Competent authorities
Each EU member state must designate a competent authority that is responsible for implementation of the applicable regulations, such as the IVDR. Competent authorities have many roles and responsibilities within the context of the national medical device regulations, such as the MPDG in Germany. Roles are for example:
- Approval of submitted study proposals
- Provision of advice for manufacturers (e.g, Scientific Advice Meetings)
- Evaluation of severe adverse event notifications
- Implement measures for the protection regarding risks from medical devices
- Maintenance of a submission database (e.g. DMIDS in Germany)
- Recall of medical products
- Provide adequate information for the public
- Clarification of a product classification, if this cannot be agreed between the manufacturer and the Notified Body
In Germany, the BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) as well as the PEI (Paul-Ehrlich-Institut) as known as Competent Authorities.
