New country on European regulatory affairs map ll
15 July 2020
This is the second blog written by Nickolay Romanok. Today we continue with the guidance documents and references of regulations, the advantages, the road map, the features and the conclusion regarding Ukraine as new country on regulatory affairs map.
Guidance documents and references of regulations
The below mentioned legal acts and laws define the legal and organisational basis for the development, adoption, and application of technical regulations and the procedures for conformity assessment providing, as well as the implementation of voluntary conformity assessment:
- Law of Ukraine «On technical regulations and conformity assessment
- Technical regulations for medical devices, Decree of the CMU 753
- Technical regulations for Invitro diagnostic, Decree of the CMU 754
- Technical regulations for implantable medical devices, Decree of the CMU 755
- Law of Ukraine, On the General Safety of Non-Food Products
- Law of Ukraine, On Accreditation of Conformity Assessment Bodies
The general requirements for conformity assessment procedures that extracted from the mentioned laws can clarify in few sentences.
- Significant savings in time and money during the initial conformity assessment procedure, including due to the absence of expenses for flights and accommodation;
- Cost savings in supervisory audits, expanding the scope and making changes, recertification procedures;
- Reduction of risks associated with the examination of the quality management system and audit procedure;
- There is no need of confidential documents (such as project documentation) during the design examination process;
- A simpler conformity assessment procedure for medical devices that contain drug or biological components.
- The recognition procedure is carried out on the basis of the document of conformity issued by the notified body, therefore the validity period of the Ukrainian certificate of conformity obtained by recognition cannot exceed the validity period of the recognised CE certificate;
- The scope of the Ukrainian certificate of conformity should be identical to the CE certificate. Thus, during the procedure by recognition it is impossible to add products that are not included in the CE Certificate;
- May be needed to pay for the services of a notified EU body that issued a CE certificate for confirming the scope and validity;
Nevertheless, it is worth remembering that the Ukrainian conformity assessment body is fully responsible for issuing the certificate. This means that all national product requirements must be fully implemented, and the conformity assessment body is additionally convinced of this.
The following requirements are in the area of responsibility of the manufacturer in Ukraine:
- Scope of rights and obligations of the Authorised Representative, legal aspects of the designation of such a representative;
- Content and execution of the declaration of conformity;
- Completeness of the information on the labeling and in the instructions for use (user manual);
- Implementation of post-marketing activities, tracking side effects, and claims during products use on the Ukrainian market;
- Fulfillment of the terms of the Certification Agreement (rules of the certificate use, obligation to conduct annual surveillance procedures, timely amend the scope of the certificate).
The recognition of the CE certificate is the most efficient way for foreign manufacturers to introduce medical devices on the Ukrainian market. Regulatory affairs specialists can avoid some formal procedures, save time, and budgets. As a result, manufacturers can faster be focusing their efforts on marketing and sales force.
We want to thank Nickolay Romanok for his time and sharing his knowledge with our community regarding regulatory affairs in Ukraine. Do you want to contribute insights about the medical devices industry for the medical devices industry? Share your story with us via email@example.com