The Irish Competent Authority for medical devices, the “Health Product Regulatory Authority” (HPRA), published a Guide for Distributors of Medical Devices. This document aims to specify the obligations for distributors as outlined in the Regulations (MDR and IVDR), along with supplementary guidance and frameworks that can be used by distributors to meet those obligations. In addition, it sets out the HPRA’s recommendations for good distribution practices. A distributor may have alternative methods for achieving compliance with the regulations and, if justified, these alternatives may be equally acceptable.
Regardless of the fact that the document is issued by the Irish Competent Authority, it is focused on the content of the new EU regulations and thus contains much useful information for distributors throughout the EU/EFTA, and also for manufacturers seeking more clarity on how the responsibilities are divided between themselves and their distributors.
Quality Management System
Even though there is no legal obligation, the guidance clearly recommends distributors to have a quality system in place in order to meet the legislative requirements and to ensure that only medical devices that comply with the legislation are made available for supply. An effective quality system will provide assurance that only medical devices which comply with legislative requirements are distributed, that noncompliant, defective or unsuitable medical devices can be detected, that traceability is maintained and that non-conformances and the introduction of changes are controlled. The document highlights that ISO 13485 is the most commonly used quality framework in the medical device industry but that it is not a requirement that a quality system is officially accredited to any specific standard.
Standard operating procedures (SOPs) should be established to clearly describe how key activities are carried out. At minimum procedures should be in place for:
- Documentation control;
- Approval of suppliers and customers;
- Order processing and deliveries;
- Waste management;
- Change control;
- Management review;
- Quality risk management;
- Management of Field Safety Corrective Actions/recalls;
- Non-conformance management;
- Corrective and preventive actions.
The key components of the Distributor’s Quality System addressed in the document are:
- Quality management;
- Personnel and staff training;
- Documentation and record keeping;
- Medical device receipt, storage and supply;
- Management of returned medical devices;
- Falsified medical devices;
- Medical device recalls;
- Outsourced activities;
The HPRA suggests that each distribution centre appoint a person of appropriate training and experience who will have primary responsibility for ensuring that regulatory responsibilities are met and that the quality system is effective. This person may also serve as the primary contact between the competent authority and the distributor. Other duties that need to be carefully controlled include the segregation, storage and release of returned stock to saleable stock and the handling of product recalls and field safety notices.
It is recommended that a distributor of medical devices has a technical or contractual agreement in place with their supplier. The technical agreement serves as a basis for defining the division of responsibilities between the parties. A technical agreement between a distributor and their supplier should include, but is not limited to:
- relationship of parties and relevant contact details;
- devices covered by the agreement and any specific requirements (e.g. storage conditions);
- transport specifications;
- device traceability requirements;
- responsibilities and procedural aspects in terms of recall/withdrawal procedures, handling returns, complaints, incidents and vigilance (related to distribution and/or device safety and performance);
- review provision for ensuring the agreement maintains relevance to the ongoing operation.
What does this mean to you?
Are you a manufacturer of medical devices working with distributors?
Then you are advised to review your distributors’ ability to meet the new requirements and ensure the necessary technical or contractual agreements are in place. You should also assess the suitability of your quality management system and your supplier management system to address the new obligations of distributors.
Are you a distributor of medical devices in the EU?
If you already have a quality management system in place you will need to assess the gaps and start implementing solutions to close these. If you do not yet have a quality system in place, then you are strongly advised to start on the implementation as soon as possible. All distributors will have to review their current contractual agreements and ensure they have the necessary technical or contractual agreements, annexes or addendums in place to address the new requirements stipulated under the MDR/IVDR so roles and responsibilities between you and your supplier are clearly documented.
Do you need help implementing a Quality System?
Or assessing its readiness?
Would you like to obtain advise on technical and contractual agreements with your suppliers or distributors?
Don’t hesitate to contact us for more information or for support.