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Regulation MDR 2017/745
Regulation MDR 2017/745 is a regulation of the European Parliament and of the Council on medical devices that came into force on 26 May 2017. It aims to ensure a high level of health and safety for users and patients and to harmonise the regulation of medical devices across the European Union.Key requirements of MDR 2017/745
The key requirements of MDR 2017/745 are to ensure the safety and effectiveness of medical devices in the European Union. These requirements include classification of medical devices, conformity assessment, the role of Notified Bodies, preparation of technical documentation, Post-market Surveillance (PMS) and improved identification of devices on the market.Classification of medical devices
The classification of medical devices according to MDR 2017/745 is based on the level of risk the device poses to the patient. Devices are classified into one of four classes: class I, IIa, IIb and III. Class I devices are low-risk products, such as bandages or wheelchairs. Class IIa covers medium-risk products, such as headphones or contact lenses. Class IIb covers higher-risk products, such as respirators and dialysis machines. Class III are the highest risk products, including implants and stents. Classification is key, as it affects how the conformity assessment of a device is carried out.Conformity assessment
Conformity assessment of medical devices is the process of verifying that the requirements of MDR 2017/745 for a device have been met. Conformity assessment differs depending on their classification. For Class I devices, the manufacturer can carry out the conformity assessment itself and draw up a declaration of conformity. For Class IIa, IIb and III devices, the involvement of a notified body is necessary. For Class IIa devices, the notified body assesses the technical documentation and the manufacturing process. For Class IIb devices, the notified body carries out design and manufacturing verification, while for Class III devices, detailed clinical assessments, technical documentation and factory audits are required.Technical Documentation
The technical dossier includes risk analysis, clinical data and evidence of compliance with MDR requirements. The technical documentation is central to the conformity assessment process and should include a description of the device, its use, risk analysis, countermeasures, clinical data and a description of the manufacturing process and quality control. For example, for a medical implant, the documentation should include the results of biocompatibility tests, clinical trial data and a detailed description of the manufacturing process.Post-market Surveillance (PMS)
Post-market Surveillance (PMS) is the process of continuous monitoring of medical devices after they have been placed on the market. The manufacturer must collect data on the safety and efficacy of devices and analyse incidents and adverse events. PMS includes regular reviews of data from the use of the device, updating the risk assessment and implementing countermeasures. For example, a manufacturer of ultrasound therapy equipment may conduct user surveys and monitor incident reports related to the use of the device to ensure its safety and effectiveness.Identification and traceability of medical devices
Identification and traceability means that each medical device must have a unique identification code (UDI) that enables it to be tracked throughout the supply chain. The UDI helps to identify the device, track production batches and manage potential recalls. The UDI consists of a unique product identification number, manufacturer information and batch or production lot data. For example, a UDI code sticker on the packaging of a medical device allows the product to be quickly identified in the event of an incident report. These key requirements of MDR 2017/745 aim to ensure that medical devices in the European Union are safe, effective and comply with the highest quality standards.The certification process for medical devices under MDR 2017/745
The certification process for medical devices according to MDR 2017/745 requires precise preparation and coordination between the manufacturer and the notified body. The following is a detailed description of the process. The certification process starts with an application by the manufacturer of the medical device to the notified body. Together with the application, the manufacturer should provide a complete technical dossier for the device, which contains all the information necessary to demonstrate compliance with the requirements of MDR 2017/745. The technical dossier should be prepared in accordance with MDR requirements and MDCG guidelines. The notified body starts the assessment process with a detailed verification of the technical documentation provided. The purpose of this verification is to confirm that the documentation is complete and complies with the requirements of MDR 2017/745. The notified body analyses, among other things:- The description of the product, the intended use,
- The risk analysis methodology used and the preventive measures implemented,
- Preclinical and clinical data, including the results of clinical and laboratory studies,
- Quality management system, including procedures for design, manufacture, quality control,
- Fulfilment of the general safety and performance requirements.
