Medtech regulatory reform in the EU: Look to existing guidance documents and forget pre-market scrutiny

摘要

Working together over many years under the Global Harmonization Task Force, regulators and industry representatives from around the world have generated a considerable amount of valuable guidance in the area of medtech regulation.The European Commission states that this guidance - and European guidance documents (known as Meddevs) - have been taken into account in the drafting of its recently released proposals for a Medical Device Regulation. This is to be welcomed.The opening text of the proposed regulation states:To the extent possible, guidance developed for medical devices at international level, in particular in the context of the Global Harmonization Task Force (GHTF) and its follow-up initiative the International Medical Device Regulators Forum (IMDRF), should be taken into account to promote the global convergence of regulations which contributes to a high level of safety protection worldwide....