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The European Medical Device Regulations (EUMDR) require medical devices to have a CE marking on their device to make them eligible to be marketed and sold in the European Union. The CE marking is an assurance that
This assures healthcare providers and customers that the product conforms to EU regulations regardless of where it was manufactured and that it is safe for use in the region.
The CE marking is required for all medical devices, whether being placed new in the market or after refurbishment. Only medical devices that are custom-made for clinical trials don’t need a CE mark.
Some of the prerequisites for achieving the CE marking include:
#1 - Classifying Correctly: The CE marking is only for medical devices. Therefore, the product must conform to the definition of a medical device. The regulations on medical devices and in vitro diagnostic medical devices clearly define the rules for classifying the device based on four risk classes in Annex VIII.
In MDR, it is categorized as classes I to III, and in IVD, as classes A to D.
The manufacturer of class I and class A devices are responsible for getting the CE marking for their products while the manufacturers of devices that have a higher risk need a notified body for the certification. Medical devices require technical documentation and quality control of processes and products to reduce the risk when using them. Notified bodies designated by the authorities help manufacturers with ensuring they conform to the requirements.
#2 - Make Sure Technical Documentation is Perfect: Annex I of MDD and IVDD specifies the general safety and performance requirements based on which the technical documentation must be written.
The document must include:
#3 - Declaring Conformity: On ensuring compliance with the safety and performance requirements and completing the technical documentation, a dated and signed declaration of conformity must be kept ready by the manufacturer certifying that the product complies with the executive order requirements. These documents must be easily accessible for 10 years in the case of non-implantable devices and IVDs, and for at least 15 years for implantable devices and submitted to the authorities on request.
#4 - Achieving The CE Mark: The device can be CE marked once the declaration of conformity is signed. The mark must be affixed to the device and the package in such a manner that it is visible, legible, and indelible. For devices certified by a notified body, the CE mark should include the identification number of the notified body that facilitated the product assessment.
510(k) is the regulatory requirement to market medical devices in the US. For devices that are estimated to have the same level of risk, a CE marking is needed to market in the European region.
The affixing can happen after the manufacturer has demonstrated compliance with the EU MDD and IVDD compliance.
Device classification varies for the US and European regulatory bodies and the categories do not map directly. Therefore, identifying the correct classification and justifying the correct directive and device risk classification is left up to the manufacturer. A notified body may be able to help with getting clarity on the classification.
While Class I devices without a measuring function and not requiring sterilization do not need to be audited, it may be needed for devices with higher risk levels and using a QMS. At least two audits will be required for such devices: one for reviewing the QMS procedures and ensuring that the quality manual complies with ISO 13485 and the associated directive. The second is a Technical File review and a facility/certification audit. While the QMS manual audit and technical file review may be performed remotely, facility/certification audit requires inspection of QMS records and facilities.
Moving to a cloud-based QMS platform such as ComplianceQuest can help medical device manufacturers streamline their quality management process to improve compliance and accelerate achieving the CE marking. The platform offers a variety of features that are aligned with the ISO standards, which forms the basis for all regulations. As a result, medical device manufacturers can be compliant from day one, right when they start planning to expand into the EU.
Some of the features that help with improved compliance and ensure quality, safety, and performance include:
To know more about the CQ EQMS solution and how it can facilitate achieving CE marking, visit: https://www.compliancequest.com/lp/eqms/
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