Technical Documentation
Once we have mapped the requirements, understood the classification, coordinated expectations with the notified body or an authorized representative in the EU – we can start modifying the technical documentation (Technical File).
In the following article, we present the list of processes/documents required to comply with the EU regulation 2017/745 (MDR) and 2017/746 (IVDR) requirements.
Regulatory Strategy As part of our services, we provide our customers' comprehensive regulatory strategy. We can help you identify the device class, contact the responsible body in Europe (Notified Body), adjust the technical file, quality system, evaluation, and clinical plan.
Clinical Evaluation Is an ongoing process conducted throughout the life cycle of a medical device. According to the EU regulation, you shall specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements.
Clinical Investigation It is a systematic investigation involving one or more human subjects undertaken to assess the safety or performance of a medical device.
Pre-Clinical and Clinical Data According to the REGULATION (EU) 2017/745 Section 6.1 of Annex II, results of tests, such as engineering, laboratory, simulated use, and animal tests, and evaluation of published literature applicable to the device, taking into account its intended purpose, or to similar devices, regarding the pre-clinical safety of the device and its conformity with the specifications.
Benefit-Risk Analysis / Risk Management Your device shall be suitable for its intended purpose. It should be safe, effective and not compromise the clinical condition or the safety of the patient. Therefore you should maintain a risk management system.
Product Verification & Validation They are used together to check that a product, service, or system meets requirements and specifications and fulfills its intended purpose.
Post-Market Clinical Follow-Up (PMCF) It is a continuous process that specifies the methods and procedures for proactively collecting and evaluating clinical data. As a manufacturer, you must collect and assess the clinical data from the use in/on the device which bears the CE marking and is laced on the EU market.
Vigilance It is the manufacturer's responsibility to judge each incident on its own and ensure compliance with the statutory reporting requirements contained within the MDR/IVDR.
Declaration of Conformity It is a summary document validating the compliance of a vehicle with the MDR/IVDR. It helps to prove the conformity of your product with the European standards and is registered in the language of the mark of your vehicle.
Quality Management System ISO 13485 is an international quality standard for the medical field, which defines system requirements for quality management in organizations that design, develop, manufacture, sell, install and provide services for products from the medical field and is used to assist, coordinate and synchronize the organizational quality system in front of the medical field.
Person Responsible for Regulatory Compliance (PRRC) According to the European Medical Device Regulation (MDR) - Manufacturers are obligated to have at least one Person Responsible for Regulatory Compliance (PRRC) who possesses the requisite expertise in the field of medical devices.
Periodic Safety Update Report (PSUR) It is a pharmacovigilance document intended to evaluate the risk-benefit balance of a medicinal product at defined time points after its authorization. A PSUR assessment can determine if further investigations on a specific issue are needed or if an action is necessary to protect public health.
Basic UDI-DI Is the primary key in the device-related information in the EUDAMED database. Its goal is to connect devices with the same intended purpose, risk class, basic design, and manufacturing characteristics. As a manufacturer, you are responsible for complying with all UDI-related requirements. Still, you can appoint an authorized person such as PRRC to manage everything related to the UDI.
SRN It is a code for instant recognition of every economic operator in the EU. As a manufacturer, you shall use the SRN when applying to a notified body for conformity assessment and accessing Eudamed to fulfill its obligations under Article 29.
General Safety & Performance Requirements (GSPR) To register a medical device in the EU (CE marking), you must comply with these requirements and have sufficient proof, conformity evidence to prove that he complied with GSPR.
Post Marketing Surveillance (PMS) It is the practice of monitoring the safety of the medical device after it has been released on the market.
Claims The labeling, instructions for use on the device shall be prohibited to use text, names, trademarks, pictures, and figurative or other signs that may mislead your device user or patient regarding the device's intended purpose, safety, and performance.
Labeling Is written, printed, or graphic information is appearing on the medical device or its packaging (of each unit or the packaging of multiple medical devices). You have to ensure that your product labels Carry all of the following elements to prevent non-compliance, such as product name, UDI carrier, etc.
Instruction for Use Information provided by you (as the manufacturer) to inform the user of the device's intended purpose and proper use and any precautions to be taken must be provided together with the device.
Harmonized Standards Specify the basic requirements that Medical Devices must fulfill under the EU regulation for medical devices (MDR/IVDR). You need to stay up-to-date about the latest changes in those requirements when entering the EU market with a medical device.
Common Specifications According to the MDR regulation, the Commission is allowed to adopt typical technical specifications for specific categories. In areas where no harmonized standards exist or where they are insufficient, the Commission should be empowered to lay down common specifications which provide a means of complying with the general safety and performance requirements.
Conformity Assessment Refers to any activity that determines whether a device, system, service, and sometimes people fulfill the requirements and characteristics described in a standard or specification.
How can we assist you?
Our experience has gained extensive expertise in implementing the CE and standards according to lead your products and company all the way and opening the European market for you.
We offer a variety of services designed to accompany and support medical device manufacturers in Israel throughout all the stages listed above, to enable you a smooth and convenient transition that will meet the requirements of the EU Regulation under European Medical Device Regulation and the In Vitro Diagnostic Regulation (MDR/IVDR).
In addition, we will be happy to provide you with a comprehensive professional assistant on other quality and regulatory issues related to medical device services such as the PRRC, with all for the benefit of the organization's compliance with the EU regulatory guidelines.