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European CE Marking For Medical Devices

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    Maven is a regulatory consultancy providing one-stop solution for the CE marking of your medical devices, providing overall support with technical documentation, identification of external testing and coordination with associate laboratory partners, generating UDI’s, EUDAMED registration, appointment of EC REP (European Authorised Representative) and coordination with notified body.

    How is 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 based within or outside the EU region can apply for CE marking of a medical device(s). For the manufacturers based in the EU region, it is mandatory to follow the law of the land and comply with the EU regulation. Manufacturers based outside the EU region can choose if they are looking to sell in European countries or many other countries that accept CE marking and accordingly decide to choose CE marking.

    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. Please click on this link to know some key points to consider in such a scenario:

    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. 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?

    Though CE marking can be done by following the above mentioned steps, what makes the process complicated for manufacturer interpret is

    • The appropriate interpretation of the EU MDR regulation. The Regulation doesn’t have a straight forward conclusion on what is applicable or required but one has to co-relate different sections on the regulation to conclude on what requirements are applicable to their product making it extremely important to have a correct approach of reading, understanding and concluding the requirements.
    • Multiple MDCG guidelines. To understand the requirements of this vast regulation, the EU commission has released hundreds of MDCG guidelines that cover information regarding various sections of the regulation and it can be overwhelming to have a hold of these guidelines and identify and implement the appropriate ones.
    • Lack of previous exposure to notified body assessment. Many manufacturers are new to the CE marking process and may struggle in understanding the requirements put up by the notified body and not be able to answer or address their concerns/questions to the best of their knowledge, leading to failure even after having systems and processes in place.

    Here comes into picture, consultation services like ours that help manufacturers through all the above mentioned drawbacks and foster support for preparation of technical documents, performance of the correct external testing, compiling the technical files as notified body would like them, answer to notified body concerns and provide audit support. Our services are customizable and can cater to the need of medium and small scale manufacturers with and end-to-end support or provide small customisable services to multinationals that require support specific to clinical evaluations, risk assessment or gap analysis.

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