DLA Overseas Policy
The DLA Council are to pursue a policy which requires the European Commission to regulate imported custom made dental appliances so that they meet the following requirements:
1. EU agents for imported custom made dental appliances from outside of the EU must inform their competent authority of their business as an agent for imported goods. (as well as manufacturer of custom made appliances if applicable)
2. Sign a statement that imported custom made dental appliances originating from outside of an EU state meets the Medical Devices Directive requirements.
3. The EU agent for imported custom made dental appliances must be able to prove via an audit that all materials and equipment used to produce the imported custom made dental appliance are all compliant with the Medical Devices Directive.
4. Inspections from the competent authority must include reviewing the paperwork associated with the audit regarding imported custom made dental appliances at every inspection held with that agent.