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European CE Marking For Medical Device Consultants

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    Maven is a leading regulatory consultancy offering a comprehensive one-stop solution for the European CE mark medical device certification. Our expert team provides end-to-end support with technical documentation preparation, ensuring compliance with the latest European standards. We assist in identifying external testing requirements and coordinate seamlessly with our trusted laboratory partners to achieve accurate and reliable results. Maven also facilitates the generation of Unique Device Identifiers (UDIs) and provides guidance for EUDAMED registration to meet regulatory obligations. Additionally, we manage the appointment of an EC REP (European Authorised Representative) and handle all communication with the notified body. With a strong focus on efficiency, compliance, and client satisfaction, Maven stands out among CE mark medical device consultants, ensuring a smooth pathway to CE marking and enabling your medical devices to enter the European market with confidence.

    How is European CE marking of medical devices useful for manufacturers?

    • European CE marking is a prestigious mark for any medical device to have and it assures customers of the product quality, safety and efficacy. It ensures that the medical devices meet the necessary standards and regulations, which helps in building trust with consumers and healthcare providers.
    • CE marking a medical device allows access to the entire European market and offer manufacturer significant business reach. Along with Europe, there are many other countries that accept CE marking as a concrete proof of product quality and country registration process in those countries becomes very easy and with significantly reduced timelines and scrutiny.
    • With increased competition it is very important that manufacturers have competitive advantage over other medical device manufacturers. Having a CE mark on their medical device will enhance their reputation and increase customer confidence on their medical device.
    • Customers and end-users these days have become aware and are concerned about what medical device is being used on them or on their patients and having a CE marked medical device gives them assurance of device safety.

    Who can apply for European CE Marking of Medical Devices?

    Any medical device manufacturer, whether based within or outside the EU region, can apply for CE marking of a medical device(s). For manufacturers within the EU region, obtaining European Union CE Mark approval is mandatory to comply with the law and adhere to the EU regulation. Manufacturers outside the EU region can decide to pursue European CE Mark approval if they aim to sell their devices in European countries or other markets that recognize CE marking.

    Can I apply CE Mark Approval if I Subcontract Manufacturing to an OEM?

    If you subcontract manufacturing to an Original Equipment Manufacturer (OEM), you can always apply for CE marking as a legal manufacturer. Please click on this link to know some key points to consider in such a scenario:

    Can I Get CE Marking as 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. as stated in article 16 of EU MDR Cases in which obligations of manufacturers apply to importers, distributors or other persons Please click on this link to know some key points to consider in such a scenario:

    CE-Marking-For-Medical-Devices

    European CE Marking as per EU MDR 2017/745 Regulation

    The CE marking process as per EU MDR Regulation is significantly different than what has been in practice under the MDD directive. The EU MDR demands for the right approach with more focus on product safety and efficacy to ensure patient safety.

    The ideal steps to begin any CE marking process are as below:

    • Check If your device falls under the definition of a medical device as provided by EU 2017/745 implementing regulation.
    • If this device qualifies as a medical device the next step would be to classify the device as per classification rules mentioned in the EU MDR (Annex). You can also use technical file with relevant technical, administrative and product related information. Follow the General Safety and Performance Checklist (GSPR) and identify applicable standards, MDCG documents and generate the required evidence.
    • Check if the risk assessment files and the clinical evaluation of the product is adequate to demonstrate performance and safety and shows acceptable level of compliance as per EU regulations.
    • Internally assess the documents for any gaps and if required outsource the gap analysis of your documents to Maven to ensure compliance before submission to the notified body.
    • For manufacturers based outside of the EU region, it is mandatory to appoint a European Authorised Representative and retain the same till the certification validity.
    • Contact a UDI issuing agency like HIBCC, to assign the basic UDI-DI for your product category and UDI-DI for your products.
    • Register your manufacturing organisation on the EUDAMED portal and obtain manufacturers Single Registration Number (SRN).
    • Find the appropriate notified body that is eligible to assess your product type. You can find the same in their list of NANDO codes. Make the application to them and get the assessment timelines and audit details. Please note Class I devices that do not have a measuring function (Class Im), or are not re-usable (Class I) or are not sterile surgical instruments (Class Is) don’t require notified body intervention and can carry on with self-declaration of conformity (DOC).
    • Affix CE mark on your products (After notified body issues a CE certificate/after self-declaration for Class I devices.
    • Continually update relevant technical documents through Post Market Surveillance data.
    • An annual surveillance audit takes place every year after the certification audit to ensure continued compliance till the validity of the certificate i.e. 5 years.

    How Maven Can Help with Your European CE Marking Approval?

    Though CE marking can be achieved by following the steps mentioned, what makes the process complicated for manufacturers is the interpretation of regulatory requirements and ensuring compliance.

    • Interpreting the EU MDR Regulation: The EU MDR is complex and doesn’t provide a straightforward conclusion on what is applicable or required for a specific product. Manufacturers must co-relate different sections of the regulation to determine the applicable requirements. This makes it crucial to adopt a systematic approach to reading, understanding, and concluding the requirements to ensure compliance with the European CE mark for medical devices.
    • Navigating Multiple MDCG Guidelines: The European Commission has released hundreds of MDCG guidelines to help manufacturers understand the requirements of this vast regulation. However, identifying and implementing the appropriate guidelines can be overwhelming and time-consuming, especially for those unfamiliar with the documentation.
    • Limited Experience with Notified Body Assessments: Manufacturers new to the CE marking process often face challenges in understanding the requirements outlined by notified bodies. They may struggle to address their concerns effectively, even with established systems and processes, leading to delays or potential failures in obtaining European Commission CE marking approval.

    Here comes into the picture consultation services like ours that help manufacturers navigate all the above-mentioned drawbacks effectively. We provide comprehensive support for the preparation of technical documents, ensuring accuracy and compliance. Our team assists in performing the correct external testing, compiling the technical files as required by a notified body, addressing their concerns, and providing robust audit support. We specialize in helping manufacturers achieve the European CE Mark for medical devices, ensuring they meet regulatory standards. Our services are highly customizable, catering to medium and small-scale manufacturers with end-to-end solutions. For multinational organizations, we offer tailored support focused on specific areas such as clinical evaluations, risk assessments, or gap analysis. With extensive experience in the European Union CE Mark process, we ensure manufacturers gain regulatory approval efficiently. Our expertise enables us to streamline every aspect of the certification process, helping clients meet compliance requirements and achieve their goals.

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