Implementation a Quality Management System at Importers and Distributors
Importers and distributors often decide to implement a quality system (most often ISO 13485) in order to meet legal requirements and ensure that they only provide medical devices that comply with legal regulations. An effective quality system ensures only that medical devices meeting legal requirements are distributed, inconsistent, defective or unsuitable medical devices can be detected, traceability is maintained, and inconsistencies and changes are controlled.
Obligations of Importers
- It is the responsibility of the importer to ensure that medical devices bear the CE marking, the required information in accordance with the law and, where applicable, that they have been assigned a UDI code.
- The importer should check whether the products are registered in EUDAMED.
- The importer should also inform the legal authorities when he suspects that an appliance has been falsified or that a serious health risk exists.
- The importer obtains information on storage and transport conditions and takes responsibility for them,
- The importer shall indicate on the packaging the name, registered address, trade mark under which they can be contacted.
- Importers shall also be obliged to inform the manufacturers and their authorised representatives of complaints, withdrawals from the market, non-compliances if they suspect that there is a serious risk to health
- Importers shall also cooperate with the competent authorities and provide samples or make the product available.
Obligations of Distributors
Also a distibutor should fulfill the following requrements from the Regulations, which enters into force on 26 May 2021 (medical devices) or 26 May 2022 (in vitro diagnostic medical devices).
- It is the responsibility of the distributor to ensure that medical devices bear the CE marking, the required information in accordance with the law (EU declaration of conformity, labels, instructions for use) in the language in which the device is made available and, where applicable, whether they have been assigned a UDI code.
- The Distributor is responsible for checking whether the name of the Importer is indicated on the packaging,
- The distributor shall obtain information on storage and transport conditions and shall take responsibility for storage and transport under the conditions presented,
- The distributor must inform producers, authorised representatives and importers of complaints, withdrawals from the market, non-compliances if they suspect that there is a serious health risk.
- Distributors shall cooperate with the competent authorities and provide a sample or make a product available.
How can MDR Regulator help?
- We can assist your company in overseeing complaints and other market feedback.
- We can participate in evaluating user information – instructions for use, labels, packaging
- We will assist in the notification or registration of the product
- We will prepare your company for MDR/IVDR
- We will prepare the necessary documentation for notification
- We will provide consultancy services in the field of OBL/OEM cooperation
- We will implement an effective quality system and carry out audits
- We will contribute to efficient marketing and distribution on the EU market