Can I apply for CE marking if I am a medical device distributor?
Yes, a distributor can apply for CE marking as a legal manufacturer under the EU Medical Device Regulation (MDR) if they take on the responsibilities of the legal manufacturer. Here are the key points to consider.
- Assumption of Responsibilities: The distributor must take on all responsibilities of a legal manufacturer. This includes ensuring that the medical device complies with all applicable requirements of the MDR.
- Technical Documentation: The distributor, now acting as the legal manufacturer, must compile and maintain the technical documentation required by the MDR. This documentation should include design, manufacturing processes, risk management, clinical evaluation, and post-market surveillance plans.
- Quality Management System (QMS): The distributor must establish and maintain a Quality Management System that meets the requirements of the MDR. This QMS should cover all aspects of the device’s lifecycle, including design, production, and post-market activities.
- Labeling and Identification: The medical device must be labeled with the distributor’s name and address as the legal manufacturer. The distributor must also ensure that the device is correctly classified and that the appropriate conformity assessment procedures are followed.
- Notified Body Involvement: Depending on the classification of the medical device, the distributor (as the new legal manufacturer) may need to involve a Notified Body to conduct the conformity assessment. The distributor will be responsible for interacting with the Notified Body.
- Declaration of Conformity: The distributor, as the legal manufacturer, must issue a Declaration of Conformity stating that the device meets all applicable requirements of the MDR.
- Registration and Vigilance: The distributor must register the device with the appropriate regulatory authorities and comply with post-market surveillance and vigilance requirements.
In summary, a distributor can apply for CE marking as a legal manufacturer under the EU MDR if they fully assume the responsibilities of a legal manufacturer. This includes ensuring compliance with all regulatory requirements, maintaining technical documentation, establishing a Quality Management System, and handling labelling, registration, and post-market obligations.
