In February 2007, the European Commission adopted the Regulation and Accreditation Proposal (RAMS) package which forms part of its movement of goods package.
The main objective of the proposal is to enhance EU competitiveness by strengthening the systems that support harmonisation legislation both before products (which includes medical devices) are placed on the market and afterwards, in order to create a level playing field.
The RAMS package consists of two distinct parts. First, a regulation that is binding on all Member States from 1 January 2010 and second, a Commission Decision that, while not binding, sets the preferred ‘route of travel’. The intention is that the Decision’s content be taken into account in any further legislative developments.
We have prepared a document that you can access at the bottom of this page which gives a detailed explanation of the regulations and how the MHRA intends to fulfil the obligations which are placed on it, as well as links to the European Commission and the Department for Business, Innovation and Skills (BIS) who also have information on the regulations.
