The European Commission’s public consultation on proposed revisions to the In Vitro Diagnostics Directive (98/79/EC) makes reference to “conditional CE marking,” reports Clinica (subscription required). And that has generated some buzz in the couloirs at Eucomed and within the larger medtech community. Section 5.1 of the consultation states the following:
For unmet medical needs of patients, for example in the case of rare diseases or in emergency situations such as a pandemic, it might be useful to introduce a mechanism which can allow a rapid market access of certain IVDs subject to certain conditions. Currently, Article 9(12) of Directive 98/79/EC makes provision that Member States can accept IVDs in their respective territories without proper conformity assessment procedure if this is justified in the interest of public health protection. Instead of such national solutions, a “conditional CE marking” might be allowed for a limited period of time (e.g. one year renewable) and subject to specific obligations imposed on the manufacturer with a view to confirm the safety and performances of the tests.
Although this would only apply to IVD products, it has captured the imagination of John Brennan, Director of Technical and Regulatory Affairs at Eucomed, who told Clinica that this “could be an interesting vehicle for innovation in Europe.”Norbert Sparrow