CJEU Ruling: Distributors Must Not Rely Solely on the CE Mark

A recent ruling by the Court of Justice of the European Union (CJEU) has significant implications for distributors of medical devices within the EU. The judgement clarifies the scope of verification obligations, particularly regarding the CE marking. Distributors must understand that their responsibilities extend beyond merely observing a CE mark.

#The CJEU Ruling and its Context

The Court of Justice of the European Union, in its judgement dated 16 March 2023 (Case C-320/21), provided crucial interpretation on the duties of medical device distributors. While the specific case pertained to Directive 93/42/EEC (MDD), the principles established are directly relevant to Regulation (EU) 2017/745 (MDR) due to the analogous nature of distributor obligations. The Court ruled that distributors are not permitted to rely exclusively on the CE marking affixed to a device. Instead, they must exercise due care to ensure devices comply with the applicable regulatory requirements.

This ruling underscores that the CE mark is a declaration by the manufacturer, not an absolute guarantee that absolves other economic operators from their own defined responsibilities. The distributor's role is critical in the supply chain to ensure product safety and compliance. The judgement clarifies that national competent authorities retain the power to impose sanctions on distributors who fail to meet their verification obligations, even if a CE mark is present.

#Distributor Obligations Under the MDR

Regulation (EU) 2017/745 (MDR) delineates specific obligations for distributors in Article 14. These duties are designed to ensure that devices placed on the market are compliant and safe for users.

#Before Placing a Device on the Market

Article 14(2) MDR requires distributors to verify the following points before making a device available on the market:

• CE marking: The device bears the CE marking in accordance with Article 20 MDR.
• EU Declaration of Conformity: An EU declaration of conformity has been drawn up by the manufacturer.
• Labelling and Instructions for Use (IFU): The device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11) MDR. This information must be in an official Union language determined by the Member State where the device is made available, unless otherwise provided by that Member State.
• Manufacturer and Importer Information: The manufacturer has assigned a UDI, where applicable. The manufacturer and, where applicable, the importer, have complied with the requirements of Article 10(6) and Article 13(3) MDR respectively. This includes the availability of their name, registered trade name or registered trade mark, and the address of their registered place of business on the device or its packaging or in a document accompanying the device.

#Detecting Non-Conformity

Beyond these initial checks, Article 14(3) MDR mandates that if a distributor considers or has reason to believe that a device is not in conformity with the MDR, they must not make the device available on the market. They must inform the manufacturer and, where applicable, the importer. If there is a serious risk, they must also inform the competent authority of the Member State where they are established.

Furthermore, Article 14(4) MDR states that distributors who have reason to believe a device they have made available on the market is not in conformity with the MDR must immediately inform the manufacturer and, where applicable, the importer. They must also cooperate with the manufacturer, importer, and competent authorities to ensure the necessary corrective action is taken.

#Traceability and Documentation

Distributors must also ensure they can identify the economic operator who supplied them with the device and the economic operator to whom they supplied the device (Article 14(5) MDR). This traceability requirement is crucial for market surveillance activities.

#Implications for Due Diligence

The CJEU ruling reinforces that the checks specified in Article 14(2) MDR are not merely formal. Distributors must exercise a degree of professional diligence to detect 'obvious signs of non-compliance'. This might include:

• Missing or illegible CE marks.
• Absence of an EU Declaration of Conformity or one that is incomplete or does not refer to the correct regulation.
• Language of labelling or IFU not compliant with national requirements.
• Lack of manufacturer or importer details on the device or packaging.
• Damaged packaging or device suggesting transport issues or tampering.
• Any other readily apparent inconsistency with the requirements of the MDR.

It is important to note that distributors are generally not expected to conduct exhaustive technical tests or re-evaluate the manufacturer's conformity assessment. Their responsibility lies in acting as a vigilant gatekeeper for the devices entering the supply chain, identifying issues that are reasonably discoverable through their defined obligations.

#Distinction from Importer Obligations

While distributors share some responsibilities with importers, there are key differences. Importers, as per Article 13 MDR, have a more extensive verification role, particularly regarding the manufacturer's conformity assessment and documentation. Distributors, however, are focused on ensuring the device as supplied is compliant and that necessary documentation and information are present.

#Common mistakes in practice

• Assuming the CE mark guarantees full compliance: Relying solely on the CE mark without performing the checks stipulated in Article 14(2) MDR.
• Neglecting national language requirements: Not verifying that the Instructions for Use (IFU) and labelling are in the official language(s) required by the Member State where the device is made available.
• Insufficient checks on manufacturer/importer information: Failing to verify that the manufacturer and, where applicable, the importer's details are present on the device or its packaging as required.
• Inadequate documentation of checks: Not keeping records of the verification steps performed, which can be critical during audits or investigations by competent authorities.
• Delayed reporting of non-conformities: Not promptly informing the manufacturer, importer, or competent authority upon discovering a non-compliant device or a device posing a serious risk.
• Lack of clear internal procedures: Absence of documented internal processes for conducting the Article 14 checks and handling identified non-conformities.

#The Importance of Diligence

The CJEU ruling serves as a reminder that all economic operators, including distributors, have a distinct and non-delegable role in ensuring medical device safety and compliance within the EU. National competent authorities are empowered to enforce these obligations. Distributors must review their internal processes to ensure they align with the spirit and letter of the MDR and the CJEU's interpretation. For further details on specific obligations, refer to Distributor Obligations: Verifying Medical Devices Under MDR Article 14.

#Connecting to Digital Solutions

Managing the array of distributor obligations under the MDR can be complex. Digital solutions can aid in systematic record-keeping, tracking verification steps, and managing communication with manufacturers and importers. Platforms integrating regulatory requirements can streamline compliance processes and assist in maintaining the necessary documentation, enhancing an organisation's market surveillance capabilities. For more information, please see our features for compliance: https://eudamedai.com/#funkcije.

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