Incoming Goods Inspection for Medical Devices: A Repeatable Verification Process

Distributors and importers of medical devices within the European Union bear significant responsibilities under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). These responsibilities include the establishment of a robust system for the verification of incoming goods. This ensures that only compliant devices are placed on the market.

#Obligations for Distributors and Importers

Both distributors and importers have distinct, yet interconnected, roles in the supply chain and are subject to specific requirements. Article 13 MDR and Article 11 IVDR define the obligations for importers, while Article 14 MDR and Article 12 IVDR detail those for distributors.

#Importer Obligations

Importers must ensure that devices they place on the EU market comply with the MDR or IVDR. Before placing a device on the market, an importer must verify several aspects as per Article 13(2) MDR and Article 11(2) IVDR. This includes confirming:

• The device has been CE marked.
• A European Union declaration of conformity has been drawn up for the device.
• A UDI has been assigned by the manufacturer, where applicable.
• The manufacturer is identified and has fulfilled its obligations regarding labelling.
• The device is accompanied by the information required by Article 7 MDR or Article 7 IVDR (labelling and instructions for use).
• The manufacturer has assigned a single authorised representative (where applicable).

Importers must also verify that the manufacturer has carried out the appropriate conformity assessment procedure. If an importer considers or has reason to believe that a device is not in conformity with the MDR or IVDR, they must not place the device on the market (Article 13(4) MDR, Article 11(4) IVDR).

#Distributor Obligations

Distributors must act with due care regarding the requirements of the MDR or IVDR when making a device available on the market (Article 14(1) MDR, Article 12(1) IVDR). Before making a device available, a distributor must verify that:

• The device has been CE marked.
• The EU declaration of conformity for the device has been drawn up.
• The device is accompanied by the information required by Article 7 MDR or Article 7 IVDR (labelling and instructions for use).
• An importer, where applicable, has complied with the requirements set out in Article 13(3) MDR or Article 11(3) IVDR (identification of importer).

If a distributor considers or has reason to believe that a device is not in conformity with the MDR or IVDR, they must not make the device available on the market (Article 14(2) MDR, Article 12(2) IVDR). The distributor must inform the manufacturer, and the importer and, where appropriate, the national competent authority.

#Establishing a Repeatable Verification Process

A repeatable incoming goods inspection process is an essential component of a distributor's or importer's quality management system (QMS). This process ensures systematic compliance with the verification obligations. The QMS should include documented procedures for the receipt, inspection, and release of medical devices.

#Key Elements of the Process

1. Documentation Review: Verification of accompanying documents such as the CE declaration of conformity, delivery notes, and any relevant certificates. This confirms that the device is legally placed on the market.
2. Labelling and Instructions for Use (IFU) Check: Confirmation that the device bears the CE marking visibly and legibly. All required information, including manufacturer details, batch or serial numbers, and expiry dates, must be present and legible on the label and IFU. The IFU must be in a language determined by the Member State where the device is made available (Article 7(2) MDR, Article 7(2) IVDR).
3. Unique Device Identification (UDI) Verification: Where applicable, the UDI carrier must be present on the device label or its packaging. Distributors and importers should check its legibility.
4. Packaging Integrity: Inspection of packaging for any signs of damage, tampering, or compromise that could affect the sterility or integrity of the device.
5. Quantity and Product Matching: Reconciliation of the received quantity with the order and delivery documentation. Verification that the product received matches the product ordered.
6. Storage Conditions: Confirmation that devices requiring specific storage conditions (e.g., temperature, humidity) have been transported and received under these conditions.

An example of a structured inspection checklist element:

#Documenting the Process

All inspections, non-conformities, and corrective actions must be documented. These records form part of the QMS and serve as evidence of compliance during audits or inspections by competent authorities. Sampling methods for these inspections should be defined and documented. For further guidance on defining sampling methods, refer to resources such as How to define and document a sampling method for medical devices under MDR.

#Non-Conformities and Corrective Actions

Upon detection of a non-conformity, the device must be quarantined. The importer or distributor must then inform the manufacturer, and the importer if applicable, and the national competent authority if a serious risk is identified (Article 14(2) MDR, Article 12(2) IVDR). Appropriate corrective and preventive actions (CAPA) must be initiated and documented to prevent recurrence.

#Common mistakes in practice

• Lack of documented procedures: Operating without clearly defined and approved incoming goods inspection procedures.
• Incomplete checks: Focusing only on superficial aspects, such as packaging, and neglecting critical regulatory checks like the presence of a valid EU Declaration of Conformity or correct labelling information.
• Insufficient training: Personnel conducting inspections are not adequately trained on the specific requirements of the MDR/IVDR or the established internal procedures.
• Poor record-keeping: Failure to document inspection results, non-conformities, or corrective actions thoroughly and systematically.
• Inadequate sampling plan: Not having a scientifically sound or documented sampling method for medical devices under MDR for larger batches, leading to insufficient verification.
• Ignoring language requirements: Not verifying that instructions for use and labelling are in the official language(s) required by the Member State of distribution (Article 7(2) MDR, Article 7(2) IVDR).
• Assuming manufacturer compliance: Relying solely on the manufacturer's assurances without conducting the mandated verifications.
• Failure to report: Not informing the manufacturer, importer, or competent authorities when non-conformities or serious risks are identified.

Regular reviews and updates of the incoming goods inspection process are vital to maintain compliance, especially as regulatory requirements or product specifications evolve. Leveraging digital tools can streamline these processes; for instance, platforms like EUDAMED AI can assist in managing compliance data and documentation, helping ensure that regulatory checks are systematically performed.

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