Medical and technical writing
NB! This section is intended for manufacturers who are just going to develop documentation for medical devices, or who need assistance in updating or revising the documentation. If your medical device meets the requirements of European directives, then, probably, all the necessary documentation is already available.
Conformity assessment procedures for medical devices require Technical documentation (Technical file) to be in place. The Technical file contains evidence that the medical device complies with the Essential Requirements set out in Annex 1 to the Technical regulations.
The Technical documentation must be kept by the person responsible for the introduction of the medical device into circulation (the manufacturer or its Authorized Representative in Ukraine) accessible for the competent authorities for at least 5 years (15 years for active implantable devices) after the placement of the last device on the market.
Technical documentation is required for all classes of medical devices (class I, Is, Ir, Im, IIa, IIb, III), all classes of medical devices for in-vitro diagnostics (List A, B, self-testing, “other”), active implantable medical devices.
The documentation is compiled in any format, but must contain sufficient information to demonstrate the conformity of the medical device with the requirements. List of the documents depend on the class of the device and chosen conformity assessment route. The documentation includes, but is not limited to:
- a description of the medical device, including its planned modifications and scope;
- list of applied standards;
- risk management (analysis and minimization);
- description of design, development, production and quality control processes;
- results of tests, design calculations and inspections;
- for medical devices: preclinical assessment results, clinical assessment results;
- for medical devices for in-vitro diagnostics: evaluation of characteristics (analytical and diagnostic sensitivity, analytical and diagnostic specificity, accuracy, repeatability, reproducibility, traceability of nominal values, etc.);
- labeling and instructions for use, if applicable.
Recommendations for Technical documentation are described in Recommendation NB-MED/2.5.1/Rec5 “Technical Documentation” as well as in MedDev guidelines (eg MEDDEV 2.7/1 rev.4 “Clinical evaluation: a guide for manufacturers and notified bodies”) and methodological recommendations of the Ministry of Health of Ukraine.
Since 2007 we are assisting manufacturers of medical devices with our medical and technical writing services, according to the requirements of the national and EU Directives. We are professional, transparent, compliant and highly effective regulatory consultants.
Frequently asked questions:
1. In what language should the Technical Documentation be filled?
The manufacturer usually prepares documentation in the language of his country, and for export to other countries the documentation is translated into English. Conformity assessment bodies and market surveillance bodies of Ukraine have the right to request translation of documentation into Ukrainian, but they often accept documents in English (except for national documents and forms – Application, labeling, instructions for use, checklist of Essential Requirements etc.).
2. In which laboratories are medical devices tested?
In order for test reports to be used as evidence of compliance with the requirements of technical regulations, it is necessary to conduct tests only in laboratories accredited according to the international standard ISO/IEC 17025. The list of Ukrainian accredited laboratories and their areas is published on the website of the National Accreditation Agency of Ukraine ( NAAU).
3. Is it necessary to conduct clinical trials?
In some cases, clinical trials may be required, but for most medical devices with analogues, such studies are not needed. According to MEDDEV 2.7/1 rev. 4, the source of clinical data are:
- clinical studies of the product itself; or
- clinical trials or other studies described in the scientific literature of a similar device for which equivalence can be demonstrated; or
- published and / or unpublished reports of other clinical experience with a similar device for which equivalence can be demonstrated.
4. How long does it take to develop the documentation if we start from zero?
The timing depends on the resources that the manufacturer himself allocates, on the readiness for production of the product, the selected production scheme. The shortest time frame is usually for OBL-OEM scheme, in which the manufacturer completely outsources the production.
The testing period starts from 1.5 months. Many works and tests can be carried out in parallel, however for new production it is important to be consistent, as the results can lead to corrections and changes in the final product. The more complex the medical device, the higher its class, the more time is needed to develop the documentation.
We have the necessary knowledge, experience and skills to develop technical documentation for medical devices. We proactively and professionally organize the process in a short time.
- Analysis of the available documentation, development of a “road map”;
- Determination of the scope of tests, choice of accredited laboratories;
- Development of individual documents such as risk analysis, clinical assessment;
- Timing and process control;
- Filling of a Technical file in accordance with the requirements of the Technical regulations or EU Directives.