A practical checklist for the incoming goods process

This document outlines key considerations for medical device distributors regarding the incoming goods process. Adherence to these steps is fundamental for fulfilling regulatory obligations under the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR).

#Distributor obligations in the supply chain

Distributors play a crucial role in ensuring that medical devices placed on the EU market comply with applicable regulations. Their obligations are detailed in Article 14 MDR and Article 12 IVDR. These articles mandate specific checks before a device is made available to the end-user. The incoming goods process is the primary opportunity to conduct many of these verifications.

#General duties of distributors

Before making a device available on the market, distributors must verify several aspects, as per Article 14(2) MDR and Article 12(2) IVDR:

• The device has been CE marked and the EU declaration of conformity has been drawn up. The distributor must ascertain the device bears the CE marking in accordance with Article 20 MDR or Article 18 IVDR.
• The device is accompanied by the information to be supplied by the manufacturer, in accordance with Article 10(11) MDR or Article 10(10) IVDR. This includes instructions for use and a label.
• For imported devices, the importer has complied with the requirements set out in Article 13(3) MDR or Article 11(3) IVDR. This includes the importer's name, registered trade name or registered trade mark, and registered place of business on the device, its packaging, or in a document accompanying the device.
• Where applicable, a UDI has been assigned by the manufacturer.

Distributors must also ensure that storage and transport conditions are appropriate and in accordance with the manufacturer's instructions. This is specified in Article 14(3) MDR and Article 12(3) IVDR.

#The incoming goods checklist

The following checklist provides a structured approach for distributors when receiving medical devices. This process helps ensure that regulatory requirements are met upon receipt.

| Check Item | MDR Article | IVDR Article | Details and Considerations | | :----------------------------------- | :---------- | :----------- | 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| The device bears the CE marking, and the Declaration of Conformity (DoC) has been drawn up by the manufacturer. The distributor must ascertain this fact, not necessarily verify the conformity itself. | Article 14(2)(a) | Article 12(2)(a) | Check for visible CE mark on the device, its sterile packaging (if applicable), or its outer packaging. Request and review the EU Declaration of Conformity. Compare the device description on the DoC with the received device. Ensure the DoC is current and valid. | | Verify the existence of the CE mark. | Article 14(2)(a) | Article 12(2)(a) | Check the device and its packaging for the CE mark. Ensure it is visible, legible, and indelible. Note any accompanying symbols, for example, the identification number of the Notified Body if applicable. | Ensure the device bears the CE mark according to the relevant Regulation (MDR or IVDR). A visual inspection for legibility and presence is key. For more detail, see: Distributor Obligations: Verifying Medical Devices Under MDR Article 14. | | Verify the EU Declaration of Conformity. | Article 14(2)(a) | Article 12(2)(a) | Confirm the manufacturer has drawn up the EU Declaration of Conformity for the device. Request and retain a copy. Cross-reference the device model, classification, and manufacturer details with the received goods. | Ensure the device is accompanied by the necessary information, including instructions for use. Check that the information is provided in the official language of the Member State where the device is distributed, or in other languages accepted by that Member State. This requirement is generally determined by national law. | | | Verify the information supplied by the manufacturer. | Article 14(2)(b) | Article 12(2)(b) | Check for labels and instructions for use (IFU). Ensure they are compliant with MDR/IVDR Annex I, Section 23 or Annex I, Section 20 respectively. Verify language requirements are met for the distribution Member State(s). Ensure all required manufacturer information (e.g., name, address, UDI, expiration date, lot/batch number) is present and legible. |

#Common mistakes in practice

Distributors frequently encounter challenges in ensuring full compliance. The following common errors can lead to regulatory non-compliance, recalls, and reputational damage:

• Reliance solely on CE marking: While the CE mark indicates conformity, distributors must perform their checks. The Court of Justice of the EU (CJEU) has affirmed that distributors have an independent obligation to verify compliance, not merely to assume it from the CE mark. Refer to CJEU Ruling: Distributors Must Not Rely Solely on the CE Mark for further insights.
• Insufficient language provision for IFU and labelling: Failing to provide Instructions for Use (IFU) and labelling in the official language(s) required by the Member State of distribution is a common oversight. National competent authorities can impose restrictions or require specific translations.
• Inadequate checks on importer details: For imported devices, distributors sometimes neglect to verify that the importer's details (name, registered trade name or trade mark, registered place of business) are present on the device, its packaging, or in accompanying documents, as required by Article 14(2)(c) MDR and Article 12(2)(c) IVDR, referring to Article 13(3) MDR and Article 11(3) IVDR. See also Importer Obligations for Medical Devices Under MDR Article 13.
• Absence of a documented incoming goods procedure: A lack of a formal, documented procedure for incoming goods inspections means checks may be inconsistent or incomplete, making it difficult to demonstrate compliance to competent authorities.
• Failure to verify UDI assignment: Distributors must verify that, where applicable, the manufacturer has assigned a UDI, as per Article 14(2)(d) MDR and Article 12(2)(d) IVDR. This is a critical step for traceability.
• Neglecting EUDAMED registration status verification: While not explicitly an Article 14 or 12 obligation to verify registration, distributors should exercise due diligence by confirming the economic operator they source from is registered, especially for manufacturers, authorised representatives, and importers. Note that EUDAMED functionality has been rolled out in stages. Rules around the EUDAMED modules have changed in stages. The reader should confirm the current status and scope with their national competent authority for applicable requirements, as certain modules (e.g., UDI module, economic operator registration module) are voluntary until a full audit is completed.
• Inadequate record-keeping: Distributors must maintain records of complaints, non-conforming devices, recalls, and field safety corrective actions. Failure to keep thorough records of incoming goods checks and associated documentation (e.g., DoCs, shipping records) hinders traceability and responsiveness.
• Lack of staff training: Staff involved in the incoming goods process may not be adequately trained on regulatory requirements, leading to errors in verification and documentation.
• Ignoring storage and transport conditions: Overlooking the manufacturer's specified storage and transport conditions during receipt can compromise device integrity and efficacy, falling foul of Article 14(3) MDR and Article 12(3) IVDR.

#Corrective actions and continuous improvement

Should any non-conformity be identified during the incoming goods process, the distributor must take immediate action. This includes informing the manufacturer and, where relevant, the importer. As per Article 14(4) MDR and Article 12(4) IVDR, if a device is deemed not to be in conformity with the requirements, the distributor must not make it available on the market. They must also inform the manufacturer, and the importer if applicable, and ensure corrective action is taken. If there is a serious risk, the distributor must also inform the competent authority of the Member State where they are established. This highlights the distributor's role as a critical safeguard within the supply chain.

Establishing a robust quality management system (QMS) that includes detailed procedures for incoming goods, staff training, and a system for managing non-conformities is essential. Regular internal audits and management reviews help ensure the QMS remains effective and compliant.

#EUDAMED and distributor compliance

The EUDAMED database is designed to enhance market surveillance and transparency within the EU medical device sector. While direct distributor obligations for EUDAMED registration are limited, understanding its various modules is beneficial for due diligence. Distributors can leverage EUDAMED to verify certain aspects, such as the registration status of economic operators they deal with. This helps ensure that the devices they handle are from legitimate and compliant sources. This platform can assist in streamlining the management of documentation and checks required for incoming goods, supporting your compliance efforts. For more information, visit our EUDAMED services at eudamedai.com/#funkcije.

This material is for information only and is not legal advice. For binding interpretation consult your national competent authority.