Articles tagged with: Manufacturers' duties

Unrecognized certificates and mandatory authorized representative: the severe consequences of failing to update the Mutual Recognition Agreement.

According to Article 10 of the MDR, manufacturers must compensate for damages from defective products and have sufficient financial coverage.

Clinical investigation is not mandatory if a contract is made with the manufacturer of an equivalent device. For all classes?

Manufacturers, authorized representatives, system and procedure pack producers, and importers must register in Eudamed's Actor registration module.

Quality system, technical file, and notified body. The details of how to obtain CE marking for a medical device.

Advertising for medical devices must be authorized by the Ministry of Health: costs, timelines, rules, and validity of the authorization.