Bringing your SaMD to Europe: the essential steps for CE marking compliance

If you are a US-based manufacturer of Digital Medical Devices (DMD) looking to commercialise your products in Europe, obtaining CE marking is a mandatory step. Compliance with the Medical Devices Regulation (EU) 2017/745 (MDR) ensures that your software meets the required standards in terms of safety, performance and regulation for legal commercialisation in the European Union. Here are the key steps to obtain CE marking:

Step 1: Set up a Quality Management System (QMS) – ISO 13485 certification
To comply with the MDR, manufacturers must implement a QMS compliant with ISO 13485. This standard ensures that medical devices are systematically designed, developed and maintained in accordance with regulatory requirements.

For US companies, the FDA's Quality System Regulation (QSR – 21 CFR Part 820) is being updated to align more closely with ISO 13485, with the entry into force of the Quality Management System Regulation (QMSR) planned for 2026. However, compliance with ISO 13485 remains mandatory for CE marking in Europe.

Step 2: Determine the classification of your SaMD under MDR 2017/745 and MDCG 2019-11
Rule 11 (Annex VII, chapter III) of 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 providing medical information used for diagnostic or therapeutic purposes, the incorrect use of which is unlikely to cause serious harm.
• Class IIb (High risk) – Software providing medical information that may lead to serious deterioration of health or require surgical intervention in case of failure or incorrect use.
• Class III (Critical risk) – Software that directly drives or influences medical decisions, the failure of which could result in death or irreversible deterioration of health.

Step 3: Prepare your Technical Documentation for CE marking
Your Technical File must comply with the MDR and include the following essential documents:

• Device description, including qualification and classification under rule 11 of the MDR.
• Software development lifecycle documentation (compliant with IEC 62304, IEC 82304 standards).
• Clinical evaluation report and risk management (compliant with ISO 14971) demonstrating safety and performance.
• Post-market surveillance (PMS) plan and incident reporting system, including periodic safety update reports (PSURs).
• Labelling and instructions for use (IFU).
• Declaration of conformity.
• Usability engineering file (compliant with IEC 62366).
• Unique Device Identification (UDI) (see our article on the UDI system).
• Verification and validation reports.

This is a non-exhaustive list; other documents may also make up the technical file.

Step 4: Choose a Notified Body (if applicable)
For Class I medical devices, self-certification of MDR compliance is possible, but they must still register their device with the Competent Authority of the EU Member State where their Authorised Representative is established.
For Class IIa, IIb or III SaMD, a Notified Body (NB) must validate MDR compliance by issuing the CE marking certificate.

Step 5: Register your company and product on EUDAMED
Under the MDR, all manufacturers must register in EUDAMED, the European database on medical devices, which centralises information on economic operators, devices and post-market surveillance. EUDAMED is designed to improve transparency and traceability on the European market.

• You and your Authorised Representative must register in the economic operators module.
• Each device must be registered in the UDI/device registration module, ensuring compliance with article 27 of the MDR on traceability.

Conclusion

For a US SaMD company, entering the European market requires strict adherence to MDR 2017/745.

Key steps include:

• Setting up a QMS compliant with ISO 13485.
• Classifying the SaMD under the MDR.
• Preparing complete technical documentation.
• Obtaining CE certification (if necessary).
• Registering in EUDAMED.

With the right regulatory approach, your software can successfully enter the European market.