The introduction of EU 2017/745 (“EU MDR”) has brought about significant changes within the medical device industry. The fundamental landscape of our industry has been altered as manufacturers continue to wrestle with the various requirements within this regulation, including the impact on the clinical evaluation process, post-market surveillance, the quality management system, EUDAMED, UDI, and product classification. In addition to these critical areas, the roles and responsibilities of the Authorized Representative (“AR”) have expanded dramatically under the EU MDR.
Any medical device manufacturer who wishes to sell its products in the European Union (“EU”) and does not have a physical location with the EU, must appoint an AR who is located within the EU. The AR serves as the manufacturer’s liaison with the applicable authorities to ensure ongoing compliance with European regulations. In general, the AR serves a number of important functions such as communicating directly with the competent authorities, assisting with device registrations, and maintaining a copy of documentation readily available for inspection by competent authorities. Further, the AR must be specifically identified on the product labeling within Europe.
The EU MDR has increased the legal exposure and burden of compliance on AR’s, in essence resulting in them being legally liable for defective devices potentially at the same level as the manufacturer itself. As a result, manufacturers should expect AR’s to be increasingly vigilant in their review of manufacturers’ practices and commitment to compliance. Further, it is essential that manufacturers are diligent and proactive in ensuring that their contracted AR fully understands its enhanced responsibilities including the need for the following actions, among others:
- Appoint a person responsible for regulatory compliance, or “PRRC”
- Confirm the proper registration of the device, the manufacturer, and the AR
- Review the Technical Documentation and Declaration of Conformity to confirm compliance
- Maintain all documentation and issued certificates from Notified Bodies in compliance with mandated timelines
- Ensure compliance with the Unique Device Identifier, or “UDI”
- Provide the necessary support for an audit by a competent authority
- Coordinate effectively with competent authorities to implement corrective actions
- Support vigilance reporting by providing clear and timely communication to manufacturers about complaints
Manufacturers should be aware that a competent authority can inspect an AR at any time to assess whether the AR fully understands its role, has effective practices in place for ongoing compliance with regulations, and maintains direct access to all pertinent documentation including technical files and design dossiers. Manufacturers are permitted to change the AR at their discretion, however since the AR is required to be included on product labeling, such changes could be time-consuming and costly.
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