Clinical evaluation for MD-bg

Clinical evaluation for MD

The main criterion for the possibility of conducting trials in the form of clinical evaluation is the presence of an interchangeable device. The definition of an interchangeable device is given in Article 38 "Medical devices" of the Federal Law of 21.11.2011 No. 323-FZ and is as follows: "medical devices may be recognised as interchangeable if they are comparable in terms of functional purpose, quality and technical characteristics and are capable of replacing each other". At first sight, it would seem that there is nothing difficult in selecting an interchangeable device, but this is not the case. The reason for this is the absence in Russian legislation of any criteria of "comparability" and sufficiency of the claimed characteristics for comparison. This allows Roszdravnadzor experts to interpret the concept of interchangeability in the strictest terms, equating it with "identity". For example, the technical documentation for a device in accordance with Russian law includes many parameters that do not actually affect the clinical effectiveness of the device and should not serve as a limitation of interchangeability. However, due to the absence of any comparison criteria, Roszdravnadzor experts can put the manufacturer in very strict frameworks, requiring similarity of each parameter from the documentation. Another problem is Roszdravnadzor's requirement to use information for interchangeable devices taken strictly from the instructions published on Roszdravnadzor's website. Registration rules change regularly, so registration certificates issued especially before 2017 may not comply with the current legislation, and these devices may not contain the required amount of information in the instructions. Moreover, not all instructions for use are currently published on the Roszdravnadzor website. To solve the above-mentioned problems and not only them, we offer the following range of services: 1. Drawing up a request to Roszdravnadzor to add unpublished instructions for use for potential interchangeable devices to the state register of medical devices and organizations (individual entrepreneurs) engaged in the manufacture of medical devices. 2. Search and selection of interchangeable devices. 3. Drawing up a comparison table of the registered and interchangeable device 4. Preparation of a reasonable justification of interchangeability of devices, in the case of identification of differences in parameters and characteristics 5. Preparation of the Report of comparison of technical characteristics with the laboratory conducting technical trials. 6. Search and selection of full-text publications on clinical application of a medical device or interchangeable device on the territory of the Russian Federation or abroad. 7. Search for a clinical organization according to the profile of clinical trials. 8. Drafting/verification of the act, programme and report of clinical trials.

Related services

More services

services-1

Registration of medical devices

services-1

Clinical Trials

services-1

Quality management systems for medical devices

services-1

Simplified registration

services-1

Checking medical equipment

services-1

Expedited product registration

services-1

Simplified registration

services-1

Checking medical equipment

services-1

Expedited product registration

prem-1
8 years

on the market as a Company

prem-2
802 projects

successfully completed projects

prem-1
223 clients

customers from foreign countries

prem-1
70% clients

foreign clients with AR services

Ready to start
cooperation?

Fill out the form and we will contact you as soon as possible to discuss cooperation