In this post, we will delve into the key requirements outlined in Article 61 of EU MDR 2017/745, which pertains to Clinical Evaluation. At QualityMedDev website, we have previously explored various clinical-related topics, including the significance of clinical evaluation requirements, the formulation of a Clinical Evaluation Plan, and the creation of a Summary of Safety and Clinical Performance (SSCP).
Within the realm of MDR certification, Article 61 holds immense significance as it underscores the crucial role of clinical assessment. Now, let us carefully examine all the requirements associated with Article 61 of EU MDR and engage in a detailed discussion on the potential strategies for their effective implementation.
By delving into the intricacies of Article 61, we aim to provide comprehensive insights into the processes and procedures necessary to ensure compliance with clinical evaluation standards mandated by EU MDR. Through a thorough exploration of these requirements, we can enhance our understanding of the pivotal role clinical evaluation plays in the overall certification process.
Clinical Evaluation and GSPR according to Article 61 EU MDR
Within the realm of GSPRs, the first section of Article 61 draws attention to the critical role of clinical data in demonstrating compliance. Manufacturers are mandated to utilize clinical data to substantiate their adherence to specific GSPRs. Moreover, a crucial requirement is that manufacturers provide a sound justification for the level of clinical evidence necessary to establish compliance with the GSPRs.
Now, let us explore the GSPRs that necessitate the use of clinical data to showcase compliance. We will focus on GSPRs 1 to 9, which encompass a range of fundamental requirements that uphold the safety and efficacy of medical devices. By thoroughly examining each GSPR, we will gain valuable insights into the clinical data needed to meet these essential criteria.
Which are the GSPRs the require clinical data to demonstrate compliance? Taking in consideration the GSPR’s 1 to 9:
| GSPR Number | GSPRs | Does it need Clinical Data? |
|---|---|---|
| 1 | Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art. | Yes. This GSPR is related to safety of the device and it would require clinical data to provide evidence of device safety. |
| 2 | The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio. | No Clinical Data is needed in relation to this GSPR. |
| 3 | Manufacturers shall establish, implement, document and maintain a risk management system. Risk management shall be understood as a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating. In carrying out risk management manufacturers shall: (a) Establish and document a risk management plan for each device (b) Identify and analyse the known and foreseeable hazards associated with each device (c) Estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse (d) Eliminate or control the risks referred to in point (c) in accordance with the requirements of Section 4 (e) Evaluate the impact of information from the production phase and, in particular, from the post-market surveillance system, on hazards and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, benefit-risk ratio and risk acceptability (f) Based on the evaluation of the impact of the information referred to in point (e), if necessary, amend control measures in line with the requirements of Section 4 | Theoretically no clinical data would be needed. However it is clear that risk management and clinical data are highly linked one to each other and clinical data would be needed to update risk management documentation once the device is brought to the market. |
| 4 | Risk control measures adopted by manufacturers for the design and manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged state of the art. To reduce risks, Manufacturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable. In selecting the most appropriate solutions, manufacturers shall, in the following order of priority: (a) Eliminate or reduce risks as far as possible through safe design and manufacture (b) Where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated (c) Provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users Manufacturers shall inform users of any residual risks. | Since the GSPR talks about the generally acknowledged state of the art, clinical data would be necessary to ensure the safety of the device once it is compared to the state of the art. |
| 5 | In eliminating or reducing risks related to use error, the manufacturer shall: (a) Reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety) (b) Give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users) | No clinical data would be necessary. This requirement is mainly met through risk management and usability assessment. |
| 6 | The characteristics and performance of a device shall not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer’s instructions. | Generally, clinical data would be required to demonstrate that performance of the devices are reached and achieved throughout the lifetime of the device. |
| 7 | Devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer. | No clinical data would be needed to ensure that safety and performance of the device is maintained during transportation and storage. |
| 8 | All known and foreseeable risks, and any undesirable side-effects, shall be minimised and be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the device during normal conditions of use. | Yes. Benefit risk analysis shall always be supported by clinical data. |
In case no clinical data are deemed necessary for the demonstration of conformity with general safety and performance requirements, article 61 of EU MDR requires the manufacturer to provide adequate justification for this type of exception. The justification shall provide adequate explanation why non-clinical data and testing are deemed sufficient and appropriate to demonstrate compliance with GSPRs.
Requirements of Article 61 for Class III and Class IIb devices
Specific requirements for the clinical evaluation of Class III and Class IIb devices are outlined in Article 61 of the EU MDR. This article addresses the complexity of the clinical evaluation process and provides manufacturers with the option to seek guidance from an expert panel. The purpose of consulting the expert panel is to review the overall clinical development strategy, including proposals for clinical investigation.
The obligations associated with the expert panel are detailed in Article 106 of the EU MDR. Once the expert panel is consulted, the manufacturer must duly consider their views and opinions. This emphasizes the importance of expert input in ensuring a thorough and comprehensive clinical evaluation.
It is crucial to note that Article 61 of EU MDR 2017/745 specifies that clinical investigation is generally required for implantable devices and Class III devices. However, there are exceptions to this requirement. These exceptions apply when the manufacturer has made modifications to a device that is already on the market. In such cases, clinical investigation may be waived if certain conditions are met:
- the device has been designed by modifications of a device already marketed by the same manufacturer;
- the modified device has been demonstrated by the manufacturer to be equivalent to the marketed device, in accordance with Section 3 of Annex XIV and this demonstration has been endorsed by the notified body;
- the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant safety and performance requirements.
These exceptions acknowledge that in certain circumstances, the clinical evaluation of the marketed device can provide adequate evidence of conformity for the modified device. However, it is important for manufacturers to carefully assess and justify the applicability of these exceptions in accordance with the EU MDR regulations.
Overall, Article 61 of EU MDR plays a crucial role in guiding the clinical evaluation process for Class III and Class IIb devices, providing clear requirements and considerations for manufacturers to ensure compliance and safety.
Methodology for Clinical Evaluation
Article 61 of the EU MDR provides clear guidelines regarding the methodology to be employed for the clinical evaluation and assessment of clinical data by manufacturers. This article outlines the essential elements upon which the clinical evaluation should be based.
Firstly, it emphasizes the importance of conducting a critical evaluation of the relevant scientific literature that pertains to the safety and performance of the device. This involves a comprehensive examination of existing research and studies that are directly applicable to the device under evaluation. By carefully analyzing the scientific literature, manufacturers can gain valuable insights into the device’s safety profile and its overall performance.
Additionally, Article 61 highlights the significance of critically evaluating the results derived from all available clinical investigations. This step involves thoroughly scrutinizing the outcomes and findings of any conducted clinical studies pertaining to the device. By assessing the data obtained from these investigations, manufacturers can gather substantial evidence regarding the device’s efficacy, safety, and performance in real-world settings.
Furthermore, the article emphasizes the importance of considering the currently available alternative treatment options that exist for the intended use of the device. This assessment involves examining the landscape of alternative treatment modalities and comparing them to the subject device. By understanding the alternatives, manufacturers can contextualize the device’s role within the broader treatment options and evaluate its potential advantages or unique benefits.
By adhering to the provisions outlined in Article 61, manufacturers can ensure a thorough and comprehensive clinical evaluation process. This meticulous assessment of scientific literature, clinical investigation results, and alternative treatment options empowers manufacturers to gather robust clinical evidence and make informed decisions regarding the safety and performance of their devices. Ultimately, complying with these guidelines contributes to enhancing patient safety and promoting the effectiveness of medical devices within the European market.
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