European Dx, Device Trade Groups Consolidate Into MedTech Europe
By Jof Enriquez,
Follow me on Twitter @jofenriq
The European Diagnostic Manufacturers Association (EDMA) and the European Medical Device Manufacturers Association (Eucomed) have formally integrated into a single entity called MedTech Europe effective immediately. It's the culmination of four years of close collaboration between the two associations, which are now dissolved.
“The new MedTech Europe truly crystallises what the medical technology industry stands for: bringing life-changing technologies to patients. MedTech Europe is the only European trade association representing the medical technology industry from diagnosis to cure,” said Rob ten Hoedt, the new chairman of MedTech Europe, in a news release. “We are now in a stronger and unique position to contribute to EU debates on solutions for patients and health systems across the whole continuum of care.”
With the two groups now fully and formally integrated, MedTech Europe says it represents a single voice for a European medtech sector in flux with new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) coming in before early 2017, with full implementation expected by 2020.
“MedTech Europe will provide constructive and essential input to any European debate around healthcare, given that our industry looks at the entire healthcare ecosystem and the full patient pathway. MedTech Europe will continue to provide its diagnostic and device domains with core specific services and expertise. At the same time, we now have even more reasons and resources to become further engaged in forward-thinking healthcare themes, including digitalisation and disruptive technologies such as 3D printing and integrated healthcare,” said Serge Bernasconi, CEO of MedTech Europe.
The association says it retains the ability to help in-vitro diagnostics and medical devices manufacturers of all sizes operating in Europe with their respective concerns. For IVD companies, Medtech Europe will lend assistance during the five-year transitional period, though 2021, leading up to full implementation of new IVDR rules. Medical device manufacturers in Europe, on the other hand, could use some help in implementing a Unique Device Identification (UDI) program, as stipulated in MDR by the European Council and Parliamentary Committees.
Medtech Europe's data shows that 95 percent of Europe’s 25,000 medical technology companies are small and medium-sized enterprises (SMEs). The industry files more patents than any other sector in Europe, provides over 575,000 jobs, and delivers a positive trade balance of €14 billion.