Recognition of the results of the work of a European notified body
Ukrainian law allows for the recognition of conformity assessment results conducted by European notified bodies, subject to the existence of relevant agreements. This is an important mechanism for manufacturers who are already certified in the EU and want to introduce their products to the Ukrainian market.
Grounds for recognition of results
Recognition of the results of conformity assessment conducted by European notified bodies is based on:
- The Law of Ukraine “On Technical Regulations and Conformity Assessment” (Article 45)
- Mutual recognition agreements between Ukrainian and European notified bodies
The main points of recognition
Conditions
Recognition is only possible if there is a relevant agreement between the Ukrainian conformity assessment body and the European notified body. This ensures that the results of assessments carried out in the EU are recognized in Ukraine without the need to undergo a full conformity assessment procedure.
Advantages
Recognition significantly reduces the time and cost of the procedure, as most of the processes have already been completed in Europe. Manufacturers receive a Ukrainian certificate based on the European one, which simplifies the introduction of the product to the Ukrainian market.
Restrictions
If there is no mutual recognition agreement between the authorities, certificates from a European notified body cannot be recognized in Ukraine. It will be necessary to undergo a procedure involving an audit of the legal manufacturer.
Procedure
When submitting documents for recognition, the Ukrainian conformity assessment body analyzes the documents provided by the European notified body, including certificates of conformity. A certificate issued in Ukraine will have the same validity period as a European certificate.
"Medical HUB" offers comprehensive support at every stage of the procedure
- Consultations on the preparation of technical documentation
- Appointment and coordination of the authorized representative
- Assistance in selecting a conformity assessment body and communication with it
- Preparation of declarations of conformity and obtaining a certificate