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Maven is a leading regulatory consultancy offering a comprehensive one-stop solution for European CE marking of medical devices. 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 CE certification European Union requirements. 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 EU CE marking consultants, ensuring a smooth pathway to CE mark European Union approval 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 European Commission approval of a medical device(s). For manufacturers within the EU region, obtaining CE European Union certification is mandatory to comply with the law and adhere to the EU CE Mark medical device regulation. Manufacturers outside the EU region can decide to pursue European CE Mark medical device approval if they aim to sell their devices in European countries or other markets that recognize the CE European Standard.
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 European CE marking process under the EU CE marking framework has undergone significant changes compared to the previous MDD directive. The CE certification European Union now places greater emphasis on product safety and efficacy to ensure patient protection.
The ideal steps to begin any CE mark European Union process are as follows:
Though CE marking can be achieved by following the steps mentioned, what makes the process complicated for manufacturers is the interpretation of CE regulations in Europe and ensuring compliance.
At Maven, we assist manufacturers in navigating the complexities of European CE standards, ensuring a smooth path toward regulatory compliance and successful certification.
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.
The cost of CE marking certification for medical devices can vary significantly depending on several factors, including the device classification, complexity, scope of required testing, and involvement of a Notified Body. Class I devices that qualify for self-declaration generally incur lower costs, as they do not require Notified Body assessment. However, higher-risk devices (Class IIa, IIb, III) require a Notified Body’s involvement, which adds to the overall expense due to conformity assessments, audits, and technical documentation reviews.
Additional costs may include fees for external laboratory testing, clinical evaluations, UDI, EUDAMED registration, and the appointment of a European Authorised Representative.
Maven offers tailored consultancy to evaluate your specific device requirements and provide a detailed cost estimate.
A Notified Body is an independent organisation designated by European Union member states to assess the conformity of medical devices before they can be CE marked. Their primary role is to evaluate whether a medical device meets the relevant requirements of the EU Medical Device Regulation (EU MDR 2017/745).
The Notified Body reviews the manufacturer’s technical documentation, conducts audits, and performs or oversees necessary testing. For higher-risk devices (Class IIa, IIb, and III), their approval is mandatory before the CE mark can be affixed. They issue the CE certificate once all regulatory criteria are met.
Additionally, the Notified Body monitors manufacturers through periodic surveillance audits during the certification validity period.
To obtain CE certification under the EU Medical Device Regulation (MDR 2017/745), manufacturers must prepare and maintain a comprehensive Technical Documentation (also called a Technical File or Technical Dossier) that includes:
1. Device Description and Specification, including detailed information about the device, including intended use, variants, and accessories.
2. Risk Management File in compliance with ISO 14971.
3. Clinical Evaluation Report (CER)
4. General Safety and Performance Requirements (GSPR) as per Annex I of the MDR.
5. Labels and Instructions for Use (IFU)
6. Details of the design, manufacturing processes, and quality management systems.
7. Post-Market Surveillance Plan
8. Declaration of Conformity (DoC)
9. If applicable, documents from the notified body, including conformity assessment reports and issued certificates.
10. Information related to UDI assignment and registration on the EUDAMED database.
These documents collectively provide the evidence required for conformity assessment.
Medical device consultants play a vital role in guiding manufacturers through the complex CE certification process. They help interpret and apply the detailed requirements of the EU Medical Device Regulation (EU MDR), ensuring that your technical documentation meets the latest European standards. Consultants assist in identifying the external testing and coordinate with trusted laboratories to obtain reliable results. They provide support in compiling and reviewing technical files, addressing queries from notified bodies, and managing the certification workflow.
Consultants offer guidance on crucial steps such as Unique Device Identifier (UDI) generation, EUDAMED registration, and appointing a European Authorized Representative. Their expertise helps avoid common pitfalls and delays, making the path to CE mark approval smoother and more efficient.
Yes, a distributor can apply for CE marking only if they take on the responsibilities of a legal manufacturer under EU MDR Article 16. This means they must ensure the product meets all applicable regulatory requirements, maintain technical documentation, conduct conformity assessments, and be listed as the legal manufacturer on the product label. In such cases, the distributor is treated as the manufacturer and must fully comply with EU MDR obligations to obtain CE marking.
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