Can I apply for CE marking if I subcontract my manufacturing activities to an OEM?
If you subcontract manufacturing to an Original Equipment Manufacturer (OEM), you can always apply for CE marking as a legal manufacturer. When the entire manufacturing is outsourced, the subcontractor under the EU MDR is known as Private Label Manufacturer (PLM) or “own brand labeller” (OBL). A “private label manufacturer” (PLM) or “own brand labeller” (OBL) that markets, under its own name or trademark, a device manufactured by a third party is therefore to be regarded as the (legal) manufacturer within the meaning of the MDR. The OEM/PLM relationship is completely possible. Here are some key points to consider in such a scenario:
- As the legal manufacturer (the entity under whose name the device is placed on the market), the PLM/OBL is responsible for ensuring that the device complies with all relevant EU regulations, regardless of whether the actual manufacturing is subcontracted to an OEM.
- It is the responsibility of the legal manufacturer (“private label manufacturer” (PLM) or “own brand labeller” (OBL) to collect or prepare and maintain important technical documentation that are needed to demonstrate compliance with the EU MDR. This will include design files, manufacturing related documents, risk assessments, clinical evaluations, usability studies, post market surveillance documents (PMS, PSUR, PMCF) and other related quality management system and technical data. Regardless of these activities being performed by the Original Equipment Manufacturer (OEM), the legal manufacturer is responsible for compiling and maintaining these documents and demonstrating compliance to the notified body.
- Agreement/contract has to be in place between the OEM and the subcontractor (“private label manufacturer” (PLM) or “own brand labeller” (OBL) defining roles, responsibilities, and obligations. As a part of the CE marking process, the notified body will also audit the OEM and hence the OEM must agree to comply and provide necessary QMS and technical documents and be open to audit and assessment by the notified body.
- The Legal manufacturer “private label manufacturer” (PLM) or “own brand labeller” (OBL) in this case shall have a well-documented Quality Management System in place complying with the requirements of ISO 13485 and EU MDR. The QMS should demonstrate adequate control over the design, manufacturing, and post market surveillance activities. The QMS of the OEM should also align with the QMS of the legal manufacturer. The manufacturer is also responsible to have control and also inspect the OEM’s processes to ensure compliance with regulatory standards. This helps ensure that the manufacturing processes meet the required quality and safety standards.
- The device should be labelled with the legal manufacturers “private label manufacturer” (PLM) or “own brand labeller” (OBL) name and address and they must also issue the Declaration of Conformity, which states that the device meets all applicable EU requirements.
In conclusion, as the legal manufacturer, the “private label manufacturer” (PLM) or “own brand labeller” (OBL) can apply for CE marking of medical device when subcontracting manufacturing to an OEM. However, you must ensure compliance with all regulatory requirements, maintain control over the technical documentation, and oversee the quality and conformity of the OEM’s manufacturing processes.
