The European medical device community has one year to go until the Medical Device Regulation (MDR) goes into effect, but little progress has been made toward implementation of the regulatory scheme, according to the European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry (COCIR).
COCIR members have "invested considerable resources" to prepare themselves for MDR but are still lacking guidance from European regulatory authorities. COCIR discussed the medical device community's current state of readiness in a new report available on the group's website.
COCIR said it is counting on the European Commission and member states to "take a pragmatic approach to ensure that healthcare delivery will not face any negative consequences from the implementation of the new regulation."
