The regulatory strategy is the first and extremely important element of the medical device design process, which initiates the activities necessary to define the project schedule and leads through the device development process until implementation. The regulatory strategy is a detailed medical device design plan and implementation scheme defined based on regulatory and normative requirements for a specific medical device. Careful preparation of the regulatory strategy greatly facilitates the implementation process and helps draw attention to possible errors, problems or risks in advance. The regulatory strategy includes all the activities necessary to be carried out at the design stage from determining the qualification and classification of the device, through the selection of appropriate tests and requirements for the device, the development of a clinical development strategy to the determination of the necessary documentation and obligations that the manufacturer should meet to implement the medical device on the market. The regulatory strategy is a basic tool for planning activities, tracking regulatory changes and identifying risks that occur during the design stage of a medical device.
Design process of a medical device
When starting work on the design of a medical device and regulatory strategy, it is important at the outset to consider the organization’s business model, check the demand for the device in the market, and consequently consider the audience by conducting a literature review and analyzing competing devices in the market.
Qualification and Classification
The first and one of the most important elements of the regulatory strategy is the proper qualification and classification of the medical device. The qualification of a medical device is based on the definition in Regulation 2017/745, and the rules for classification are described in Annex VIII of the regulation. The division into classes of a medical device is made based on the intended use and description of the device’s function, composition, indications, time and place of contact of the device with the body.
Due to recent legal changes and the introduction of the new Regulation 2017/745, determining the correct class of medical device is a major challenge for manufacturers. The regulations on device classification are often ambiguous and provide wide room for interpretation. In addition, not all devices that were medical devices under the requirements of the Directive remain in this status under the new requirements. Manufacturers of devices consisting of substances or mixtures of substances that are absorbed by the human body or locally dispersed in the body, as well as manufacturers of devices that do not have a medical use subject to Annex XVI of MDR Regulation 2017/745, should pay particular attention to making the appropriate qualification and classification of the device.
Adequate determination of the class of the device is therefore a key stage that influences all subsequent activities included in the regulatory strategy – it allows the selection of an appropriate conformity assessment procedure and the requirements that the device must meet, as well as the selection of appropriate testing and clinical strategy.
Legal and normative requirements for the medical device
The basis for appropriate implementation of a medical device, but also for drawing up a regulatory strategy, are the current legal and normative requirements for the device. In the field of medical devices, the Regulation of the European Parliament and of the Council (EU) 2017/745 applies, as well as the Law of April 7, 2022. In addition, detailed requirements for medical devices are contained in ISO standards, as well as the MDCG Medical Devices Coordination Group guidelines available on the European Commission website. Confirmation of compliance with regulatory and normative requirements is a declaration of conformity issued by the medical device manufacturer.
Conformity assessment procedure
The next step in the regulatory strategy is to determine the appropriate conformity assessment procedure for the medical device. The conformity assessment procedure is determined in accordance with Regulation 2017/745 based on the risk class of the device. At this stage, it is crucial to determine whether the procedure will involve a Notified Body or whether the manufacturer itself will assess and declare compliance with the requirements for its device. Conformity assessment is carried out based on the product manufacturer’s quality management system and evaluation of technical documentation.
Identification of applicable general safety and performance requirements
Next, according to Annex I of the MDR Regulation, general safety and performance requirements applicable to a specific medical device must be identified. These requirements include general requirements, design and manufacturing requirements, and requirements for information provided with the device such as instructions for use, label. Proper identification of the requirements allows you to accurately determine the verification and validation tests for the device.
Risk management process
It is also important to plan risk management activities in accordance with ISO 14971, which defines the terminology, principles and processes associated with identifying medical device hazards, estimating and assessing risks, controlling those risks and monitoring the effectiveness of controls to all phases of the medical device life cycle. Properly performed risk analysis at each stage of device design and implementation will avoid or reduce the chances of significant risks and enhance the safety of the medical device.
Pre-clinical evaluation of a medical device
One of the most important steps in developing a regulatory strategy is planning the pre-clinical evaluation of a medical device. For each medical device, the choice of preclinical testing should be made individually to the specifics of the device, considering its physical, chemical and biological characteristics. As part of the preclinical evaluation of a medical device, the manufacturer should plan activities related to assessing the biocompatibility of the medical device, assessing electrical safety and electromagnetic compatibility, assessing the stability of the device, including shelf life, verifying and validating software, assessing the usability of the device, and specifying requirements and conducting physical, chemical and microbiological tests. In addition, specific requirements will apply to devices with a therapeutic substance, devices manufactured using tissues or cells of human or animal origin, devices consisting of substances or mixtures of substances that are intended for introduction into the human body and are absorbed or locally dispersed in the body, devices containing substances that are carcinogenic, mutagenic or reproductive toxicants or endocrine disruptors, sterile devices, devices with a measuring function or devices combined with another device. Accurately defining the required tests will allow you to meet all requirements and avoid complications during the certification and conformity assessment process of a medical device.
Clinical development strategy of a medical device
Another important step in the regulatory strategy is to determine the clinical development strategy for the device. Based on the intended use of the device, indications for use, contraindications, considering the intended patient and user population of the device, and the risk class of the device, clinical data acquisition activities for the device should be planned. These data can come from clinical trials, but also from evaluation of clinical literature data for an equivalent device, data from review of adverse reaction databases, data from post-market surveillance and post-market clinical observations, and data from the risk management process. The clinical data obtained should be sufficient to demonstrate the safety, efficacy and acceptability of the medical device’s adverse reactions, and a detailed analysis of their availability will allow planning the necessary actions to fill the gaps in case of insufficient data.
Technical documentation
The regulatory strategy should also include the required documentation, which will constitute the set of technical documentation of the device necessary in the conformity assessment of the medical device. According to the MDR Regulation, the technical documentation for a medical device should include a description and specification of the device, a description of previous generations of the device, information provided by the manufacturer (instructions for use, label), design and manufacturing information, general safety and performance requirements, risk management documentation, studies supporting product verification and validation, and post-market surveillance documentation.
Quality Management System
The regulatory strategy should also not forget to plan to meet the obligations of the medical device manufacturer, which include implementing a quality management system in the organization, appointing a person responsible for regulatory compliance and implementing a UDI labeling system.
The quality management system should be implemented as early as the design stage of the medical device, and the design stages documented according to its requirements. The assumptions that the QMS should meet should be in accordance with the MDR Regulation and ISO 13485. The requirements of the system include supervision of documentation, management responsibility, provision of resources, infrastructure and work environment, planning of product realization, customer-related processes, planning of design and development, purchasing, production and service delivery, supervision of monitoring and measurement equipment and nonconforming product, data analysis, and monitoring, measurement and improvement of the QMS. The implementation of a QMS is mandatory for medical device manufacturers, and its scope is individually selected according to the organization’s processes and procedures.
Planning of a certification
The culmination of the regulatory strategy is the planning of certification activities, in the case of devices for which the Notified Body is involved in the conformity assessment, and registration activities. Early planning of how the product will be commercialized, defining the sales model, target markets or reimbursement allows the required activities to be clarified at the design stage.
Summary
In summary, a regulatory compliance strategy is a plan for the design of a medical device that considers individual activities that will ultimately lead to compliance with regulatory and normative requirements for medical devices facilitating the process of certification, registration of the medical device and its implementation in the target sales markets. A properly executed strategy identifies and organizes the steps of the project schedule and allows easier estimation and reduction of project duration and costs and ensures the success which is placing a medical device on the market.