Responsibilities of Economic Operators Under the Medical Device Regulation (MDR)

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The European Union’s Medical Device Regulation (MDR), which came into full effect on May 26, 2021, establishes stringent requirements to ensure the safety, performance, and quality of medical devices in the EU market. Economic operators, including manufacturers, authorized representatives, importers, and distributors, play pivotal roles in ensuring compliance. This article explores the responsibilities of these key players under the MDR.

1. Manufacturers

Manufacturers are at the heart of the regulatory framework and hold the primary responsibility for the compliance of their medical devices. Their key obligations include:

  • CE Marking: Manufacturers must ensure that their devices meet the essential safety and performance requirements outlined in Annex I of the MDR and affix the CE mark accordingly.
  • Technical Documentation: Comprehensive technical documentation must be prepared in accordance with MDR Annex II and III, including risk analysis described in Section 3 of Annex I, clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF, and performance testing data, to demonstrate conformity.
  • Quality Management System (QMS): Implementing and maintaining an effective QMS in accordance with MDR Annex IX and ISO 13485 is mandatory.
  • Post-Market Surveillance (PMS): Manufacturers must establish and execute a PMS plan to continuously monitor the performance of their devices.
  • Incident Reporting: Serious incidents and field safety corrective actions (FSCA) must be reported to the relevant competent authorities in accordance with Article 87 and Article 89.
  • Unique Device Identification (UDI): Manufacturers are required to assign and maintain UDIs for their devices to ensure traceability in accordance with MDR Article 27 and with the registration obligations referred to in MDR Articles 29 and 31.
  • Provision of Technical Documentation: Manufacturers must provide technical documentation in full or as a summary upon request by a competent authority, as specified.
  • Retention of Documentation: General Devices: Manufacturers must retain technical documentation, the EU declaration of conformity, and relevant certificates (including amendments) for at least 10 years after the last device covered by the declaration has been placed on the market.
  • Implantable Devices: The retention period extends to 15 years for implantable devices.These documents must be made available to competent authorities during this period.
  • Accompanying Information: Devices must include the information specified in Section 23 of Annex I, in the official language(s) of the Member State where the device is available. Labels must be indelible, legible, and comprehensible.
  • Non-Conformity Action: If a device is non-compliant, manufacturers must take corrective action (conformity, withdrawal, or recall). They must inform distributors, authorized representatives, and importers. If the device poses a serious risk, they must notify competent authorities and notified bodies with details of non-compliance and actions taken.
  • Incident Reporting:Manufacturers must maintain a system to record and report incidents and safety corrective actions as per Articles 87 and 88.
  • Information and Documentation:Upon request, manufacturers must provide authorities with all necessary documentation to demonstrate compliance, in the official language of the Member State. They must also cooperate with authorities on corrective actions and provide free samples or access to the device when requested.
  • Cooperation with Authorities:If a manufacturer fails to cooperate or provides incomplete information, competent authorities may restrict, withdraw, or recall the device to protect public health and safety. Authorities may share relevant information with affected parties in compliance with data protection and intellectual property rules.
  • Third-Party Involvement:If devices are designed or manufactured by another entity, the identity of this entity must be included in the submission under Article 30(1).
  • Liability and Financial Coverage: Manufacturers must ensure financial coverage for potential liability under Directive 85/374/EEC, proportionate to the risk class, device type, and company size. This is without prejudice to stricter national laws.
  • Compensation for Damages:Natural or legal persons may claim compensation for damages caused by defective devices under applicable Union and national laws.

2. Authorized Representatives

Authorized representatives act on behalf of non-EU manufacturers to ensure compliance with the MDR. Their responsibilities include:

Designation and Mandate:

  • Devices from manufacturers outside the EU can only enter the EU market if a sole authorised representative is designated.
  • The designation is valid when accepted in writing and applies to all devices within the same generic group.
  • The mandate outlines the authorised representative’s tasks and must be provided to competent authorities upon request.

Mandatory Tasks:
The authorised representative must:

  • Verify the preparation of the EU declaration of conformity, technical documentation, and completion of conformity assessments by the manufacturer.
  • Retain copies of technical documentation, the EU declaration of conformity, and relevant certificates for at least 10 years (15 years for implantable devices) retention period.
  • Comply with and verify the manufacturer’s adherence to registration obligations (MDR Articles 27, 29, and 31).
  • Provide information and documentation to competent authorities in the required language upon request.
  • Facilitate access to devices or samples requested by competent authorities and verify delivery.
  • Cooperate with authorities on preventive or corrective actions to manage device risks.
  • Forward complaints and incident reports to the manufacturer.
  • Terminate the mandate if the manufacturer breaches its obligations and inform the competent authority and, if applicable, the notified body.

 Liability:

  • The authorised representative cannot assume the manufacturer’s obligations under MDR Article 10(1-4, 6-7, 9-12).
  • If the manufacturer does not comply with MDR Article 10, the authorised representative is jointly and severally liable for defective devices.

Mandate Termination:

  • If the mandate is terminated due to the manufacturer’s non-compliance, the authorised representative must inform the competent authority of its registered Member State and, if applicable, the notified body.

Competent Authority Reference:

  • Any reference to the competent authority of the manufacturer’s location in the Regulation applies to the competent authority where the authorised representative is based.

3. Importers

Importers ensure that devices entering the EU market comply with MDR requirements. Their key duties include:

  • Verification of Compliance: Confirming that the manufacturer has fulfilled all regulatory requirements, including CE marking and UDI assignment in accordance with Article 27.
  • Identification of Manufacturer and Authorised Representative: Ensuring a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer.
  • Labeling and Instructions: Ensuring that devices are properly labeled and accompanied by the required instructions for use in the EU’s official languages.
  • Traceability: Maintaining records of the devices they import, including the name and address of the supplier and customers.
  • Post-Market Obligations: Informing the manufacturer and competent authorities of any non-conformities or complaints.
  • Identification:Importers must provide their name, trade name or trademark, registered business address, and contact details on the device, packaging, or accompanying documents without obscuring the manufacturer’s information.
  • Device Registration:Importers must verify that the device is registered in the electronic system (per Article 29) and add their details to the registration (per Article 31).
  • Storage and Transport:Importers must ensure storage and transport conditions comply with safety and performance requirements and follow the manufacturer’s conditions.
  • Complaint and Recall Management:Importers must maintain a register of complaints, non-conforming devices, and recalls, and share relevant information with manufacturers, representatives, and distributors.
  • Non-Conformity Action:If a device is non-compliant, importers must immediately inform the manufacturer and authorized representatives, cooperate to ensure corrective action, and notify competent authorities and notified bodies if the device presents a serious risk.
  • Incident Reporting:Complaints or incident reports from healthcare professionals, patients, or users must be forwarded to the manufacturer and authorized representatives.
  • Document Retention:Importers must retain copies of the EU declaration of conformity and relevant certificates (with amendments) as required by Article 10(8).
  • Cooperation with Authorities:Importers must cooperate with authorities to eliminate or mitigate device risks and, upon request, provide free samples or access to the device.

4. Distributors

Distributors play a critical role in the supply chain, ensuring that devices remain compliant during distribution. Their responsibilities include:

General Duty of Care
Distributors must act diligently to ensure compliance with applicable requirements before making a device available on the market.

Pre-Market Verification
Before distributing a device, distributors must ensure:

  • The device is CE marked and has an EU declaration of conformity.
  • It is accompanied by information as required under Article 10(11).
  • Importers have met their obligations under Article 13(3) for imported devices.
  • A UDI (Unique Device Identifier) is assigned, where applicable.
    Distributors may use representative sampling to verify these requirements.

Non-Conformity and Serious Risks

  • Distributors must not market non-compliant devices and should inform the manufacturer, authorised representative, and importer of any non-compliance.
  • If a device presents a serious risk or is falsified, distributors must notify the competent authority of the Member State.

Storage and Transport Conditions
Devices must be stored and transported according to the manufacturer’s specified conditions.

 Complaints and Incident Reporting

  • Distributors must forward complaints or suspected incidents from healthcare professionals, patients, or users to the manufacturer and, where applicable, the authorised representative and importer.
  • They must maintain a register of complaints, non-conforming devices, recalls, and withdrawals, and provide updates to the manufacturer and other relevant parties upon request.

Cooperation with Authorities

  • Distributors must provide competent authorities with requested information and documentation to demonstrate device conformity.
  • They must cooperate with authorities to address risks posed by devices, including providing free samples or granting access to devices if necessary.

Corrective Actions:

Distributors must assist manufacturers and other relevant parties in taking corrective actions, such as bringing a device into conformity, withdrawal, or recall.

5. Common Obligations Across All Operators

Certain responsibilities are shared among all economic operators under the MDR, including:

  • Vigilance: Monitoring for potential issues or non-conformities in the devices and reporting them promptly.
  • Traceability: Maintaining records to enable the identification of the source and destination of devices.
  • Market Surveillance: Cooperating with competent authorities to withdraw or recall non-compliant or unsafe devices.

Economic operators have a crucial role in ensuring that medical devices placed on the EU market comply with the MDR’s stringent requirements. By adhering to their respective responsibilities, manufacturers, authorized representatives, importers, and distributors contribute to the overall goal of safeguarding public health and maintaining the integrity of the medical device industry.anges in accordance with regulatory guidelines to ensure the continued effectiveness and safety of the sterilization process for the medical device. 

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