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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.
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.
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:
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:
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:
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.
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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