{"id":2658629,"date":"2023-05-16T16:11:10","date_gmt":"2023-05-16T20:11:10","guid":{"rendered":"https:\/\/wordpress-1016567-4521551.cloudwaysapps.com\/plato-data\/article-61-of-eu-mdr-an-overview\/"},"modified":"2023-05-16T16:11:10","modified_gmt":"2023-05-16T20:11:10","slug":"article-61-of-eu-mdr-an-overview","status":"publish","type":"station","link":"https:\/\/platodata.io\/plato-data\/article-61-of-eu-mdr-an-overview\/","title":{"rendered":"Article 61 of EU MDR: An Overview"},"content":{"rendered":"

This this post we are going to discuss about the main requirements associated to Article 61 of EU MDR 2017\/745, that is related to Clinical Evaluation. We have already been discussing about clinical-related topics within QualityMedDev website, such as clinical evaluation requirements<\/a>, Clinical Evaluation Plan<\/a>, and Summary of Safety and Clinical Performance (SSCP<\/a>). <\/p>\n

Article 61 is one of the most important article with EU MDR 2017\/745<\/a>, given the importance of clinical assessment within the MDR certification process. Let\u2019s now consider all the requirements associated to Article 61 of EU MDR and discuss how these requirements may be implemented. <\/p>\n

Clinical Evaluation and GSPR according to Article 61 EU MDR<\/h2>\n

As we know, Annex I of the EU MDR 2017\/745 is focused on the so-called General Safety and Performance Requirements, for which we have already talked about within QualityMedDev website. The first section of Article 61 states the necessity to use clinical data to demonstrate compliance with specific GSPR. Furthermore, it is requested that the manufacturers properly justify the level of clinical evidence necessary to demonstrate compliance with GSPRs. <\/p>\n

Which are the GSPRs the require clinical data to demonstrate compliance? Taking in consideration the GSPR\u2019s 1 to 9: <\/p>\n

\n\n\n\n\n\n\n\n\n\n\n\n\n
GSPR Number<\/th>\nGSPRs<\/th>\nDoes it need Clinical Data?<\/th>\n<\/tr>\n<\/thead>\n
1<\/td>\nDevices 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. <\/td>\nYes. This GSPR is related to safety of the device and it would require clinical data to provide evidence of device safety. <\/td>\n<\/tr>\n
2<\/td>\nThe 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. <\/td>\nNo Clinical Data is needed in relation to this GSPR. <\/td>\n<\/tr>\n
3<\/td>\nManufacturers 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 <\/td>\n		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. <\/td>\n<\/tr>\n
4<\/td>\nRisk 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. <\/td>\n		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. <\/td>\n<\/tr>\n
5<\/td>\nIn 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) <\/td>\n		No clinical data would be necessary. This requirement is mainly met through risk management and usability assessment. <\/td>\n<\/tr>\n
6<\/td>\nThe 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\u2019s instructions. <\/td>\nGenerally, clinical data would be required to demonstrate that performance of the devices are reached and achieved throughout the lifetime of the device. <\/p>\n

 <\/p>\n<\/td>\n<\/tr>\n

7<\/td>\nDevices 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. <\/td>\nNo clinical data would be needed to ensure that safety and performance of the device is maintained during transportation and storage. <\/td>\n<\/tr>\n
8<\/td>\nAll 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. <\/td>\nYes. Benefit risk analysis shall always be supported by clinical data. <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n

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. <\/p>\n

Requirements of Article 61 for Class III and Class IIb devices<\/h2>\n

Specific requirements have been included within Article 61 of EU MDR for clinical evaluation of Class III and Class IIb devices. Specifically, given the complexity of the clinical evaluation process, the manufacturers have the possibility to consult an expert panel with the aim of reviewing the whole clinical development strategy, including proposal for clinical investigation. <\/p>\n

The requirements associated to the expert panel are reported within Article 106 of EU MDR. Once the expert panel is consulted, its views and opinion must be duly considered by the manufacturer. <\/p>\n

It is important to remind that Article 61 of EU MDR 2017\/745 specifies that in case of implantable devices and class III devices, clinical investigation shall always be performed, expect in the following cases: <\/p>\n