With the new MDR’s coming closer it becomes urgent for companies present in the EU market to sort all matter of distribution issues.
The EU distinguishes several levels of economic actors: the Manufacturer, the Authorized Representative, the Importer and the Distributor, and each of these actors is now referred to in the Regulations.
In this second article we will specifically review the role of the Distributor. While the role of the Importer differs in some aspects, it is otherwise very similar.
The Distributor under the MDR, IVDR
The Importer is any natural or legal person established within the EU that first makes a device available on the Union Market, other than an investigational device.
The Distributor is any natural or legal person in the supply chain, other than the Manufacturer or the Importer, who makes a device available on the market up until the stage at which the device has been made available to the final end-user as being ready for use
Both Importer and Distributor have responsibilities up and down the supply chain. For instance, both are expected to stop the making available of devices when they learn that the devices are no longer in compliance, and both are independently responsible for verifying that the devices meet the requirements set forth in the MDR, IVDR.
Importers and Distributors are also required to check the CE mark, make sure the device is properly labeled and where needed, carry the proper UDI. They are responsible for tracking the UDI’s: where the device came from and where it went.
Furthermore, both Importer and Distributor are required to maintain a register of complaints and recalls.
The specific requirements can be found in MDR or IVDR article 13 (Importers) and 14 (Distributors)
To comply with these requirements, it is recommended that Distributors implement a QMS, and the Member State’s Competent Authority can audit the Distributor for compliance.
Competent Authority (CA) Guidelines for Distributors.
While each of the CA’s may have their own interpretation of the Regulations and how Distributors can comply, the general guidelines should pretty much be the same between the different CA’s.
The Irish Competent Authority HPRA published a document that extensively describes their expectations. It makes a very useful Guide for Distributors of Medical Devices -and manufacturers-, who want to understand the impact of the MDR’s on the supply chain.
In the guide, the Irish Competent Authority (CA) stresses that it expects the Distributor to have in place a Quality Management System (QMS). Even though this Competent Authority mentions ISO 13485, they do not proscribe any specific QMS.
The Quality Management System in place at the Distributor is expected to not only address issues such as Corrective and Preventative Actions (CAPA) and complaints, but also:
Personnel and training
The CA expects that Personnel involved in the distribution of Medical Devices has the appropriate training and experience to perform their role, and that the roles are sufficiently staffed to be responsibly carried out.
Documentation and record keeping
Distributors are expected to keep adequate records to show where a device came from and where it went. These records are meant to support recall of a specific device or the entire lot if and when required.
Medical Device Receipt, Storage and Supply
Distributors are expected to develop a procedure to receive a new device into the Distributor’s system. This procedure should be sufficiently strong to prevent falsified products from entering the system. The procedure should also address such issues as storage and transport conditions.
Management of returned Medical Devices
Distributors are expected to be extremely vigilant in case of returned devices. Only when a Distributor is fully confident that a safety and performance of a returned device has not been affected should the Distributor be allowed to enter the device back into saleable stock.
Falsified Medical Devices
Distributors should develop procedures and show vigilance in their efforts to identify falsified devices and prevent them from entering their system.
Medical Device Recalls
The Distributor must have a recall procedure in place to facilitate an immediate recall if necessary. The Irish CA, for instance, wants the Distributor to implement a mock recall at least once a year to test the effectiveness of the recall procedure.
The Distributor is allowed to outsource activities related to the distribution of Medical Devices. In such a situation the distributor must have agreements in place that clearly show the division of responsibilities of each of the parties involved. No matter the agreement, the Distributor retains the ultimate responsibility.
Medical Devices need to be transported in accordance with the labeled requirements. Any subcontracted transportation arrangements must be documented in a service level agreement.
The Distributor must perform self-audits to test the effectiveness and compliance of its Quality Management System. A log of outcomes must be kept, and corrective actions must be documented.
In Part 1 of this series we discussed the expanded role of the Authorized Representative.