MDR Certification

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At Fenaris, we provide accelerated EU Quality Management System Certification leading to MDR CE marking through a fully integrated regulatory and conformity assessment pathway. Working in close coordination with our contractual Notified Body, we are able to structure and execute MDR certification projects with a typical timeline of 8–12 months, while maintaining strict regulatory robustness and offering a cost structure that is significantly lower than most traditional EU consultancy models. The overall certification cost depends on the device type, classification and applicable conformity assessment route, but our MDR certification packages typically range from €40,000 to €70,000, covering the complete process from initial regulatory assessment through successful CE certification.

Notified Body Involvement

Under the EU MDR, the level of Notified Body involvement depends primarily on the classification of the medical device and the applicable conformity assessment route. A Notified Body is an independent organisation designated by an EU Member State to perform third-party conformity assessment where the MDR requires it.

For Class IIa, Class IIb and Class III devices, Notified Body involvement is generally required. Certain Class I devices also require third-party assessment when they are supplied sterile, have a measuring function, or are reusable surgical instruments. Other Class I devices can generally follow a manufacturer-led conformity assessment without Notified Body intervention.

The Notified Body may assess elements such as the manufacturer's quality management system, technical documentation, clinical evidence, risk management and applicable conformity assessment procedures. The exact scope and route depend on the device classification, intended purpose, technology and applicable MDR requirements.

Choosing the correct conformity assessment pathway at the beginning of the MDR process is critical. An incorrect classification or inappropriate assessment strategy can lead to additional documentation, repeated assessments and significant delays in CE certification.

We work in strategic partnership with UDEM Adriatic for MDR certification, enabling us to provide manufacturers with highly competitive certification costs and an efficient, streamlined assessment process. Through this strategic cooperation, we can help reduce unnecessary delays and achieve MDR certification as quickly and cost-effectively as possible.

CE Marking

CE marking is the manufacturer’s formal declaration that a medical device complies with the applicable requirements of Regulation (EU) 2017/745 (MDR) and may be legally placed on the European market. Achieving CE marking is not a single certification step, but the result of a structured conformity assessment process covering several interconnected regulatory elements.

The process begins with technical documentation, which must demonstrate that the device meets the MDR’s applicable General Safety and Performance Requirements. This is supported by clinical evaluation, which establishes the clinical safety and performance of the device, and risk management, which identifies, evaluates and controls risks throughout the product lifecycle.

Manufacturers must also establish and maintain an appropriate Quality Management System (QMS) and implement effective Post-Market Surveillance (PMS) processes to continuously monitor the device after it enters the market. Depending on the device classification and conformity assessment route, Notified Body involvement may also be required.

These elements are interconnected: deficiencies in one area can affect the entire conformity assessment process. We support manufacturers in building a complete, coherent MDR compliance strategy, ensuring that the technical, clinical, quality and post-market requirements work together toward successful CE marking and sustainable European market access.

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