The Medical Devices Directive applies to medical devices, accessories and medical software.
Medical device is defined as instrument, apparatus, appliance, material, software or other article intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of desiases, injuries or disabilities.
Accessory is an item whilst not being medical device is intended by manufacturer to be used together with the medical devices. Care products for contact lenses are an example of accessories.
Medical software is included in the definition of medical device. The official guideline of the European Commission (MEDDEV 2.1/6) describes medical softwareas: “Software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”.
Medical devices must comply with essential health and safety requirements and must bear the CE marking. The applicable requirements vary depending on the classification of medical devices. Medical devices are divided into the following classes:
The classification of medical devices is made in accordance with the Directive and Guidelines MEDDEV 2.4/1. Depends on the classification of medical device the conformity procedure varies.
By affixing the CE marking on medical device the manufacturer and/or importer declare that the product comply with an essential requirements of the Medical Devices Directive 93/42/EEC. CE marked medical devices can be traded freely within EEA-area.
The Medical Devices Directive does not apply to:
Certification Company accompanies comple CE marking for medical devices in accordance with the Medical Devices Directive 93/42/EEC. In addition to complete CE certification you can contact us for the following services:
The Medical Devices Directive 93/42/EEC contains the legal obligations for each type of economic operators (manufacturer, importer, distributor). The following step-by-step plan has been drawn up for the manufacturer.
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Please visit our Library to read more about Medical Device Directives.
The cost of CE Certification for medical varies by the assessment procedure. Request a quote to understand what your certification will cost.