CE MARKING - EU REGULATION (MDR/IVDR)
Technical File

The technical file stages:

  1. Regulatory Strategy - As part of our services we provide to 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 the clinical plan.
     

  2. 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.
     

  3. Clinical Investigation is a systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a medical device.
     

  4. 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;'
     

  5. Benefit-Risk Analysis / Risk Management - Your device shall be suitable for it intended purpose. It should be safe, affective and not compromise the clinical condition or the safety of the patient. Therefore you should maintain a risk management system.
     

  6. Product Verification & Validation are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose.
     

  7. Post-Market Clinical Follow-Up (PMCF) is a continuous process which specify the methods and procedures for proactively collecting and evaluating clinical data. As a manufacturer you must collect and evaluate the clinical data from the use in/on the device which bears the CE marking and is laced on the EU market. 
     

  8. Vigilance is the manufacturer’s responsibility to judge each incident on its own, and to ensure compliance with the statutory reporting requirements contained within the MDR/IVDR.
     

  9. Declaration of Conformity is a summary document validating the compliance of a vehicle with the MDR/IVDR and it helps to prove the conformity of your vehicle with the European standards and in general is registered in the language of the mark of your vehicle. 
     

  10. 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.
     

  11. 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.
     

  12. Periodic Safety Update Report (PSUR) is a pharmacovigilance document intended to provide an evaluation of 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.
     

  13. 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, essential 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.
     

  14. SRN is a code for instant recognition of every economic operator in the EUAs a manufacturer you shall use the SRN when applying to a notified body for conformity assessment and for accessing Eudamed in order to fulfil its obligations under Article 29.
     

  15. General Safety & Performance Requirements (GSPR) are similar to the Essential Requirements under MDD 93/42/EEC. If you want to register your device in the EU (CE marking) you have to comply with these requirements and should have sufficient proof, conformity evidence to prove that he complied with GSPR.
     

  16. Post Marketing Surveillance (PMS) is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market.
     

  17. Claims - the labelling, 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 to the device's intended purpose, safety and performance.
     

  18. Labeling is a written, printed or graphic information appearing on the medical device or on 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.
     

  19. Instruction for Use information provided by you (as the manufacturer) to inform the user of the device's intended purpose and proper use and of any precautions to be taken, must be provided together with the device.
     

  20. Harmonized Standards specify the basic requirements that Medical Devices must fulfill under the EU regulation for medical device (MDR/IVDR). It is important for you to stay up-to-date about the latest changes in those requirements when entering to the EU market with medical device.
     

  21. Common Specifications - According to the MDR regulation, the Commission is allowed to adopt common 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.
     

  22. Conformity Assessment refers to any activity that determines whether a device, system, service and sometimes people fulfil the requirements and characteristics described in a standard or specification.

How can we help?

For almost 20 years Sync Projects has gained extensive expertise and experience in implementing the CE standard in organizations and companies in Israel, on the way to opening the European market.

We offer a variety of services designed to accompany and support medical device manufacturers in Israel throughout all the steps listed above, to enable you a smooth and convenient transition that will meet the requirements of the new regulations under European Medical Device Regulation (IVDR / MDR).

 

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: consultant for the PRRC in your organization and outsourced PRRC, all for the benefit of the organization's compliance with the new regulatory guidelines.

We Provide close and available guidance to any subject in the shortest time as possible.

We provide full transparency to all interested parties and invite you to visit us at any time.

We have more then 16  years of business experience with

a professional and reliable reputation in the field.

The company's services are performed by a skilled team, in order to provide fast and efficient service to all our customers.

We will be happy to assist with any question and request