The European Coordination Committee of the Radiological Electromedical and Healthcare IT Industry (COCIR) said it is skeptical of a proposal calling for an alternative marketing authorization procedure for medical devices.
Reports have been recently produced by the European Parliament's Environment; Internal Market and Consumer Protection; and Employment, Social Affairs, and Inclusion Committees on the European Commission's proposal for a medical devices regulation. While COCIR agrees the current regulatory framework for medical devices needs to be modernized and strengthened, the organization is urging caution on a proposal by Rapporteur Dagmar Roth-Behrendt for the creation of an alternative marketing process for Class III and other "innovative" devices.
COCIR said it's skeptical of the possible claimed benefits of such a system and the European Commission's current draft resolution strikes a better balance for patient safety and timely access to innovative technologies in Europe. An alternative marketing authorization procedure for these medial devices would be expected to add additional complexity, delays, and costs for the European medical devices sector, COCIR said.
