What to watch for in the medical sector
ISO 13485 is a quality management system standard. The product conformity assessment, technical file, risk management, clinical evaluation, labelling, registration and similar requirements needed to place medical devices on the market must be assessed separately according to the legislation of the target market.
One of the basic regulations for medical devices in Ukraine is the Technical Regulation on Medical Devices approved by Cabinet of Ministers Resolution No. 753 dated 2 October 2013. The conformity assessment procedure to be applied may vary according to the classification of the product.
Today it cannot be said that a UkrSEPRO certificate must automatically be obtained for a medical device; which conformity assessment procedure the product is subject to must be determined according to the relevant technical regulation.
In medical device exports to the European Union, the ISO 13485 quality management system can form an important foundation; however, the product’s requirements under the EU Medical Device Regulation (MDR 2017/745) must be assessed separately.
How does the process work?
We plan our services in line with the product’s technical characteristics, the legislation of the target market and our customer’s commercial needs, and provide professional coordination from the start of the process to the end.
Target Market → Regulatory Analysis → Certification → Audit → Conformity → Shipment
