93/42/EEC of the European Union (also known as the Medical Devices Directive – MDD) details the Essential Requirements manufacturers and importers must meet to apply the CE mark and legally market or sell their devices in the EU. Because of the many types of devices covered by the MDD, the specific requirements depend on the classification and intended use of the device. However, in most cases, the use of an EU Notified Body is required to assess compliance with the Directive before the CE mark can be applied to a device.
What are Medical devices?
A medical device is any instrument, apparatus or appliance that is used to diagnose, monitor or treat a disease, injury or handicap in humans. The term “medical device” applies to a broad range of products, devices and equipment, from simple tongue depressors and bedpans to laser surgical devices. Medical devices can also include certain electronic radiation emitting devices with medical applications, including ultrasound devices and x-ray machines.
While the term is broadly applied, medical devices should not be confused with other classes of products used to treat medical conditions. For example, medications and pharmaceutical preparations, which treat medical conditions through chemical action or by being metabolized by the body, are not considered medical devices, and are subject to different regulations and requirements.
What are the regulatory requirements?
A manufacturer must develop technical documentation or design dossiers in order to evaluate the compliance of their device against the essential requirements and establish a quality management system that meets the requirements of the MDD. In addition to legislative documents, manufacturers must also consider guidance documents, consensus statements and interpretative documents under the MDD.
Our services:
- Design dossier and technical documentation
- Quality system auditing
- Testing