MDR and UKCA Services for Dental Medical Devices

Dental devices cover a broad spectrum, ranging from implants and instruments to fillers and impression materials. To ensure that the EU Notified Body or UK Approved Body is qualified to review a specific device, devices are categorized and grouped based on the intended use or technologies employed in the device. For the convenience of the manufacturer, we use a single coding system for both the EU and the UK. The devices are allocated codes based on the publicly accessible MDR code list from commission implementation regulation (EU) 2017/2185 of Nov 23, 2017. This is further explained by the Medical Device Coordination Group Document MDCG 2019-14 to identify and categorize dental devices. These may include:

• MDN 1103: non-active dental implants and dental materials, covering devices like dental implants, dental fillers, and permanent root canal guta percha fillers, abutments, dental crowns, veneers and composite resins, among others
• MDN 1202: non-implantable devices designed for the administration, channeling, and removal of substances. It covers items such as the non-active components of suction devices or saliva ejectors, among others
• MDN 1208: this category encompasses non-active, non-implantable instruments such as dental scalers, mirrors, excavators, burnishers and curettes
• MDN 1209: non-active, non-implantable dental materials, such as etching solutions, braces, short-term cements, and impression materials, among others

To support efficient conformity assessments, devices are also grouped using the European Medical Device Nomenclature (EMDN) for the EU, or the Global Medical Device Nomenclature (GMDN) in the UK, to identify and categorize dental devices that can be assessed together.

Under the EU and the UK regulations, medical devices are classified into classes I, IIa, IIb, and III, based on their intended purpose and inherent risks. The classification of a dental medical device may be determined by the application of one or more of the classification rules outlined in these individual regulations. For CE marking, classification rules are listed in Annex VIII of the EU MDR and the UKCA Classification rules are listed in Annex IX of the UK MDR. This can lead to slight differences in the classification in the EU and the UK.

Under the EU MDR, rules 4, 5, 6, 8, 18, and 19 are most relevant to dental medical devices. For example:

• Dental wound dressings not containing animal derived material are classified as Class IIa under Rule 4
• Handheld mirrors used in dentistry and dental impression materials are Class I under Rule 5
• Orthodontic wires are Class IIa under Rule 5
• Reusable dental osteotomes are Class I under Rule 6
• Dental filling materials are Class IIa under Rule 8
• Dental implants and abutments are Class IIb under Rule 8
• Periodontal and collagen membranes sourced from bovine or porcine tissues are class III by Rule 18
• Dental filling materials incorporating or consisting of nanomaterial can be class IIa, IIb, or III, depending on the level of internal exposure to nanomaterial, as per Rule 19

Generally low-risk Class I devices are ‘self declared’ by the manufacturer. However a Notified Body and/or UK Approved Body needs to be involved in the assessment of dental Class I devices that are sterile, or have a measuring function. Under the EU MDR, Class I reusable devices also require Notified Body involvement and there are specific conformity assessment requirements for class IIb devices that are implantable.

The EU MDR introduces the concept of ‘well-established technologies’ (WET) where specific requirements of the regulations may not apply to an exempt list of devices, including dental fillings, dental braces, and tooth crowns. This can reduce the conformity assessment activities required for well-established devices, so it is important to be aware of the latest interpretation of ‘well-established’ and the list of exemptions.