European Commission Publishes Recommendation on the Audits and Assessments Performed by Notified Bodies in the Field of Medical Devices

Brussels – 24 September 2013 Today, the European Commission published a recommendation on the audits and assessments performed by notified bodies in the field of medical devices. The Recommendation provides general guidelines for product assessments, quality system assessments and unannounced audits. The guidelines do not include new rights or obligations, but aim to ensure that notified bodies carry out a proper verification of the fulfilment of the legal requirements by the manufacturer.

European Commission Sues Estonia Over Medical Device Directive

Brussels, 24 June 2010. The European Commission has decided to refer Estonia to the EU’s Court of Justice for not implementing the revised Medical Devices Directive (2007/47/EC) within the deadline (December 21, 2008). A referral of the case has been decided today as Estonia failed to notify transposition measures as required by this Directive.

European databank for medical devices to boost control

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.