Certification under EU Regulation 2017/745: Medical Equipment (MDR)

EU Regulation 2017/745 (MDR) sets the rules for placing medical devices on the European Union market: from determining intended purpose and risk class to technical documentation, clinical evidence, and post-market surveillance. For the manufacturer, this means that the project must be built as a single system: the requirements, evidence, and documents must be aligned with one another and correspond to the selected conformity assessment procedure.

We support MDR projects for access to the EU market: we help determine applicability and risk class, choose the conformity assessment route, prepare the technical documentation and clinical evaluation, and set up post-market surveillance. In our work, we emphasize verifiability and consistency of the materials so that the package can withstand questions from the Notified Body, audits, and subsequent market control.

What MDR is and why it is needed

MDR is the core EU regulation for medical devices, which has strengthened the requirements for evidence of safety and performance, supply chain transparency, and post-market surveillance. The main practical idea of MDR is simple: the device must be traceable, the risks must be controlled, and the claimed properties must be supported by data.

MDR is important for business because CE marking under it is the main “passport” to the EU market. An error in intended purpose, class, marking, or the composition of the evidence leads to reworking the documentation, additional questions from the Notified Body, and delays in launching sales.

Link to download the Regulation:
Regulation (EU) 2017/745 – Medical Devices (MDR)

Which products fall under MDR

MDR covers medical devices and their accessories, as well as certain software products if the software function is claimed as a medical purpose (for example, diagnostics, monitoring, therapeutic decisions). A separate area of attention is borderline products: sometimes classification depends not on the appearance of the product, but on the wording of the intended purpose, the conditions of use, and the logic of risks.

What most often requires precise qualification

Software as a device
Status depends on the medical purpose and its influence on physician/patient decisions.

Accessories and ancillary items
The contribution to the safety and function of the device is assessed.

Sterile supplies
Separate requirements for control and evidence.

Measurement functions
Substantiation of metrological characteristics and control is important.

Implantable devices
Higher expectations for clinical evidence and surveillance.

CE marking under MDR: the logic of the steps

An MDR project is easier to manage if it is divided into stages. Timelines and scope of work depend on the readiness of the source materials, the risk class, the availability of clinical data, and the selected route. Therefore, at the start it is important to conduct an assessment to understand what already exists, what is missing, and which documents “tie” the whole package together.

MDR technical documentation: what is usually included in the technical file (Annex II/III)

Technical documentation under MDR is structured so that it can be used to verify what kind of device it is, what risks exist, how they are controlled, how the characteristics are confirmed, and how safety is ensured in real use. Consistency is important: the same intended purpose and the same device versions – these parameters must match in the description, clinical documentation, marking, and reporting.

It is also important to define the “boundaries” of the device in advance: configurations, scope of supply, accessories, software versions, packaging options, and sterility. A mismatch between the configuration in the documentation and the actual supply is one of the common sources of questions.

Notified Body: when it is required and what it checks

The involvement of a Notified Body is determined by the risk class of the medical device and the chosen conformity assessment procedure. For most medium- and high-risk devices, it is the Notified Body that performs the key review: it assesses the technical documentation, the quality management system (if it is part of the route), and the extent to which the evidence of safety and performance corresponds to the device’s intended purpose.

To get through the assessment without prolonged clarifications, it is important to prepare not only the documentation package but also an internal “map of responsibility”: who manages each section, where the primary data sources are located, how a single device version is ensured across all materials, and how the post-market surveillance processes are built. The Notified Body pays particular attention to the consistency of the technical file, the correctness of classification and route, confirmation of the claimed characteristics, and the manufacturer’s readiness to maintain conformity after the device is placed on the market.

Where problems most often arise in MDR projects

Difficulties usually arise where there are inconsistencies: different wording of intended purpose, different device versions, different lists of components, mismatch between marking and technical documentation. The second group of problems is clinical evidence: when there is insufficient data specifically for the claimed properties or when equivalence is used without robust substantiation.

The third risk area is post-market surveillance. If PMS is not designed in advance, it “catches up” with the project only after the device reaches the market, when corrections become more expensive: updates to instructions, revision of risks, adjustments to processes, and repeat assessments.

How we support MDR projects

We begin with an assessment: we determine MDR applicability, define the intended purpose and boundaries of the device, check the source materials, and propose a clear work plan. Then we build the conformity assessment route and assemble the evidence package: technical documentation (Annex II/III), risk management, clinical evaluation, and documents for post-market surveillance.

If a Notified Body is required for your risk class, we prepare the package for review in advance: eliminate inconsistencies, align the structure of the materials, and support communication on questions and comments so that the project moves according to plan.