Public budgets top of mind in Parliament when considering Europe's propsed medical device regulation
Neil Armstrong of Meddiquest points out that the proposed amendment to the MDD is for a overarching regulation, rather than a directive, for member states. If it is approved, the European industry will benefit from a standardised and consistent set of rules across all member states.
He wisely explains that the MDD is still a proposal and it has to be approved by the member states of the European Parliament, some of whom may object to some of the costs involved. Costs which may be challenged in particular are those involved in setting up the Unique Device Identifier (UDI) database. Neil's closing analogy is that if the EC wants to cut its clothes according to the cloth available, then there may be a number of challenges ahead in passing this regulation in its current form.