Expertise of medical devices: assessment of quality, efficacy and safety

Where does it all start?

Perhaps surprisingly, data analysis starts at the stage of dossier collection. After all, registration is not only the responsibility of the regulator, it is a joint work of the manufacturer, the representative and the expert body. And at the end of the day, it is a shared commitment to the end user. That is why it is so important to provide the experts with comprehensive evidence of product safety. And these requirements are quietly proven by the items on the registration dossier. Even seemingly optional or superfluous information, in fact, complement the information on MI. And it is in them that the most common errors are detected in the medical device registration. A thorough and comprehensive quality review of a medical device is conducted by a government agency and the manufacturer needs to be fully prepared for this process. 

So, the dossier analysis starts with legally important documents, such as the free sale certificate, licenses and declarations. It is clear that these documents are optional for different countries and may differ in name and form. The most important thing here is that these documents must not contradict each other and must be correctly certified according to the requirements of the current legislation. That is, the data on the trade name, components and manufacturer must reflect exactly the information that you want to declare and see later in the registration certificate.

As we know, the state examination of medical devices consists of several stages of inspection. The initial examination checks the dossier for completeness. But this does not mean that this stage is less important than the others. The completeness of the registration dossier strongly influences the registration timeframe. Moreover, the following stages analyze the remarks of the previous stages and reconcile the provided data. When the dossier goes to laboratory testing, not only the regulatory document is analyzed, as many believe. Experts at this stage see the whole picture, which allows them to identify unreliable data. This is also part of the safety review of medical devices.

Evidence of quality

If we divide the data in the dossier into important and not so important, in our opinion, the most important are the reports. Technical, biological, clinical, validation, stability, analytical sensitivity and specificity, risk analysis and others. The more serious a product is, the more evidence of its safety is required. What does it mean to be more serious? Medical devices are categorized into 4 risk classes. It all depends on the intended use, method of use, degree of invasiveness, processing method, etc. For each class there is a different package of documents and different terms of duration of registration work. And for medical products for in vitro diagnostics (IVD) there are different types of reports. The examination of medical devices itself depends on the seriousness of the product.

In our experience, it is the quality reports that are most often associated with problems in the medical device review process. Because these reports need to be read and understood. And it is these reports that experts will study most thoroughly. For example, a technical test report involves testing a product for compliance with the requirements of a regulatory document. Each MI or technique is unique and has its own functionality, which must be confirmed by technical test data. Such a report may include not only testing of a finished product, but also of a semi-finished product, if applicable. But the examination of medical devices and medical equipment still has its differences. Reports for equipment include additional testing for electrical safety, MRI compatibility, dust and moisture protection, etc. The most common issues in connection with this report are incorrectly specified components and models in the name of the product, incorrect number of the regulatory document or lack of reference to it, incompleteness, lack of data from international or other standards, lack of test results and conclusions, lack of assurance and even doubts about the origin, due to the lack of accreditation marks of the testing body. 

This list of requirements is far from complete. All reports reflecting the safety and quality of medical products have their own requirements for preparation and conditions for conducting them. The information reflected in the list of dossier documents has a general character to the design and type of submission to the expert body, but does not imply disclosure of requirements to the reports themselves. And this is natural, since the manufacturer already knows what safety requirements exist for its type of product. At least, it should know. Analyze the reports for the most common nonconformities together with LCS-kz.