The conformity assessment body in Ukraine – Improve Medical – continues to explain to the suppliers various current issues of legalization of medical products as part of the program by the Information Services center. We have already commented on the need to certify the declaration of conformity with the seal of the conformity assessment body. We offer a short master class from Tatiana Pazerska, a specialist with 19 years of experience, Director and Chief Auditor of the company.
— Tatiana, what are the peculiarities of storage and provision of technical documents for medical products considering confidentiality of information contained such documents?
— According to Art. 4 of the Law of Ukraine “On Technical Regulations and Conformity Assessment” all confidential information is protected as commercially sensitive information. The appropriate authorities (supervisory or conformity assessment) do not disclose the information without permission of the persons or entities that provided it. Technical regulations also determine that all parties shall ensure confidentiality of information obtained during fulfillment of their tasks.
When conducting conformity assessment according to Annex 3 of the Technical Regulations (Resolution No.753), e.g. it is essential to have the documents for the quality management system (hereinafter, QMS). Although no document specifies the scope of documents to be requested by the conformity assessment body. We understand that part of such documents (technological, design, clinical research protocols, etc.) are confidential. Here there are different options and cases. For medical products of Class III, e.g. when it is necessary to carry out design verification, the first stage (assessment of documents) is carried out through a visit to the manufacturer. Thus, the manufacturer should not provide all documents – the conformity assessment body can check it on the spot.
— What documents regulate approval of preclinical and clinical studies and reports. Can clinical study be certified by a competent doctor with the appropriate scientific degrees?
— Technical regulations define that a technical file should include reports on preclinical and clinical studies. Annex 10 (Technical Regulation on Resolution No.753) states that a clinical assessment report may include clinical data collected by reviewing scientific articles, other literature sources about the manufacturer’s or equivalent products. Clinical evaluation may also include clinical studies.
Clinical studies are conducted in accordance with regulatory documents, the voluntary use of which is considered to be in accordance with the technical regulation. The lists of regulatory documents are approved by the order of the Ministry of Economic Development and Trade of Ukraine (No.663 of 24.06.2015). The only peculiarity is permit for conducting clinical studies in Ukraine should be given by the State Service of Ukraine on Medicines and Drugs Control (the procedure is described in Annex 9 Technical Regulation on Resolution No.753).
If clinical studies have already been carried out by the manufacturer, then upon evaluation of their completeness, the conformity assessment body must take them into consideration. In this case, the clinical report must be signed by the manufacturers, and also may be signed by specialists with the appropriate education and scientific degree, both engaged and working for the enterprise.
The manufacturer determines the need for preclinical studies. The conformity assessment body analyzes the studies. If for a specific medical product biocompatibility studies must be carried out, and no results are available, the conformity assessment body may require evidence of conformity. Such cases were encountered in practice, but only in relation to national manufacturers. Non-resident manufacturers, as a rule, already have many years of experience in conducting conformity assessment, the necessary test base, including preclinical assessments. Therefore, we certainly take their test protocols into consideration.
— Is it mandatory to verify the contractors of the manufacturer of medical products when assessing the QMS?
— According to technical regulations, the conformity assessment body may verify subcontractors and suppliers at own discretion. If products of related suppliers are critically important for production of the assessed medical products, the conformity assessment body may decide on conformity assessment of subcontractors. However, if it turns out that the QMS of contractors has already been evaluated by the authorities, the conformity assessment body may simply take it into account without further verification.
— If several production sites are engaged in the manufacturing process, may the conformity assessment body under its responsibility selectively verify the manufacturer’s sites during the QMS evaluation process?
— The body must verify all sites where the products for supplies to Ukraine are designed and manufactured. For example, it may be the office where the product is designed and the manufacturing workshop itself. However, according to Ukrainian regulatory documents, we may verify selectively the logistics warehouses. The certificate of conformity will indicate the sites that the specialists of the conformity assessment body visited and assessed.
— How many auditors and technical experts should be included in the QMS evaluation commission? Can it consist only of the chief auditor?
— The number of members of the commission is not stipulated by technical regulations. It should ensure impartiality and competence of the assessment. The chief auditor e.g. may be qualified as a technical expert. Although the manufacturer should take into account that the number of audit-days is calculated based on the personnel working at manufacturing site. It means that in case of departure of one auditor he will simply have to stay longer at the enterprise. And it can cause inconvenience to the manufacturer.
— What is the difference in audit-hours of the second stage during assessment of compliance according to Annex 3 and Annex 6 + 8 (Technical Regulation on Resolution No.753)?
— There is no big difference as during conformity assessment according to Annexes 6 + 8, the entire system is verified, except for the design and development stage.