Reform efforts of the European lawmakers are casting its shadows: The draft for a new regulation on medical devices – which was released at the end of September by the European Commission – was not entirely welcomed by manufacturers and producers. However, the legal nature of the regulations is welcomed – as a regulation these standards will apply to all member states in the future. And the exasperating mismatches due to different national conversions will be a thing of the past.
From a practical point of view the following approach is heading in the direct direction as well: on the European scale a board is supposed to be established which supports member states when classifying products from the gray area between medicinal products and medical device legislation (so called borderline products like bone implants with an anti-inflammatory medicinal product constituent). With regards to questions of demarcations applicants in the past were left to the national authorities‘ perception of the applicable law. If the board would be established like planned, legal certainty would be created and the European thought of harminization would be promoted.