MDR Implementation Concerns Expressed at EPSCO Council Meeting
Significant attention was given to MDR and IVDR implementation at the EU's Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) last week, with 20 member states expressing concern over the readiness of the regulations.
This important step highlights that the issue has been elevated politically, with a message to the European Commission that action will need to be taken to alleviate the situation.
Elsewhere, a new Commission Factsheet has acknowledged there may be supply chain problems during the transition, stating the potential for some devices to "become temporarily unavailable."
We continue to relay these messages to the MHRA and are regularly communicating to Ministers the impact that bottlenecks could have on the supply of products to patients. The issues demonstrate why the regulatory landscape remains a critical priority for ABHI and we will continue to update you on the latest developments.
