Mar 23, 2011

European medical device industry trade group Eucomed has issued four major recommendations to the European Commission regarding easing regulatory requirements for small and medium-sized enterprises (SMEs) in order to foster innovation. Eucomed has published a position paper, European Health and SMEs: Big Challenges, Small & Medium Sized Solutions, following a survey the group conducted over the course of 2010 of 12 European national medical technology industry associations to pinpoint major regulatory barriers to SMEs.

Based on those survey findings, Eucomed has made four broad recommendations to EU regulators that the group argues will reduce unnecessary compliance requirements for smaller-tier medical device manufacturers.

First, Eucomed suggests a coordinated and transparent market surveillance program able to target specific product groups for both domestic and imported devices.

Second, the trade group argues for faster commercialization of "novel technologies" in order to expedite patient access to cutting-edge treatment and products.

Third, easier application processes for research and design funding programs should be established so that SMEs can more effectively access those funds.

Fourth, Eucomed urges broader information sharing among member state competent authorities pertaining to market access models and distribution channels to increase the overall size of the European medical device market.

On a related note, the trade association has suggested more transparent and predictable purchasing processes across the EU to clear up persistent questions about reimbursement and procurement; Eucomed also recommends scaled down Health Technology Assessment procedures be made available to SMEs with limited resources. (Eucomed plans to issue a separate document more fully discussing these two suggestions at a later, unspecified date.) Furthermore, Eucomed has requested that the European Commission conduct a comprehensive survey of SMEs in the medical technology industry in order to more fully identify these firms’ operational needs and characteristics.


  • Stewart Eisenhart