Fast track your CE marking.

If you are a U.S.-based manufacturer of Software as a Medical Device (SaMD) looking to commercialize your products in Europe, obtaining CE marking is a mandatory step. Compliance with the Medical Device Regulation (EU) 2017/745 (MDR) ensures that your software meets the required safety, performance, and regulatory standards for legal marketing in Europe. Below, we outline the key steps to achieve CE marking certification. Step 1: Implement a Quality Management System (QMS) – ISO 13485 Certification To comply with MDR, manufacturers must implement a Quality Management System (QMS) aligned with ISO 13485. This standard ensures that medical devices are consistently designed, developed, and maintained in accordance with regulatory requirements. For U.S.-based companies, the FDA’s Quality System Regulation (QSR) (21 CFR Part 820) is being updated to align more closely with ISO 13485, with the Quality Management System Regulation (QMSR) taking effect in 2026. However, compliance with ISO 13485 is mandatory for CE marking in Europe. Step 2: Determine Your SaMD classification under MDR 2017/745 and MDCG 2019-11 Rule 11 (Annex VII, chapter III) of the MDR 2017/745 determines the classification of SaMD based on their intended use and potential risks. Class I (Low-risk) – Software with no clinical decision-making role. Class IIa (Moderate risk) : Software that provides medical information used for diagnostic or therapeutic purposes but whose incorrect use is unlikely to cause serious harm. Class IIb (high risk) : Software that provides medical information that could result in serious health deterioration or require surgical intervention in the event of failure or incorrect use. Class III (critical risk) : Software that directly drives or influences medical decisions, where failure could result in death or irreversible health deterioration. Step 3: Prepare your Technical Documentation for CE Marking Your technical file must comply with MDR and includes the following essential documents: Device description, including qualification and classification according to MDR Rule 11. Software development lifecycle documentation (compliant with IEC 62304, IEC 82304). Clinical evaluation report and risk management (compliant with ISO 14971) demonstrating safety and performance. Post-market surveillance (PMS) plan and vigilance reporting system, including periodic safety update reports (PSURs). Labeling and instructions for use (IFU). Declaration of conformity. Usability engineering file (compliant with IEC 62366). UDI (unique Device identification) (see our article on UDI system ). Verification and validation reports. this is a non-exhaustive list, there are other documents that constitute the Technical File. Step 4: Choose a Notified Body (if applicable) For Class I medical devices, must self-certify compliance with MDR but are still required to register their device with the Competent Authority in the EU member state where their Authorized Representative (AR) is established. For Class IIa, IIb, or III SaMD, a Notified Body (NB) must validate MDR compliance by delivering the CE-marking certificate. Step 5: Register Your Company and Product on EUDAMED Under MDR, all manufacturers must register in EUDAMED, the European Database on Medical Devices, which centralizes information about economic operators, devices, and post-market surveillance. EUDAMED is designed to enhance transparency and traceability within the EU market. You and your Authorized Representative must both register in the Economic Operators module. Each device must be registered in the UDI/Device Registration module, ensuring compliance with MDR Article 27 on traceability. Conclusion For a U.S.-based SaMD company, entering the European market requires strict adherence to MDR 2017/745. The key steps include: Implementing ISO 13485 QMS. Classifying the SaMD under MDR. Preparing complete technical documentation. Obtaining CE certification (if required). Registering in EUDAMED. With the right regulatory approach, your software can successfully enter the European market.

In our previous article, we explored the key steps for US manufacturers of SaMD to obtain CE marking and enter the European market (see our article : “ How to Market Your Medical Device in Europe?”) . One of the requirements of the Medical Device Regulation (EU) 2017/745 (MDR) is the appointment of an Authorized Representative (AR). Indeed, non-European manufacturers must appoint an AR to liaise between the manufacturer and the European competent authorities. This role is essential to ensure compliance, manage regulatory obligations and facilitate market access. In this article, we examine the importance of appointing an authorized representative. Why Is an Authorized Representative Mandatory ? According to Article 11 of MDR, the AR serves as the legal representative of a non-EU manufacturer within the EU and carries several responsibilities: Verifying the Declaration of Conformity and the conformity of the Technical Documentation. Holding a copy of the Technical Documentation and make it available to Competent authorities. Cooperating with the Competent Authorities. Informing the manufacturer in case of an accident. ➡️ Without an AR, your software cannot be marketed in Europe. The AR is not the only one with responsibilities, the manufacturer (Non-EU Company) holds following obligations: Ensuring that the medical device complies with MDR requirements before placing it on the market. Establishing and maintaining a Technical Documentation in accordance with MDR. Implementing a Quality Management System (QMS) (compliant with the standard ISO 13485). Conducting clinical evaluations (both pre-market and post-market). Ensuring compliance with post-market surveillance (PMS) requirements. Registering the manufacturer and its devices in EUDAMED and ensuring UDI compliance.  Conclusion Entering the European market with a SaMD starts with obtaining CE marking. Only then can U.S. manufacturers appoint an Authorized Representative (AR), as required by the Medical Device Regulation (EU) 2017/745 (MDR). The AR plays a vital role in ensuring compliance and facilitating market access.