Regulatory

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The regulatory world is constantly evolving and transforming. New regulations, directives, standards, guidelines are continuously subject to revisions or publications. For this reason, Economic Operators are increasingly “stressed” from a documentary point of view.

EUROPE

A typical example is what has been happening in Europe in recent years. On April 5, 2017, the Parliament and the European Council adopted two new Regulations on Medical Devices (MDR 2017/745) and in-Vitro Diagnostic Medical Devices (MDR 2017/746). These entered into force on 25 May 2017 repealing Directives 93/42 / EEC, 90/385 / EEC and 98/79 / EC.

The new rules will only apply after a defined transition period of 3 years after the entry into force of the Medical Devices Regulation (spring 2020) and 5 years after the entry into force of the in-Vitro Diagnostic Medical Devices Regulation ( spring 2022).

These regulations count several changes among which we include the need for greater clinical evidence, rigorous surveillance procedures and post-sales surveillance, the identification of a qualified person or a team responsible for the regulatory (PRRC), the implementation of a system traceability, the extension of the field of application of a Medical Device, a new Classification system for in-Vitro Diagnostic Medical Devices as well as new rules for Medical Devices. 

UNITED STATES

The Food and Drug Administration (FDA) regulates medical devices sold in the United States to ensure their safety and efficacy.

Such devices range from simple hospital clothes to complex programmable pacemakers and robotic surgical systems. The FDA classification database includes over 6,000 types of medical devices regulated by the Center for Medical Devices and Radiological Safety (CDRH).

Depending on the classification of devices and other factors, federal regulations such as the Code of Federal Regulations, Title 21, define the requirements that must be met for the CDRH to approve or reject the sale in the United States. 

Our team offers multiple solutions for customers interested in maintaining and / or obtaining certifications, creating the documentation required by the bodies in collaboration with the customer, who at the same time receives the training necessary for his self-management. Europe, the United States, Canada, China, Korea, Brazil are just a few examples of countries where we have direct experience in the field, having successfully addressed and finalized the proposed projects.    

VISPE Medical Devices Consulting, REGULATORY section, can help you:    

  • Classify the devices and define the “Borderline” products according to the current regulations and directives
  • Perform a feasibility study for obtaining certifications
  • Realize the documentation (TD, TF, STED) or review the existing one to find out the gaps
  • Plan and follow you in any clinical or laboratory tests
  • Define the “Worst-case Devices” for testing and / or validation processes
  • Interact with Notified Bodies, Competent Authorities and / or Analysis and Testing Laboratories
  • Identify and analyze the risks
  • Review and / or make labels and instructions for use
  • Realize, implement and / or maintain the Clinical, Biological and Usability evaluation
  • Define a PMS plan and manage any incidents
  • Carry out, implement and / or maintain clinical investigations as well PMCF studies
  • Take on the role of Safety Officer
  • Register devices internationally
  • Register your establishment
  • Apply for Premarket Notification 510 (k), unless exempt, or Premarket Approval (PMA)
  • Apply for Investigational Device Exemption (IDE) for Clinical Studies
  • Guide you through the labeling requirements
  • Medical devices reporting
  • Implement your UDI system
  • Open new markets

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