The scope of dental devices ranges from the lowest risk and classification (such as reusable instruments) to the highest risks and classification - for example total joint replacements, resorbable devices, orthobiologics, device/drug combination devices - just to mention a few.
Their use is increasing throughout the world. Due to improved and new applications of dental devices and implants, the need for better instruments and related accessories to be used in their placement and the further manipulation of connecting parts in the craniofacial area is also growing.
Dental devices and implants are subject to strict regulatory approval. Regulatory requirements and compliance for dental devices are covered under the Medical Devices Regulation (EU) 2017/745.
There are several key standards that can help manufacturers and suppliers ensure this compliance is achieved.
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There are three levels of standards dealing with medical devices used in dentistry, though there is no level 1 standards written exclusively in respect of medical devices used in dentistry.
These levels are as follows:
Level 1: General requirements for medical devices
Level 2: Requirements for families of medical devices used in dentistry
Level 3: Specific requirements for types of medical devices used in dentistry
Some of the key standards for dental devices and implants are as follows:
BS EN ISO 13485:2016+A11:2021 Medical devices. Quality management systems. Requirements for regulatory purposes
BS EN ISO 13485:2016+A11:2021 is the international standard that sets out regulatory requirements for medical device quality management systems. It provides the basis for ensuring consistent design, development, production, installation, and delivery of products that are safe for their intended purpose. It also harmonizes global requirements and is recognized by regulators in many jurisdictions around the world.
To find out more about the importance of this standard, and how to implement it effectively, click here.
BS EN ISO 20417:2021 Medical devices. Information to be supplied by the manufacturer
BS EN ISO 20417:2021 details the information that medical device manufacturers should supply with their products. It specifies the information to be supplied by medical device or medical device accessory manufacturers. It covers general requirements, medical device identification, requirements for packaging, requirements for marking and information on the label, and requirements for accompanying documentation.
BS EN ISO 14971:2019+A11:2021 Medical devices. Application of risk management to medical devices
Recognized by regulatory authorities in the US, Canada, Europe, and more, BS EN ISO 14971:2019+A11:2021 specifies terminology, principles, and a process for medical devices risk management, including software as a medical device and in vitro diagnostic medical devices. It helps medical device manufacturers establish, document, and maintain a systematic risk management process across all phases of the lifecycle of a medical device. The use of the standard helps streamline the regulatory processes that enable entry to selected markets.
BS EN 1639:2009 Dentistry. Medical devices for dentistry. Instruments
BS EN 1639:2009 specifies general requirements for instruments used in the practice of dentistry and which are medical devices. With regards to safety, it includes requirements for intended performance, design attributes, components, reprocessing, packaging, marking, labeling, and information supplied by the manufacturer.
BS EN 1640:2009 Dentistry. Medical devices for dentistry. Equipment
BS EN 1640:2009 specifies general requirements for dental equipment used in the practice of dentistry and which are medical devices. With regards to safety, it includes requirements for intended performance, design attributes, components, packaging, marking, labeling, and information supplied by the manufacturers.
BS EN 1641:2009 Dentistry. Medical devices for dentistry. Materials
BS EN 1641:2009 specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function of the dentition and which are medical devices. For the purposes of this standard, these materials are defined as restorative and orthodontic materials. With regards to safety, it also includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labeling, and information supplied by the manufacturer.
BS EN 1642:2011 Dentistry. Medical devices for dentistry. Dental implants
BS EN 1642:2011 specifies general requirements for dental implants and accessories. With regards to safety, it includes requirements for intended performance, design attributes, components, packaging, marking, labeling, and information supplied by the manufacturer.
BS EN ISO 13504:2012 Dentistry. General requirements for instruments and related accessories used in dental implant placement and treatment
BS EN ISO 13504:2012 specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants and further manipulations of connecting parts in the craniofacial area. It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system.
With regards to safety, it also gives requirements for classification, intended performance, performance attributes, material selection, performance evaluation, manufacture, sterilization, and information to be supplied by the manufacturer.
All the above standards contribute to achieving UN Sustainable Development Goal 3 of ensuring healthy lives and promoting well-being for all of all ages. This goal looks for the provision of quality healthcare, and of equipment that helps healthcare providers deliver a safe, reliable, and effective service, which is what these standards support.
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Ensure your dental implants and devices comply with the latest industry regulations by adding these key standards to your collection today.