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Distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;
According to MDR (Article 14), the Company that distribute the medical devices to the final user in the EU needs to verify that:
- The device is CE marked, and its declaration of conformity has been drawn up
- The device is accompanied with compliant IFU and labelling
- UDI is assigned
- Importer name and address are adequately identified on the device
BioReg can help you understand distributor(s) obligations and how to define these responsibilities in the quality agreement properly.
Further, the distributor should:
- Ensure that product storage or transport conditions comply with the requirements set by the manufacturer
- Cooperate with the manufacturer, Authorized Representative, importer and Competent Authority, as needed, to ensure corrective action is made in case non-conformity is identified
- Not make the device available on the market (should not start or continue distributing the device) until conformity to MDR is established
- The distributor has additional obligations related to post-marketing activities and traceability of the product.
Although the Regulation does not require distributors to hold ISO 13485 or any other quality standard, it is suggested that distributors have a quality system in place as a best practice.
The purpose of such a quality system is to ensure that only medical devices which comply with MDR requirements are distributed (see HPRA Guide for Distributors of Medical Devices (IA-G0004-2, 2020).
If your distributor is not officially certified, you should check that their quality system includes at least the following internal should Standard Operating Procedures (SOPs):
- Documentation & record control
- Traceability of products
- Order processing and deliveries
- Pest control
- Storage & Transport
- Internal Audits
- Change control
- Quality risk management
- Management of Field Safety Corrective Actions
- Recalls and withdrawals
- Management of returned medical devices & Disposal
- Corrective and Preventive actions
- Computer system & other critical processes validation
- Communication with Economic Operators and Competent Authority
- Outsourced activities management
For more information, please contact the BioReg team.
In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.