Joint EBE-EFPIA Position on CE Marking
A Topic Group of the joint Personalised Medicine Working Group has been developing a slide deck highlighting the position of the pharmaceutical industry on the need to consider a risk-based approach for biomarker assay development in clinical trials as an alternative to CE marking.
Recently, some National Competent Authorities in Europe have requested for the Marketing Authorisation Holders that conduct clinical trials in the EU to CE mark the diagnostics which are to be used in early clinical trials with a pharmaceutical product. Contrary to this requirement, the in vitro diagnostic (IVD) Directive and IVD Regulation do not request CE marking of a clinical trial assay deployed in early clinical trials. Additionally, some local Ethic Committees in Europe can also request CE marking, sometimes in contradiction with their national authority. These inconsistent CE marking requirements create a complex environment for companies to navigate. Which is why the EBE-EFPIA Personalised Medicine Working Group is proposing to consider a risk-based approach for biomarker assay development in clinical trials as an alternative to CE marking.
The slide deck is available HERE.