Where the European Medical Device Regulations (MDR 2017/745 & IVDR 2017/746) have significantly increased the regulatory burden for Legal Manufacturers and Authorised Representatives of medical devices, the burden for Distributors of medical devices has also increased.
Amongst others, medical device Distributors have been assigned specific compliance verification tasks, are required to ensure medical device traceability, and need to execute post-market surveillance tasks on behalf of the Legal Manufacturer. Under certain conditions, the responsibilities of distributors may even mandate the implementation of a quality management system.
Within MedQAIR, we have developed our MDIS solution that can help to automate and document mandatory verification tasks and ensure the receipt of structured information by each of the supplying Legal Manufacturers for each Basic UDI-DI & UDI-DI.
Distributor requirements (article 14)
Article 14 is dedicated to the obligations which apply to the Distributor of medical devices. The article, amongst other obligations, demands that Distributors pro-actively verify whether the devices distributed are CE marked and come with a Declaration of Conformity. This means an active verification of the presence of a CE mark, and potentially verification of the CE certification and the Declaration of Conformity. More often than not, these documents are shared upon the initial product distribution, however, newer versions of products (e.g. new UDI-DIs) might not be proactively shared with the distributor.
In addition thereto, the Distributor should have access to the Instructions for Use, and associated labeling and documentation, including Importer details, as applicable. This information is ideally provided in the language that applies to the countries where the medical device Distributor distributes into.
For medical device Legal Manufacturers, it can be challenging to continuously update all of its Distributors of this information. Similarly, the verification of the UDI, is typically straightforward, however managing an overview of all Basic UDI-DI’s and the UDI-DI’s may not be simple, especially when aiming to ensure traceability over time, e.g. which UDI’s were received over a year ago. Per Article 22, the Distributor must further be capable of demonstrating to which they have supplied a medical device.
The competent authorities of each European Member State may request compliance documentation at any given moment where the Distributor must be able to demonstrate they have fulfilled their obligations.
Where Manufacturing requirements apply to Distributors
Additional Distributor requirements are set out in Article 22 for when the Distributor takes over specific tasks from a Legal Manufacturer, such tasks can include the replacement of the Legal Manufacturer details from the Accompanying Documentation (e.g. the IFU and the Product Label), changing of the intended purposes or modification of a product requiring the compliance documentation to be altered.
Making available and translating the accompanying documentation or packaging is not understood to be a change that leads to the transfer of obligations, yet, it does potentially require the Distributor to disclose these activities have been carried out by them. In this event, the Distributor must implement a quality management system to ensure that they preserve the original conditions of the medical device, and that the replacement of packaging and accompanying documentation is of proper quality.
In the latter situation, the Distributor must report these activities to the Legal Manufacturer and the Competent Authority in the member state where they make the medical devices available. In this application they shall provide a copy of the Quality Management System certificate, issued by a Notified Body.
Where automation supports
Software platforms can support in meeting the obligation requirements. At MedQAIR, we developed MDIS, our Medical Device Information System. The system is intended to support the structured delivery of the relevant documentation by the Legal Manufacturer. The process is simple, the Legal Manufacturer is provided a portal to upload all the required documentation, upon which the relevant aspects per the MDR and or the IVDR are provided to the Distributor for their review, e.g. the Instructions for Use, the Product Label, the Legal Manufacturer SRN, Basic UDI-DI and UDI-DI details, the CE certificate and Declaration of Conformity. If an Importer is involved, the Importer can further upload their labeling details for review to the Distributor. With every change of these details, the Distributor will automatically be prompted if new information is available from the Legal Manufacturer for review.
The verification and approval activities are documented by the Distributor to ensure they comply, and can demonstrate compliance for all received UDI-DI’s. Where a Distributor manages a large number of Legal Manufacturers, they will receive all information in a single portal and ensure a systematic process is in place.
At any moment in time, the Distributor can reject information, which will prompt a review on the end of the Legal Manufacturer to review the rejection, which can be done during the verification process, or thereafter should the Distributor detect a compliance problem with the product.
The system will further allow the direct notification to the Legal Manufacturer of potential product problems in the market, to fulfil the Distributor Post Market Surveillance obligations.
Take-away message
Being a Medical Device Distributor in Europe now means being a compliance stakeholder. The requirements are non-negotiable. Manual processes and fragmented tools are no longer sufficient. A compliance gap can be very risky for every stakeholder involved.
MDIS offers a traceable, auditable, and secure way to stay compliant especially when documentation moves across borders, languages, and systems.
If you’re a Distributor handling medical or IVD devices for the EU market, it’s worth seeing how MDIS can simplify your day-to-day compliance tasks and reduce your liability.
