On October 30, 2018 the European Commission published a new version of the Borderline & Classification Manual. This manual is intended to provide guidance on the status of medical devices and in vitro diagnostics and their risk classifications.
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.
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.
Directive 2007/47/EC enhances the criteria for the conformity assessment of medical devices and strengthens the procedures for such assessment. The Directive aims on the one hand to ensure a high level of protection of human health and safety and on the other hand to ensure that medical devices can circulate freely throughout the Single Market (thereby offering manufacturers economies of scale and users greater choice). Member States were obliged to notify the Commission of measures taken to implement Directive 2007/47/EC by December 21, 2008, but Estonia has so far failed to do so.
Source: European Commission
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.