Regulation (EU) 2017/745 – also known as the Medical Devices Regulation (MDR) was adopted on May 25, 2017 and thus replaced the Medical Devices Directive 93/42/EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMDD). The Regulation became fully applicable on May 26, 2021, while certain devices may make use of an extended transition period. The principle of CE Marking remains the same! Read here, what is required to obtain the CE Mark for medical devices.
- Classification: Understanding the classification of a medical device is the foundational step. Regulatory bodies categorize devices in Annex VII of MDR based on their risk and intended use, laying the groundwork for the certification process.
- Unique Device Identification (UDI): Assigning UDI to each medical device is crucial. This identifier will improve the traceability of medical devices, enhance post-market safety-related activities and allow for better monitoring by competent authorities. More about UDI is presented in Article 27 of the MDR.
- General Safety and Performance Requirements (GSPR): Compliance with GSPR is the most important component for certification. In Annex I of the MDR, a complete set of requirements is collected with which all medical devices must comply to prove that they are designed and produced to be safe and to fulfil their intended uses. The objective evidence that GSPR requirements are fulfilled are in the technical documentation.
- Technical Documentation: Comprehensive technical documentation serves as the backbone of the certification process. No matter the medical device class, technical documentation must always be available. This dossier includes detailed information about the device’s design, manufacturing, performance, and risk mitigation strategies. Guidelines for the content of the technical documentation provides Annex II of MDR.
- Conformity Assessment: The next step is to check under which conformity assessment route you will certify your medical device. According to the MDR, there are three types of conformity assessment procedures, and the manufacturer may choose which one is best for him. Conformity assessment describes a procedure that determines whether a medical device complies with the requirements in the MDR. It provides proof that the general safety and performance requirements are fulfilled.
- Declaration of Conformity: According to Article 19 of MDR the Declaration of Conformity is a formal statement by the manufacturer affirming that the device complies with all applicable regulations. It is a key document in the certification process.
- Review of the Quality Management System (QMS): A robust QMS is critical for maintaining consistent product quality. Regulatory authorities assess the QMS to ensure that it aligns with the necessary standards. MDR requires all medical device manufacturers to comply with ISO 13485:2016 certification to demonstrate their compliance with essential safety and performance requirements. The main requirements for manufacturer’s QMS are reported in Article 10 of MDR.
- Clinical Evaluation: For any device regardless of class, the manufacturer must ensure the general safety and performance requirements are satisfied. This includes carrying out a clinical evaluation (Article 5 (3) and Article 61 of MDR) with a critical evaluation of the relevant scientific literature (Annex XIV of MDR) or/and with a critical evaluation of the results of all available clinical investigations (ISO 14155:2020 and MDR Annex XV) or a consideration of currently available alternative treatment options for that purpose, if any.
- Post-Market Surveillance: Article 83 outlines the specific requirements for post-market surveillance which requires continuous monitoring after market entry to identify and address any emerging issues.
- Vigilance: According to Article 7-92, vigilance mechanisms are in place to promptly detect and respond to adverse events or safety concerns related to the medical device. This proactive approach enhances patient safety throughout the product’s lifecycle.
- Registration in Eudamed: The creation of a European Database on Medical Devices (EUDAMED) is one of the key aspects of the new rules on medical devices of DR. As stated in Article 33, EUDAMED is IT system developed by European Commission that allows patients and stakeholders to access a large quantity of data and useful information; the goal is to improve overall transparency in the sector as well as to improve coordination of information regarding medical devices available on the EU market.
Embarking on the journey to medical device certification demands a full approach, where each elements described above are connected.
Engaging with regulatory consultants and experts in the field can provide invaluable insights. Collaborating with professionals who specialize in medical device certification ensures the fulfilment of regulatory requirements with a thorough understanding, reducing the risk of compliance pitfalls.