EU regulatory framework would align more closely with the United States. Companies that develop IVDs for global commercialization by and large would be able take this in stride. Small companies and startups planning to launch their IVD tests in the European Union to take advantage of the [current] lower regulatory threshold would feel the greatest impact.
"The regulatory strategy of launching as an in-house test or launching in the EU first to generate early revenue probably will be less attractive to companies than it has been in the past," she notes. The proposed changes to IVD classification and to conformity assessment requirements will place the greatest burden on companies with a large number of legacy products already on the EU market, as "costs associated with bringing these products into compliance might not be worth the additional investment."
During her presentation, Mende also will clarify clinical evidence requirements and address proposed changes in the classification of companion diagnostics, the status of exemptions for in-house tests and proposed conditional CE marking, among other topics.
Examining Current EU Regulations and Upcoming Legislation Impacting IVD Approvals Overseas is one of more than a dozen papers that will be presented at the Evolution of Advanced IVDs conference. The meeting will provide unique insights on IVD business, technology and regulatory strategies from a host of experts in their fields. Produced by IVD Technology, the conference will be held at the San Diego Convention Center on Sept. 19 and 20. Go to the IVDTconference website for a complete schedule and registration information.