MEDIMARK EUROPE

As soon as the European Commission published the proposed new European medical device regulations on September 26, 2012, industry stakeholders raised concerns about some of its provisions. Pan-European industry association Eucomed, which has entered into an alliance with the European Diagnostic Manufacturers Association (EDMA) to form MedTech Europe, and British industry association ABHI have questioned aspects of the regulation, especially the need for the so-called scrutiny procedure. The organizations firmly believe that it will ultimately harm patients and have a negative impact on European governments and industry. MHRA, the UK competent authority, launched in November a consultation to gather views on how the proposed legislative changes will impact UK stakeholders. The MHRA recognizes that changes to the regulation of medical devices on a pan-European level are needed but does not view the scrutiny procedure as the best way to achieve this.