The European Medical Device Regulation (EU MDR 2017/745) which came into force on May 26, 2021, has significantly reshaped the regulatory landscape for medical devices.
The regulations concerning the safety of dental materials were initiated in 1970s in the United States and were classified as medical devices. It was later adopted by the EU in 1993 under the Medical Device Directive (MDD) and revised in 2017 with the introduction of the MDR.
For dental professionals, manufacturers, and distributors, the MDR has introduced new challenges in terms of compliance, certification processes, and documentation. Understanding these regulations is crucial to ensure that dental devices meet the high standards required in the EU market, safeguarding patient health and promoting innovation in dental care.
The classification is determined by the intended purpose of the device, its duration of use, and its level of invasiveness.
Class I: They are low risk devices and do not require a notified body’s involvement for conformity assessment except for sterile devices or those with a measuring function.
Examples of such devices include tweezers, mirrors which are handheld used in diagnosis and surgery, scalpels, examination gloves, impression materials, reusable surgical instruments- scalpel and scalpel handle, reamer, drill bit, dental osteotomes, removable dental prosthesis, dental curing lights, patient dental chair etc.
Class IIa: They are low-medium risk devices and requires more comprehensive assessment to ensure safety and effectiveness, requires certification from a notified body for compliance.
Examples of such devices include, needles or syringes, single use scalpel and blade, needles used for suturing, orthodontic wires, fixed dental prosthesis, fissure sealants, dental aspirator tips, surgical swab, surgical gloves, temporary filling material, chisel, pulp testers, digital x-ray detectors for recording images, x-ray films, etc.
Class IIb: They are medium to high-risk devices and requires more rigorous testing and clinical evaluation. Examples of such devices include non-absorbable sutures, non-biodegradable bone cements, maxillo-facial implants bridges and crowns, dental filling materials, pins, dental alloys, ceramics and polymers, surgical lasers, diagnostic x-ray machine, denture disinfecting products, bone fixation screws/plates with a strongly bound nano-coating, dental implants and abutments.
Class III: They are high-risk devices and requires extensive clinical data to demonstrate safety and efficacy. Examples of such devices include absorbable sutures, biodegradable bone cements, bone fillers with nano materials, bone cements with antibiotics, endodontic materials with antibiotics and animal derived bone graft substitutes.
The European database on medical devices (EUDAMED) is a new key element of the MDR to collect and process information about the devices on the market. This openly available information comprises data on certification, clinical investigation, notified bodies, vigilance and market surveillance.
For dental devices, it includes unique device identifiers (UDI) to ensure traceability and identification of devices such as dental implants, bone grafts, and other implantable devices. Dental professionals are required to maintain accurate records of UDIs for the devices used by them, enhancing traceability and safety.
EUDAMED provides an easier access to device data for the dentist and the patient and could lead to a more educated treatment planning or outcome, while it could also lead to more documentation work for the dentist in the form of storing information on devices which were used during the treatment.
According to the MDR, manufacturers of implantable device, such as dental implants, are required to provide a patient with an implant card as per Article 18 of EU MDR. This contains information about the implantable device, and it is required for a device which is intended to remain in the body after insertion. Dental crowns and fillings are excluded from this requirement as they are not considered as implantable devices.
For implantable devices like dental implants, abutments and bone substitutes, manufacturers also have to submit a Summary of Safety and Clinical Performance (SSCP) according to the Article 32 of EU MDR. It is a summary of device information, previous generations, therapeutic alternatives, and clinical evaluations written in an understandable manner for patients. It allows dentists to make informed material choices without extensive research, especially for CE Marked and compliant devices.
The devices incorporating nanomaterials have been classified based on the concept of internal exposure with high or medium potential as Class III, low potential as Class IIb, negligible potential as Class IIa under Rule 19 as per Annex VIII of EU MDR.
According to the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) possible risk of using nanomaterials for medical devices is mainly attributed to the release of free nanoparticles from the device and the exposure time. In dentistry, some examples are nanomaterial in dental fillings, cements and pastes, nanomaterial filled bone fillers, nanomaterial coating on dental implants etc.
Manufacturers and practitioners need to keep themselves updated about the changing research in nanotechnology and its use in dentistry to comply with the regulation.
Under the MDR, private or white-label manufacturing—where a single dental product is sold under multiple brand names—will no longer be allowed. Previously, CE-marked product manufacturers could provide products to private label companies with limited access to the technical file. However, under the MDR the private label manufacturers must either have access to the technical file or identify the original equipment manufacturer (OEM) on the label.
This change could benefit dentists by making it easier for the identification of products having the same composition sold under different brands, thereby enabling more rational buying decisions based on cost or usefulness and not the brand. It might promote better transparency in product comparisons in dental research.
The MDR is transforming the landscape for dental researchers, especially those in materials science. Previously researchers had access to industry funding and opportunities in Research and Development (R&D). But, under the MDR, manufacturers are required to conduct thorough evaluations of new dental technologies, potentially leading to shift in focus within companies from R&D to regulatory departments.
The clinical evaluation of the device has a greater role to play in conformity assessment procedure. Manufacturers are now required to provide sufficient clinical data to support their devices and claims. This change could be demanding, simultaneously it can provide new opportunities for dental researchers to collaborate with manufacturers on clinical studies.
The limited number of available notified bodies and the complexity of regulatory procedures have made it difficult for manufacturers to obtain the CE marking. The increase in the cost for manufactures is eventually transferred to the end users, including the dentists, which ultimately results in fewer options for the dentists and face higher price for CE marked devices.
The dependability of the smaller dental practices on non-CE marked devices, end up compromising with the device quality and patient safety.
Conclusion
It is well known the significance of EU MDR in ensuring the quality of devices, and their effectiveness and safety, in medical as well as dentistry. The implementation of EU MDR introduces substantial changes, emphasizing the stringent post-market surveillance, enhanced product traceability and also increased scrutiny during the approval process.
Fine-tuning with the evolving regulations is very much needed for dental professionals and manufacturers to continue access to the EU market, protect the patient outcome as well as to support the wider goals of the EU MDR in promoting health and safety throughout all medical fields.
Dr Shrinidhi Ballal, MDS
Jr. Consultant