When assessing conformity of products to requirements of technical regulations harmonized with the European directives of the New Approach and the Global Approach, the following conformity assessment modules can be used: B+C, B+D, B+H, B+F and G.
These modules provide for the involvement of a third party (accredited and competent certification authority) to carry out mandatory product certification and, with certain modules, certification of the quality management system.
As a result of carrying out product conformity assessment by Module B, type verification certificate is issued.
Module C – certificate of conformity for serial products for no more than one year.
Module F – certificate of conformity for a specific batch of products with indication of all serial numbers of products of this batch.
Module G – certificate of conformity for single products.
The conformity assessment using modules D or H provides for the availability of a certified quality management system, whether under DSTU ISO 9001:2015 Quality Management Systems. Requirements (ISO 9001:2015, IDT), or under DSTU EN ISO 13485:2018 Medical Devices. Quality Management System. Requirements for Regulatory Purposes (EN ISO 13485: 2016, IDT; ISO 13485:2016, IDT).
When such systems are implemented for the first time, they are certified by the accredited certification body.
The algorithm for determining products subject to mandatory certification should be as follows:
