On November 15, 2010 the EU Commission issued a Formal Objection to the harmonization of eleven standards to the Medical Device Directives.
The Medical Device Industry regrets this action by the EU Commission and fails to understand why the EU Commission wishes to use this mechanism, in view of the consequences of it for the practical use of the standards challenged. Not harmonizing standards that have successfully followed the existing process or,
worse, possibly ‘de-harmonize’ standards already harmonized under one of the Medical Device Directives, has both a technical and a political dimension with possible negative impact on patient safety.
Such consequences appear not warranted by the evidence provided in 53/2010.