1, the new version of the standard to regulations as the main line, to further highlight the importance of regulatory requirements
The new version of the standard gives a deep impression is to further emphasize the status and role of the regulatory requirements in the standard, put forward the medical device organization will be integrated into the quality management system of the regulatory requirements of the three rules, that is, in accordance with applicable regulatory requirements to identify the organization's role, based on these roles to identify the regulatory requirements applicable to the organization's activities, in the organization's quality management system into these applicable regulatory requirements.
The new version of the standard uses the term ? Regulatory Requirements?
2. The new version of the standard is more clear about the scope of application
Compared to the 2003 version of the standard, the new version of the standard in the general provisions of the standard is more clear about the scope of application of the standard, the increase in the medical device applicable to the whole life cycle of the medical device industry chain stages of medical device organizations, and also increase the applicable to the supply side or other external parties, etc. This is conducive to a more effective use of the standard in the medical device industry, and also helps to enhance the quality and safety of medical devices. This is conducive to the promotion and application of the new version of the standard at more levels and in a wider range, to better achieve the goal of the standard.
3, strengthen the risk management requirements
In the new version of the standard ?0.2 clarification of the concept? In the proposed? When using the term ? Risk? When the term is used, the application of the term within the scope of the standard is in relation to the safety or performance requirements of the medical device or the fulfillment of applicable regulatory requirements.
Unlike the 2003 version of the standard, which only proposed risk management requirements in 7.1 Product Realization Process Planning and 7.3.2 Design and Development Inputs, the new version of the standard mentions risk identification and management and control in the purchasing process and external supplier control, the software validation process, training planning, and feedback collection, further expanding the scope of risk management, which will be a new challenge for medical device organizations. This will be a new challenge for medical device organizations.
The new version of the standard strengthens the risk management requirements, not only for the implementation of risk management of the entire life cycle of medical device products and services, but also clarifies the requirements for the implementation of risk management for the process of quality management system, and proposes to ? Apply risk-based methodology to control the appropriate processes required by the quality management system? (4.1.2b of the new version of the standard). This is a significant change from the 2003 version of the standard.
4, an increase in procurement and supply-side control requirements
The new version of the standard on the procurement process and supply-side control requirements are more specific and clear.
Clarified in the supplier evaluation guidelines in four areas, namely, supplier performance, the ability of the supplier to provide the product, the supplier to provide the product on the quality of medical devices, and the risk of medical devices to adapt; clearly should meet the requirements of the procurement of products to monitor the performance, but also as a supplier re-evaluation of the content of the inputs; clarified that the failure to fulfill the requirements of the procurement of the supplier's disposal of the procurement of products should be appropriate and in line with the risk of procurement of products. The supplier is required to meet the risks associated with the product being procured and to comply with regulatory requirements.
At the same time, all of these activities require record-keeping. The new version of the standard adds a new clause on procurement information, "Product specification". Product specification In the procurement product validation process, it adds the requirement for the organization to take action and validate the scope of activities when any changes to the procured product are discovered.
This new version of the standard adds more specific and detailed requirements for purchasing and supplier control, which are actionable.
5, new complaint handling provisions
The new version of the standard will be the 2003 version of the standard? Customer complaints? Term modified to? Complaints? ; and add ?8.2.2 Complaint Handling?
It can be seen that the new version of the standard, ? Complaint handling? Become a quality management system? Monitoring and measurement? process, further emphasizing the importance of complaint handling.
6, increased communication with regulatory agencies and reporting requirements to regulatory agencies
The new version of the standard 5.6.2 management review inputs include? Report to the regulator? and 7.2.3 states that the organization shall communicate with and report to the regulator in accordance with applicable regulatory requirements. and in 8.2.2d) it states that the organization shall communicate with regulators in accordance with applicable regulatory requirements. Identify the need to report information to appropriate regulatory agencies? The title of Standard 8.2.3 is? Reporting to Regulatory Authorities It sets out the requirements for the content of the report and for the establishment of documentation of the procedure and the maintenance of records of the report. This requirement helps medical device organizations to better understand the requirements of the regulation through reporting and communicating with the regulatory authorities, and to better implement the regulation. The new version of the standard is a change that is conducive to the technical support of the standard for the regulation of medical devices as well as the implementation of regulations.
7, strengthened the requirements of post-marketing surveillance
The new version of the standard to further clarify the requirements of post-marketing surveillance, the standard increased the term? The new standard further clarifies the requirements for post-marketing surveillance. The systematic process of collecting and analyzing the experience gained from medical devices already on the market.
8, increased the formation of documents and records requirements
The new version of the standard increased the quality management system documents and records requirements. Quality management system documents in the quality manual, program documents, process operation and control documents and records of the requirements have not been reduced, unlike ISO9001:2015 standard relatively weakened the requirements of the document. The new version of the standard? Formation of documents? Reached 43, keep records requirements reached 50, an increase over the 2003 version of the standard. At the same time, the new increase in the provisions of the document requirements, such as 4.2.3 medical device documentation, 7.3.10 design and development of documentation requirements increased document specific requirements. Increase the document requirements not only reflect the binding role of documents, but also emphasize the organization to implement the quality management system requirements of the control capacity and effectiveness. The role of documents in communicating intent, unifying actions, and realizing value-added is fully utilized.
9, increase the management system requirements related to the process
The new version of the standard has the following process to increase the degree of specific requirements: 4.1.6 software confirmation, 5.6 management review, 6.3 infrastructure, 6.4.2 contamination control, 7.2 customer-related processes, 7.3.2 design and development of the plan , 7.3.3 Inputs to design and development, 7.3.9 Control of design and development changes, 7.4.1 Procurement processes, 7.5.1 Control of production and service provision, 7.5.2 Cleaning of products, 7.5.4 Service activities, 7.5.6 Confirmation of production and service processes, 7.5.7 Dedicated requirements for the confirmation of sterilization processes and aseptic barrier systems, 7.5.11 Product protection, 8.3.3 Response to nonconformities found after delivery.
The new version of the standard adds the following clauses: 4.2.3 Medical Device Documentation, 7.3.8 Design and Development Transition, 7.3.10 Design and Development Documentation, 8.2.2 Complaint Handling, and 8.2.3 Reporting to Regulatory Authorities.
The new clauses play an important role in standardizing the design and development process, improving the effectiveness of design and development, improving the technical requirements for medical devices as well as proactively responding to feedback and handling complaints, and enhancing communication with regulatory agencies to implement the regulation.
10, changes in terminology
The new version of the standard *** there are 19 terms, compared to the 2003 version of the standard of the eight terms have changed significantly. The new version of the standard retains the 2003 version of the standard ? Cautionary notice? ,? Implantable medical devices? The new version of the standard retains the 2003 version of the standard of the? Labeling The labeling of implantable medical devices is not required. Medical devices? Medical devices, medical devices, medical devices, medical devices, medical devices, medical devices, medical devices, medical devices, medical devices sterile medical device? and 5 other terms, and for which? Implantable medical devices The term "implantable medical device," "sterile medical device," and "implantable medical device. Labeling The definitions of these terms have been refined. The definitions of the terms of the 2003 edition have been refined. Customer Complaint Revised the term "customer complaint" to "complaint". Complaints and further refined the definition. Deleted the term "active implantable medical device" from the 2003 standard. Active implantable medical devices and? Active Medical Devices? terms. Thirteen terms have been added to the new edition of the standard, including? Authorized representative Authorized representative, authorized representative, authorized representative, authorized representative, authorized representative, and authorized representative. Clinical evaluation The new standard adds 13 terms, including "authorized representative," "clinical evaluation," "clinical evaluation," "clinical evaluation," "clinical evaluation," "clinical evaluation," and "clinical evaluation. Distributor? Importers? Importers? The Importer Life cycle? Manufacturer? Manufacturer? The manufacturer's name is "MLM". Medical Device Family The medical device family, the medical device family, the medical device family, the medical device family, and the medical device family. Performance evaluation? The following are examples of the types of devices that have been evaluated by the medical device industry Post-market surveillance? Product purchasing Procurement of products? Risks Risk management Risk management Risk Management The risk management system is a system that is designed to minimize the risk of the product being used as a barrier. Aseptic barrier systems. The new version of the standard added terminology is conducive to deepen the consistent understanding and implementation of the standard, but also help all parties to communicate with each other.