CE marking (Conformité Européenne) is at the heart of the EU’s regulatory approach. This marking indicates that a product complies with EU regulations and can be freely marketed in the EU. Obtaining the CE marking involves a number of steps, including identifying the applicable legislation and harmonised standards, determining the classification, carrying out conformity assessment procedures, preparing technical documentation and drawing up an EU declaration of conformity.
In a complex healthcare structure, medical devices play a key role in diagnosis, treatment and patient care. Notified bodies in the European Union (EU) are at the forefront of ensuring that these devices meet stringent regulatory requirements before they reach the market.
MDR and IVDR Regulations
The European Union has implemented two main regulations for medical devices and in vitro diagnostic medical devices: the Medical Devices Regulation (MDR) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746. Although both aim to increase patient safety and modernise public health, they apply to different types of medical technology and have partially separate regulations.
Certification of medical devices
Rules for certification of medical devices in the European Union are presented in Regulation MDR 2017/745.
Certification of in vitro diagnostic medical devices
Rules for certification of in vitro diagnostic (IVD) medical devices in the European Union is presented in Regulation IVDR 2017/746.
The role of notified bodies
As independent organisations designated by EU Member States, notified bodies play a key role in the certification process. Our responsibilities go far beyond simply filling in forms. It is our job to carry out thorough conformity assessments, issue certificates of conformity, ensure continued compliance through surveillance activities and assess significant changes to certified equipment.
Certification for the MedTech industry
From our perspective as a future notified body, we have observed that manufacturers who engage early in the process, maintain comprehensive documentation, invest in gathering robust clinical evidence and implement thorough post-market surveillance systems tend to move more smoothly through the certification process.
It is crucial for manufacturers to understand that certification is not a one-off event, but an ongoing process. The MDR regulation places considerable emphasis on post-market surveillance. As a notified body, our role goes far beyond the initial certification. We conduct regular surveillance audits, review surveillance reports, assess field safety corrective actions and evaluate periodic safety reports to ensure ongoing compliance and safety.
