CE marking is the gateway to the European market for any Digital Medical Device. Here is the path to MDR 2017/745 compliance in five clear steps, from classification to EUDAMED registration.
CE marking is the condition for accessing the European market with any Digital Medical Device (SaMD). It attests that your software meets the safety and performance requirements of Regulation (EU) 2017/745 (MDR). Without it, no legal commercialisation is possible in the European Union.
The process may look complex. It actually follows a clear path in five steps. Before going through them, two risks deserve attention, as they explain most projects that go off track.
Poor regulatory scoping. Scoping determines the class of the device and the functionalities to include in the scope of the medical device. It drives far more than compliance: the product roadmap, the commercialisation strategy, potential reimbursement and the cost of CE marking all depend on it directly. A poorly calibrated regulatory strategy costs time and budget, often considerably.
Loss of momentum. Run without dedicated steering, CE marking drags on. Teams move forward without certainty about what they produce, momentum fades and frustration sets in. The answer is to run CE marking as a project in its own right, with clear milestones across the following five steps:
1. Qualify and classify your software
First determine whether your software meets the definition of a medical device, based on its intended purpose. Then identify its risk class (I, IIa, IIb or III) by applying Rule 11 of the MDR and the MDCG 2019-11 guidance. This class determines all of your obligations and the level of scrutiny required.
2. Implement a Quality Management System (QMS)
The QMS, compliant with ISO 13485, governs the design, development and maintenance of the device. It ensures documented, controlled and traceable processes across the entire product life cycle.
3. Build the Technical Documentation
The name is misleading. Despite its title, the Technical Documentation is not limited to technical elements: it also includes the clinical evaluation of the software. It actually gathers all the evidence that the device does what it claims, and does it safely. It covers the product description, the software development life cycle (IEC 62304), risk management (ISO 14971), the clinical evaluation, usability engineering (IEC 62366) and the post-market surveillance plan.
4. Complete the conformity assessment
For Class I, self-certification is sufficient: you attest to compliance yourself. From Class IIa upwards, a Notified Body (NB) audits your QMS and your Technical Documentation before issuing the certificate. Two parameters then weigh on the project: lead times, as NBs are in high demand, and cost, since NB involvement represents a significant expense to budget for from the start.
5. Declare, mark and register
Issue the EU Declaration of Conformity, affix the CE mark, then register your company and your device in EUDAMED. Post-market surveillance then takes over to maintain compliance over time.
CE marking of a Digital Medical Device rests on five steps: qualify and classify, structure quality, document, get assessed, then declare and monitor. The risk class determines the effort required at each step. Solid scoping upfront and running the work in project mode limit rework and secure time to market.
At Sparta Care, we support Digital Medical Device manufacturers with:
Contact us to assess your risk class and define your CE marking strategy.
