Dentistry

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Explore how standards support the provision of high quality dental services and products

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Overcoming barriers: How do standards support product innovation in the dental sector?

Innovation in the dental sector is generally associated with new technology and products that are aimed at providing high-quality care. Artificial intelligence (AI) and machine learning, 3D printing, smart toothbrushes, and teledentistry are just some of the technologies that are emerging in this sector. As with other medical fields, these disruptive innovations will have a huge impact on how dental products will be manufactured and how patients will take care of themselves in the future if barriers to their adoption can be overcome. Innovation vs. Regulation Historically, regulation has rarely sat so comfortably alongside innovation. While most dental organizations respect their industry regulators for the vital functions they perform – not least, squeezing out ‘cowboy’ competitors and sub-standard products – they also tend to regard them as a drag on innovation. That’s because regulators limit manufacturers to doing only what they have approved. Regulators favor narrow, restricted, or ‘regulated’ behaviors and products. As a result, while there will invariably be trusted because they have been tried and tested, they also tend to evolve slowly. The regulators’ goal has been to keep things safe, often by keeping them the same. Conversely, by definition, innovation means finding new ways to operate or solve problems, often by moving first and acting fast. Innovations won’t have been extensively tried, tested, and approved. It adds up to an inevitable tension with regulation. To address so many challenges, dental businesses, such as manufacturers of dental products, need flexible distribution arrangements. Traditionally, they have faced regulatory hurdles, such as only being able to use existing distribution partners that have been tried, tested, audited, and approved. Now, through digital collaboration – the sharing of real-time data to demonstrate safe, high-quality distribution – these manufacturers can be freed to react effectively to the needs of the marketplace. The Key Dentistry Standards that Support Product Innovation Dentistry standards can provide knowledge to dental innovation. They underpin dentistry best practices that allow innovators to accelerate the time-to-market of new products and services, whilst holding them to account for the rules and agreed guidelines that serve the public interest. Innovation standards bring together dental professions with industry and the public to create the potential for improved patient outcomes. They are also critical in the commercialization of new dental technologies, building trust and supporting the creation of new markets at home and internationally. The BS EN ISO 56000 series helps organizations introduce an innovation management system to identify the most important challenges, capture the right ideas, seize the best opportunities and properly manage emerging trends and risks. Companies need to consider not only the benefits of their innovations, but also any possible adverse impacts, including through unintended use, misuse or other unforeseen consequences; and to plan accordingly. Whilst society has never been hungrier for innovation, it has also never been less tolerant of innovation which fails. To help companies innovate responsibly, PAS 440:2020 provides overarching guidance on how to structure innovative thinking and processes responsibly, irrespective of domain. It helps dental companies to think through the wider implications of their innovation, capture the outcomes of their reflection and communicate this to stakeholders and wider society. PAS 440 is particularly relevant in the area of early-stage new dental technologies but can be applied anywhere. Its use helps to identify and mitigate risks – before they become an issue. And it can help organizations to reassure investors, customers, and other stakeholders that the benefits of any innovation can be achieved, with appropriate mitigation of any potential downside risk, wherever that might otherwise accrue. As technology continues to advance rapidly in the dentistry sector, accessing the standards your business needs to adapt to these innovations does not have to be complicated and time-consuming. Our tailored BSI Knowledge subscription service provides flexibility, access, visibility, and control over the standards and insights your team needs to adopt emerging processes. Request to learn more. Ensure your dental business is innovating to best practices by adding these key standards to your collection today.

Meeting regulations for dental devices and implants with dentistry standards

Dental devices are generally characterized as devices intended to treat or reconstruct dental tissue. 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. What are the Key Dental Devices Standards? As a global industry leader, we are committed to sharing best practices by providing easy access to standards. 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. In your compliance-critical industry, ensure you are meeting the industry standards. A BSI Knowledge subscription gives you instant access to the resources you need to improve the safe design, manufacture, and use of dental devices. The flexibility and visibility it provides of the best practices guidance enable you to get the most from your dental equipment standards. Build your own custom collection of standards, or opt for access to over 4,800 documents in our GBM05 Sciences & Healthcare module and keep up-to-date with any relevant changes to your standards strategy. Request to learn more. Ensure your dental implants and devices comply with the latest industry regulations by adding these key standards to your collection today.

Key Dentistry Standards

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