EU regulators' proposals underline need for work on classification and borderline products issues

In an effort to control costs and streamline decision-making around the regulation of borderline and drug-device combination products in the EU, medical device regulators from member states under the aegis of the Central Management Committee have put forward two proposals for increased co-operation between competent authorities to ensure better transparency and sharing of expertise in these areas¹. The proposals also aim to achieve harmonised decision-making which is currently lacking in the system.