Can the EU Industry Balance Regulatory Harmonisation Without Losing the "3"

Leading US and European industry associations have publicly applauded the announcement to launch US-EU trade negotiations. This is according to an announcement by MedTech Europe, the body representing Europe’s manufacturers of medical devices and diagnostic instruments. The announcement was made immediately after the G8 summit of leading heads of government in Northern Ireland in June 2013. The US associations include AdvaMed (medical device manufacturers) and MITA (US medical imaging technology alliance). The European ones are Eucomed (medical devices) and EDMA (diagnostics) via their new umbrella association MedTech Europe we well as COCIR (radiological, electro-medical and other IT and communications technologies).

A key driver behind the industry’s interest in these negotiations is to encourage regulatory alignment between the USA and the EU. Harmonisation between the two markets would make it easier for the associations’ members to do business on both sides of the Atlantic.

While harmonisation with US regulations would make exporting companies’ operations simpler, there are components of the US systems which are more stringent than those currently in force in the EU. But Eucomed is lobbying against the scrutiny procedure, a process more akin to the US system, as part of its Don’t Lose the 3 Campaign. Medical Plastics News asked Eucomed to explain the apparent dichotomy between, on the one hand, supporting regulatory harmonisation with the USA—a system known for its conservatism and increasingly longer waiting periods for approvals—and, on the other, arguing that scrutiny procedure is too stringent for no benefit and is likely to slow down approval time and stifle innovation.

Eucomed’s response was as follows. “While it is true that Eucomed does not believe that Europe should move towards a centralised pre-market authorisation system for the approval of medical devices like the one used by the FDA in the USA, we believe that regulatory convergence in several other areas would be of mutual benefit to patients, healthcare systems, industry and medical device innovation. Eucomed is working with transatlantic partners to urge US and EU authorities to work toward the inclusion of single audits of medical technology manufacturer quality management systems, a single harmonised standard for marketing application format and unique device identification (requirements for marking/labelling and the unique device identifier (UDI) database) in the final agreement. Eucomed believes concerted efforts on these fronts will lead to expanded US-EU trade and investment and facilitate medical device innovation on both sides of the Atlantic.

Representatives from the associations met with senior US and EU government officials in April 2013 to present the arguments for regulatory convergence, focusing on ISO13485,  a single audit process, harmonised product registration and a common traceability process.