Why the CE mark alone is not evidence of conformity

This article outlines the obligations for distributors and importers regarding the verification of medical devices and in vitro diagnostic medical devices. It explains why relying solely on the CE marking is insufficient and details the steps required to ensure compliance under EU regulations.

#The Role of the CE Mark

The CE marking indicates that a medical device or in vitro diagnostic medical device complies with the applicable European Union legislation. For medical devices, this is Regulation (EU) 2017/745 (MDR). For in vitro diagnostic medical devices, it is Regulation (EU) 2017/746 (IVDR). The manufacturer is responsible for affixing the CE mark after demonstrating conformity with the relevant regulation. This includes fulfilling general safety and performance requirements, implementing a quality management system, and conducting a conformity assessment procedure.

However, the CE mark itself is a declaration by the manufacturer. It does not automatically guarantee that all other regulatory obligations have been met by all economic operators in the supply chain.

#Obligations for Distributors and Importers

Distributors and importers are key economic operators in the medical device supply chain. They have specific, stringent obligations under the MDR and IVDR that extend beyond simply handling CE-marked products. These obligations aim to ensure that only compliant devices are placed on the market and made available to end-users.

#Obligations of Distributors

Before making a device available on the market, distributors must verify several aspects. Article 14(2) MDR and Article 11(2) IVDR state that a distributor must verify that:

• The device has been CE marked.
• A declaration of conformity has been drawn up.
• The device is accompanied by the information supplied by the manufacturer in accordance with Article 10(11) MDR or Article 10(10) IVDR, in an official EU language determined by the Member State where the device is made available to the user. This information must be clear, understandable, and legible.
• Where applicable, the manufacturer has assigned a UDI (Unique Device Identification) to the device. The UDI must be correctly affixed.
• The manufacturer has complied with the requirements set out in Article 10(6) and Article 10(7) MDR or Article 10(5) and Article 10(6) IVDR concerning implant cards (where applicable) and the registration of devices and economic operators in EUDAMED.

Distributors must also ensure that storage and transport conditions are appropriate and do not jeopardise compliance with the general safety and performance requirements. This is specified in Article 14(3) MDR and Article 11(3) IVDR.

#Obligations of Importers

Importers have additional responsibilities, as they are the first economic operator to bring a device from a third country into the EU market. Article 13(2) MDR and Article 10(2) IVDR mandate that before placing a device on the market, importers must verify that:

• The device has been CE marked.
• A declaration of conformity has been drawn up.
• The manufacturer is identified and has designated an authorised representative, as required.
• The device is labelled in accordance with the MDR or IVDR and is accompanied by the required instructions for use.
• A UDI has been assigned by the manufacturer.
• The manufacturer has fulfilled its obligations concerning device and economic operator registration in EUDAMED.

Importers must also verify that the manufacturer has established a quality management system and has performed a conformity assessment procedure. This is a more in-depth check compared to a distributor's obligation.

#Practical Steps for Verification

To fulfil these obligations, distributors and importers must implement robust internal procedures. These procedures should cover the entire process from device receipt to distribution.

#Documentation Review

• Declaration of Conformity (DoC): Obtain and review the manufacturer's DoC. Confirm it is valid, complete, and references the correct regulation (MDR or IVDR).
• Instructions for Use (IFU) and Labelling: Verify that the IFU and labelling are present, legible, and in the official language(s) required by the Member State of distribution. This often requires checking national requirements, as languages may vary. Ensure all legally required symbols and information are present.
• UDI Information: Check for the presence and correctness of the UDI on the label or packaging. For medical devices, this is particularly important for traceability. The UDI database is an essential tool for this verification.
• Authorised Representative: Confirm the presence and contact details of the authorised representative on the label or accompanying documentation, if the manufacturer is outside the EU.

#Physical Inspection

• CE Mark: Confirm the CE mark is visibly and legibly affixed to the device or its sterile packaging, and to the packaging for placing on the market, as per Article 20 MDR/IVDR. Ensure it is not obscured or ambiguous.
• Packaging Integrity: Inspect packaging for damage or signs of tampering that could affect device safety or performance. This is a critical part of Incoming Goods Inspection for Medical Devices: A Repeatable Verification Process.
• Device Condition: Conduct a visual check of the device itself (where possible without compromising sterility) for obvious defects or non-conformities.

#EUDAMED Checks

Distributors and importers must verify that manufacturers have registered devices and economic operators in EUDAMED. The EUDAMED database contains information on medical devices, in vitro diagnostic devices, economic operators, clinical investigations, performance studies, and certificates. Access to specific modules for public use has been phased in. Rules around the EUDAMED modules have changed in stages, so the reader should confirm the current status and scope with their national competent authority.

#Dealing with Non-Conformities

If, at any stage, a distributor or importer identifies that a device is not in conformity with the MDR or IVDR, they must take immediate action. This includes not making the device available on the market and informing the manufacturer and, where applicable, the authorised representative. The distributor or importer must also inform the competent authority of the Member State where they detected the non-conformity. These obligations are detailed in Article 14(4) MDR, Article 11(4) IVDR, Article 13(4) MDR, and Article 10(4) IVDR.

#Common mistakes in practice

• Assuming the CE mark alone guarantees full compliance, neglecting detailed checks.
• Failing to verify the presence and validity of the Declaration of Conformity.
• Not checking if the Instructions for Use and labelling are in the correct national language(s).
• Insufficiently checking for the UDI or its correctness.
• Lack of documented procedures for incoming goods inspection and verification.
• Failure to inform national competent authorities of identified non-conformities.
• Not understanding the specific national requirements for device labelling and information.
• Ignoring the need to verify manufacturer registration in EUDAMED (when publicly accessible).
• Lack of a robust How to define and document a sampling method for medical devices under MDR for verification activities.

#Conclusion

The responsibilities of medical device distributors and importers are integral to ensuring public health and safety within the European Union. The CE marking is a prerequisite but requires further verification steps to ensure complete regulatory compliance. Diligence in documentation review, physical inspection, and adherence to EUDAMED requirements is paramount. Compliance with these obligations protects patients and safeguards the integrity of the medical device supply chain. Platforms like EUDAMED.AI can support these verification processes by facilitating access to relevant data and maintaining up-to-date regulatory information, complementing the work of compliance professionals. Learn more about how EUDAMED.AI helps with regulatory compliance: https://eudamedai.com/#kako-deluje

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