CE mark for medical devices

New Medical Devices Regulation (MDR) for greater safety in daily hospital routine

As the transition period comes to an end and the new Medical Devices Regulation (MDR) for medical devices comes into effect, the manufacturers of medical devices face tougher requirements. They must now provide evidence and documentation showing that their products work safely and reliably throughout the product life cycle. This is intended to increase patient safety.

In the medical environment, the CE mark stands for high product quality and unrestricted patient safety. It is visibly present on many products used in the clinical setting, such as masks, syringes, and medical ventilators. In order to maintain the high standard, manufacturers of CE-marked products must comply with numerous regulatory requirements.

To strive for optimal product safety and to improve the already high level of patient safety, the Medical Device Regulation (MDR) will come into force on May 26, 2021 with far-reaching changes and more stringent requirements for manufacturers of CE-marked medical products. The Medical Device Regulation is a legally binding European regulation (EU 2017/745) and replaces the Medical Device Directive (MDD) after a 4-year transition period.

The aim of the MDR is to increase patient safety and the high-quality requirements for the development and manufacture of medical devices, to ensure the monitoring and traceability of medical product over the entire life cycle. It places new and extensive requirements on the content of the technical documentation and calls for the introduction of a new labeling system. The UDI system (Unique Device Identification) enables medical devices to be clearly assigned and registered in a central European database for medical devices (EUDAMED).

Medical device manufacturers face strict requirements
Point-of-use sterile filters are normally used in hospitals to prevent infection and, as a result, they also play an important role in the current pandemic situation. Manufacturers who make their corresponding products recognizable as medical devices with the CE mark must meet many different requirements in order to guarantee that patients are protected. These requirements relate to such factors as risk analysis and risk evaluation, technical documentation, lifecycle management and biocompatibility testing.

To ensure that a product fulfils the criteria for the CE mark, the manufacturer goes through what is known as a conformity assessment procedure. In the first step of this procedure, the manufacturer has to check whether the product conforms to the definition of a medical device and whether it is intended to fulfil a medical function. In the second step, evidence from clinical studies must be provided. The evidence in support of point-of-use sterile filters, whose intended purpose is to prevent infection, has been confirmed in numerous clinical studies.

Biocompatibility testing guarantees patient safety
When the clinical usefulness of the medical device has been demonstrated, it must be shown in the next step whether the manufacturer has a quality management system in place that has been certified in accordance with DIN EN ISO 13485:2016. This standard proves that the manufacturer acts in accordance with the legal requirements in the development, manufacture and monitoring of medical devices.

Furthermore, the manufacturer has to guarantee on the basis of legal product requirements that extensive technical and clinical documentation is provided for the product and especially that the product is biologically compatible and does not contain substances which could harm the patient. This is established with the so-called standard biocompatibility test described in ISO 10993. Point-of use sterile filters are also subjected to this test because they have indirect contact with patients via the filtered water.

For a declaration of conformity and authorization as a CE-marked medical device, all these strict legal specifications must be met. In the current situation, especially, CE marking of medical devices for infection prevention provides important verification that their use is safe for patients, users and third parties.

Medical devices in hospital routine
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