Maven is a leading regulatory consultancy offering a comprehensive one-stop solution for European regulatory approval 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.
Why European CE Marking Matters for Medical Device Manufacturers
- European regulatory approval is a prestigious mark for any medical device, assuring customers of its quality, safety, and efficacy. It ensures that medical devices comply with CE regulations in Europe, helping manufacturers build trust with consumers and healthcare providers.
- Obtaining CE certification in Europe allows manufacturers to access the entire European market, significantly expanding their business reach. In addition to Europe, many other countries recognize European CE approval as proof of product quality, simplifying the country registration process with reduced timelines and scrutiny.
- With increasing competition, manufacturers must maintain a competitive edge. Achieving CE approval in Europe enhances a medical device manufacturer’s reputation and boosts customer confidence. Today’s customers and end-users are more aware and cautious about the medical devices used on them or their patients. Having a device that meets European CE standards assures them of its safety and compliance.
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 European Commission approval of a medical device. 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.
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 still apply as the legal manufacturer under EU regulatory requirements. 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 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:
European CE Marking as per EU MDR 2017/745 Regulation
The European regulatory approval process under the EU 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:
- Check if your device falls under the definition of a medical device as per the EU 2017/745 implementing regulation.
- If your device qualifies as a medical device, classify it as per the EU MDR classification rules (Annex). Compile a technical file with relevant administrative, product-related, and technical details. Follow the General Safety and Performance Requirements (GSPR), identify applicable standards, and generate the required evidence, including MDCG documents.
- Ensure that risk assessment files and clinical evaluation data are sufficient to demonstrate performance, safety, and compliance with CE certification Europe regulations.
- Conduct an internal review to identify any gaps in documentation. If needed, seek expert consultation from Maven for a compliance check before submission to a Notified Body.
- Manufacturers outside the EU must appoint a European Authorized Representative and retain them throughout the validity of the certification.
- Contact a UDI issuing agency like HIBCC to assign a Basic UDI-DI for your product category and UDI-DI for individual products. Register your manufacturing organization on the EUDAMED portal to obtain a Single Registration Number (SRN).
- Identify an appropriate Notified Body authorized to assess your product type (listed under NANDO codes). Submit your application, obtain assessment timelines, and complete audits. Note that Class I devices without measuring functions, reusability, or sterility (Class Im, Class I, and Class Is) do not require Notified Body intervention and can proceed with self-declaration of conformity (DOC).
- Once the Notified Body issues a CE certificate (or after self-declaration for Class I devices), affix the CE mark European Union on your products.
- Continuously update technical documentation using post-market surveillance data. Annual surveillance audits will be conducted to ensure compliance until the certification remains valid (up to 5 years).
How Maven Can Help with Your European CE Marking Approval?
Though regulatory approval 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.
- 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 correlate 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 European CE approval 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 regulatory approval 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 CE approval in Europe.
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.
