Today, the European Commission published an update of the list of European harmonized standards for the Medical Devices Directive (93/42/EC), the Active Implantable Medical Devices Directive (90/385/EEC), as well as the In Vitro Diagnostics Directive (98/79/EC).
The European Commission has referred Greece back to the EU’s Court of Justice because of its failure to apply EU rules on public procurement as regards contracts for supplies of medical equipment to hospitals. In the Commission’s view, Greece continues to infringe EU law and has not complied with a Court judgment of 19th March 2009 (C-489/06). The Court ruled that Greece had failed to fulfil its obligations under EU rules on common safety standards for products as well as on public procurement by rejecting offers from suppliers of medical equipment bearing the CE marking. As Greece has still not complied with the Court judgment, the Commission has now decided to refer the case back to the Court again and will ask the Court to impose financial penalties on Greece of 7173,06 euro per day from the date of the original Court ruling until Greece finally complies with EU rules or until the second Court ruling whichever comes first, as well as 43724,8 euro per day from the date of the second Court ruling until Greece finally complies with EU rules.
A European Commission decision adopted on April 19 will oblige all EU countries to use, as of May 2011, a European databank for medical devices (Eudamed). Medical devices range from life-supporting devices such as pacemakers through hip implants or X-ray machines, down to products used daily such as syringes or blood tests. Even though these devices are traded on the European single market, data which are key to their safety – such as conformity certificates, data on clinical investigations – are for the time being collected only at the national level. The Eudamed databank is a secure IT tool which will ensure rapid access to such data by market surveillance authorities. The databank will also streamline the rules for manufacturers placing in vitro diagnostic (IVD) devices on the market.