Development of Operational Documentation for a Medical Device

Operational documentation are documents issued by the manufacturer. They reflect the medical device maintenance and use characteristics. It is essential to develop explanatory notes with the features and technical characteristics of the medical device. The user shall receive complete information about the device itself.

The manufacturer discloses the operating features. This includes warranties for use for a certain period. The principles of maintenance and installation of certain devices are described.

Types of Operational Documents

Operating instructions.
User manual.
Instructions for use of a medical device.
Installation manual with explanatory notes.
Description of the operating process.
Form.
Device passport.

Important! For reusable equipment, the operating manual shall be prepared. For single-use equipment, the instruction shall be prepared.

Information that shall be Included in the Operational Documentation

Indications and contraindications for use;
The presence or absence of side effects;
Full name of the manufacturer;
The position of the person who completes and prepares the document;
An official who certifies a document with his/her signature;
The title of the document itself;
Date of compilation;
Manufacturer's seal;
As well as other information necessary for the appropriate use of the medical device.

The Importance of Correct Completion and Preparation of Operational Documentation

The entire package of documents is submitted for review to Roszdravnadzor. The specialists of supervisory authority shall check that the documentation has been correctly filled out and that it is complete. If any discrepancies or violations are identified, the documentation shall be immediately sent for re-registration. After the documents have been revised, they are sent for further review.

Roszdravnadzor is responsible for checking the technical and operational data. We compare the stated data with the data obtained at the output.

Due to the peculiarities of the procedure of execution of operational documents, these activities should be entrusted to professionals. Our MedReg Consulting employees prepare and execute the necessary documents themselves. All forms shall be completed in accordance with the legal requirements. Please be aware that independent collection of documents may result in a refusal to register a medical device or a delay in making a decision. Roszdravnadzor reserves the right to refuse issuing a registration certificate for a medical device based on incorrectly filled and prepared documents.

Our MedReg Consulting company provides qualified assistance to manufacturers of medical equipment. All documents prepared by us will be accepted by the Federal Service. The customer will receive a registration certificate and all the original documents received when going through the registration procedure for a medical device.