Medical Devices regulatory services: MDR & IVDR compliance and CE marking

The Medical Devices Regulation (MDR – EU 2017/745) applies to general medical devices, while the In Vitro Diagnostic Regulation (IVDR – EU 2017/746) focuses on diagnostic devices such as reagents and tests used to examine human samples. Both regulations reinforce safety, clinical evidence and post-market surveillance requirements, but the IVDR introduces a more stringent classification system for diagnostics and closer involvement of Notified Bodies. CEHTRA supports companies in identifying the applicable framework and ensuring compliance with both MDR and IVDR obligations.

CE marking demonstrates that a device complies with EU regulatory requirements and can be legally placed on the market. Preparation involves:

• Defining the intended use and classification of the device.

• Establishing a Quality Management System (QMS) compliant with ISO 13485.

• Conducting a biological safety and risk assessment (ISO 10993).

• Preparing the technical documentation including performance and safety data.

• Submitting the dossier to a Notified Body (when required).

CEHTRA assists manufacturers throughout this process by providing regulatory strategy, dossier preparation, and expert responses to Notified Body questions.

A Clinical Evaluation Report (CER) is a mandatory document under MDR that demonstrates the clinical safety and performance of a medical device. It compiles and assesses data from clinical investigations, scientific literature, and post-market experience. CERs are crucial because they provide the evidence required by Notified Bodies to grant CE marking and must be regularly updated throughout the device’s lifecycle. CEHTRA’s consultants support manufacturers in writing and maintaining CERs to ensure robust documentation and smooth regulatory approval.