CE Marking for Medical Devices: Automate Processes to Comply with EU Regulations
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
- The device meets the General Safety and Performance Requirements (GSPR)
- It has been classified properly as per regulations
- And, it conforms to the appropriate assessment route for the product
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.
The Process of Getting the CE Marking: 4 Key Steps
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.
- Lowest Risk: Devices with low risk are classified as Class I in MDD and Class A in IVDD.
- Medium Risk: Devices with medium risk fall under Class II or Class B.
- High Risk: Such devices are classified as Class III or Class 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:
- Detailed assessment of the product’s quality, safety, and performance.
- A clinical evaluation that establishes the compliance of the device to the GSPR based on the analysis of clinical data from different relevant sources such as scientific journals, clinical investigations, and performance studies (for IVDs). This helps to establish the tolerance threshold of risks when weighed against the benefits of using the device.
- Risk analysis describes the risks associated with the intended use of the medical device and is a critical component of the technical documentation. It helps to assess the acceptability of the risk and must be performed on an ongoing basis whenever a change is made that could potentially change the product’s risk profile.
#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.
Medical Device 510(k) vs. CE Marking: Classification May Be Different
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:
- Document: From creating the documents to storing, updating, and managing them, ComplianceQuest EQMS provides a centralized solution that makes accessing and demonstrating compliance easy.
- Audit: Build a flexible, scalable, and configurable audit management workflow best suited for your organization. Automate a rapid audit process and configure workflows for complex audits. Quality and safety leaders can set up yearly or quarterly calendar views that enable all stakeholders to be alerted about scheduled audits and prepare accordingly. It also empowers them to flexibly choose between complex, stringent, or streamlined audits.
- Design Control: Bring higher quality products to market quicker with full compliance and comprehensive documentation. Help your quality and engineering teams stay in sync with a single source of truth for all your product design activities. Remove the headache of documentation and compliance from your product design process with living and always-up-to-date design files which are shareable with the click of a button.
- Risk: Maintain a centralized repository of identified risks at the project, department, or company level. Drive strategic decisions on potential threats based on the latest standards such as ISO 31000, ISO 14971, ICH Q9, and risk principles in ISO 9001:2015, ISO 13485:2016, ISO 45001, and ISO 14001 to help accelerate assessments, identify, and analyze risk trends and drive risk mitigation activities.
- Management Review: Improve management reviews to meet regulatory requirements and ensure all key stakeholders have a clear picture with regards to risks and impacts and collaborate effectively to improve overall quality and safety performance.
- Nonconformance: Capture, triage, investigate, and close nonconformances quickly and effectively to reduce the cost of poor quality.
To know more about the CQ EQMS solution and how it can facilitate achieving CE marking, visit: https://www.compliancequest.com/lp/eqms/