What does MDR represent? In previous articles and publications, we have presented what MDR (Medical Device Regulation) entails. Today, we have summarized the most important aspects of the updated regulation for those who may have missed reading it. As promised, we have focused on one of the points in the regulation, namely “Risk Management.”

What does MDR represent?

As we have already discussed in previous articles, the Medical Device Regulation (MDR) concerns medical devices and addresses their safety and fundamental provisions regarding their control and risk management during their manufacture. The new regulation replaces the existing Medical Device Directive (MDD) and came into effect on May 26, 2021, following a transitional period of four years (since 2017), which was extended by one year due to the Covid pandemic.

What are the aims of the new regulation?

The objectives of this regulation are to achieve a high level of protection for the health of patients and consumers and to ensure the smooth functioning of the internal market for medical device products. The regulations establish a more robust conformity assessment system to guarantee the quality, safety, and effectiveness of products placed on the market within the territory of the European Union.

How does the Medical Device Regulation (MDR) impact dental laboratories?

Many laboratory owners and dentists with associated laboratories are not aware of how the MDR will affect the dental industry. What changes are there for dental laboratories? What do you need to do to meet all the MDR requirements? The main changes are in risk management and quality.

According to the MDR, both commercial dental laboratories and dentists with in-house laboratories or production are considered “medical device manufacturers.” Therefore, a risk management system or quality management system is mandatory for both dental laboratories and in-house laboratories. Documentation or evidence (traceability) of the used products must be available.

What needs to be entered?

The dental laboratories that have adapted their processes to the DIN EN ISO 13485 standard (2016 version) generally already operate to a large extent in accordance with the Medical Device Regulation (MDR). However, there are some important changes that can be addressed by implementing the necessary software and/or work protocols.

The main elements that dental laboratories need to introduce (if they haven’t already) are:
  • Risk management system
  • Incident reporting and product monitoring system
  • Appointment of a “person responsible for regulatory compliance” under Article 15 of the MDR
  • Adapted Declaration of Conformity according to MDR
  • Batch traceability – tracking of manufactured products and materials used for them
What is “Risk Control”?

Risk control is a measure outlined in the European Union Medical Device Regulation (EU MDR) 2017/745 aimed at minimizing the hazards associated with the use of a specific medical device. Risk analysis for each device becomes part of its production process. Medical device manufacturers, including dental technicians, are required to have a documented risk management plan, identify and analyze hazards, assess risks, and then eliminate or control them.

According to Annex I, Chapter I of the Regulation, manufacturers must manage risks in such a way that it is concluded that any residual risk associated with individual hazards, as well as the overall residual risk, is acceptable. Medical device manufacturers must inform users about residual risks. The following should be implemented:

  • Eliminating or reducing risks as much as possible through safe design and production.
  • Taking appropriate precautionary measures, including the use of warning signals, when necessary, regarding risks that cannot be eliminated
  • Providing safety information (warnings/precautions/contraindications) and, if appropriate, providing training to users.

According to Chapter I, Article 2, residual risks that users and/or other individuals need to be informed about should be included in the information provided by the manufacturer in the form of limitations, contraindications, precautionary measures, or warnings. “Risk” means the combination of the probability of harm occurring and the severity of that harm.

In addressing the elimination or reduction of risks associated with user error, the manufacturer must minimize, to the greatest extent possible, the risks related to the ergonomic characteristics of the product and the environment in which it is intended to be used. The manufacturer must also assess the technical knowledge, experience, education, training, and, where applicable, the environment in which the product is used, as well as the health and physical condition of the intended users.

Risk management according to MDR involves a comprehensive approach to ensure the safety of medical devices and to minimize potential risks to users and others involved.

Risk Management according to MDR

MDR introduces new requirements for risk management, batch tracing, and documentation in dental laboratories. According to Chapter II, Article 10 of Regulation (EU) 2017/745, manufacturers of medical devices establish, apply, document, and maintain a risk management system. It should be noted that risk management is a continuous process throughout the entire lifecycle of the device, requiring regular and systematic updates. In this regard, there are several steps that medical device manufacturers must fulfill, namely:

  • Create and document a risk management plan for each device
  • Identify and analyze known and foreseeable hazards associated with each device
  • Assess and evaluate the risks associated with the intended use and reasonably foreseeable misuse
  • Eliminate or control the risks
  • Evaluate the impact of information from the production stage, particularly from post-market surveillance, on the hazards and their occurrence frequency, on the assessment of associated risks, as well as on overall risk, risk-benefit ratio, and risk acceptability
Additional rules for reducing patient risk

The rules are included in Appendix I, Chapter I of the Regulation, and include:

  • The characteristics and performance of the device should not be adversely affected when the device is subjected to stresses that are not excluded under normal conditions of use and when properly maintained in accordance with the manufacturer’s instructions, to an extent that could compromise the health or safety of the patient, user, or, where applicable, other persons during the specified lifespan.
  • Devices are designed, manufactured, and packaged in a way that their characteristics and performance during the intended use are not adversely affected during transportation and storage, for example, during temperature and humidity variations, when the instructions and information provided by the manufacturer are taken into account.
  • All known and foreseeable risks and any undesirable side effects are limited to the greatest extent possible and are acceptable when assessed in relation to quantitatively defined benefits for the patient and/or user resulting from the device’s performance under normal conditions of use.
Classes of dental products according to MDR

MDR significantly expands the definitions in the field of medical devices and active implantable medical devices. However, these changes affect dental technology and therefore dental laboratories only in exceptional cases. The classification of risk into Classes I, IIa, IIb, and III remains the same in principle. Therefore, temporary dental devices are still classified as Class I (low risk). Permanent dental prostheses fall into Class IIa (medium risk). Dental implants, on the other hand, fall into Class IIb (high risk).

Classifying as Class III (very high risk) requires in-depth clinical investigations (Currently, there are no products in the dental industry that fall into the “very high risk” classification). The focus here is on questions of clinical benefit and potential risks to the patient. Manufacturers must demonstrate the promise of effectiveness based on clinical studies. Point 39 of the preamble to the Regulation states that patients with implanted devices should be provided with clear and easily accessible basic information that allows them to identify the device, as well as other important information about the device, including any necessary health risk warnings or precautions, such as indications of whether the device is compatible with certain diagnostic devices or scanners for security checks. For implantable devices and Class III devices, manufacturers should summarize the key aspects of the device’s safety and performance and the results of the clinical evaluation in a document that should be made publicly accessible.

Periodic Safety Update Report

Chapter VII, Section 1, Article 86 of the Regulation states that manufacturers of Class IIa, Class IIb, and Class III devices shall prepare a Periodic Safety Update Report (PSUR) for each device and, where applicable, for each category or group of devices, which summarizes the results and conclusions of the analyses of post-market surveillance data collected based on the post-market surveillance plan referred to in Chapter VII, Section 1, Article 84, together with the rationale and description of the preventive and corrective actions taken. Throughout the entire lifetime of the respective device, this PSUR shall include:

  • Conclusions to be used in determining the risk-benefit ratio;
  • Key findings from post-market clinical follow-up (PMCF);
  • Sales volume of the device and an approximate estimate of the number and other characteristics of the population using the device and, when possible, the frequency of use of the device;

Manufacturers of Class IIa devices update the report as necessary and at least once every two years. For custom-made devices, the PSUR is part of the documentation in Part 2 of Annex XIII. Annex XIII describes the procedure for custom-made devices, and we discussed part of the annex in our previous article on the MDR regulation.

Post-Market Surveillance

According to Point 61 of the preamble in the Regulation, “Market surveillance” refers to the activities and measures undertaken by competent authorities to verify and ensure that products comply with the requirements laid down in the relevant Union harmonization legislation and do not present a risk to health, safety, or other aspects related to the protection of public interest.

Points 33 and 34 of the preamble in the Regulation explain that the risk management system should be carefully aligned with the clinical evaluation of the product, including the clinical risks that should be addressed as part of clinical investigations, clinical assessment, and post-market clinical follow-up. Risk management and clinical evaluation processes should be interdependent and regularly updated. It should be ensured that product manufacturing monitoring, post-market surveillance activities, and safety tracking are carried out within the manufacturer’s organizational structure by a person responsible for compliance with regulatory requirements, and meeting minimum qualification conditions.

AMOSYS and Risk Management
Process Tracking

With the AMOSYS software, you can easily track the entire process: from ordering the product to the stages of its production and subsequent placement in the patient’s oral cavity. The system works in “stages,” meaning that each stage of the product’s production is marked as a separate one, and any changes made by the dentist or dental technician are communicated to the other party, ensuring that nothing is overlooked.

Stages and Assigned Dental Technicians

Furthermore, in the laboratory management module, there is an option to assign each stage of the product’s production to a specific dental technician. In other words, knowing that a particular stage takes a minimum specific time, you can easily track whether the dental technician has met all the requirements and whether the product/part of the product complies with all quality and safety standards. You know who worked on what, how much time was spent, and what materials were used. You can add the necessary number of notes, files (including declarations), and multimedia content to each product, all in one place.

All Orders and Multiple Filters

In the event of a defect or any other reason, you may need to search for an old order. Your information is not lost, and everything is there—it can be easily found using filters and traced from the order date to the final stage of product production.

See the benefits of the software for yourself and request a demo at: https://amosys.eu/en/booking/

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