“We don’t want to introduce radical change,” Jacqueline Minor, Director Consumer Affairs of DG Sanco, told Eucomed Forum attendees yesterday afternoon, in an attempt to allay industry concerns. “Our task is to deliver a recast of the Medical Devices Directive that lives up to the ideals of a safe, smart and sustainable system. But there are weaknesses,” she added, citing variations in implementation and ways of addressing assessments. She also pointed to the need for a more coordinated mechanism to address device-related concerns. “We will bring forward a proposal in early 2012,” she promised.
Eucomed strongly believes that the current notified body based system requires improvements in implementation but not a major overhaul, noted the pan-European trade association in a press release issued yesterday afternoon. The regime of certification with CE marking has given patients and consumers in Europe the fastest access to the most innovative devices with the highest quality and safety standards in the world. To better align safety levels and administrative procedures throughout the European Union, member states should be presented with effective tools to improve coordination of their management of the system, noted Eucomed.
The Eucomed Forum continues today, 14 October 2010, at the Crowne Plaza in Brussels.Norbert Sparrow