The Issue of the Validity Period of the Medical Products Conformity Declaration Requires Bylaw Regulation

11/ 10/ 2017

National standard ISO / IEC 17050-1: 2006 “Conformity Assessment. Supplier Declaration of Conformity. Part 1. General Requirements “established the minimum requirements to the contents of the declaration of conformity, in particular, the declaration must contain information about the period of its validity.

Note that the scope of this standard is general and does not apply specifically to medical products. Analysis of the norms of the current legislation allows us to conclude that its application in the sphere of medical products circulation is voluntary.

At the same time, the branch technical regulations, which in accordance with the Law of Ukraine “On Technical Regulations and the Conformity Assessment” should regulate this issue, provide for no limitation of the validity period of the conformity declaration.

To settle the current situation, and with the aim of equal interpretation of Ukrainian legislation on the requirements for a declaration of medical products conformity in terms of its validity period, lawyers of Legal Alliance Company consider it advisable to introduce changes in technical regulations in the sphere of medical products circulation.

“Legal Alliance has a long-standing experience in the sphere of medical products circulation. Based on our own experience, we believe that the relevant provision can be included in clause 2 of Annex 3 “Procedure for Ensuring the Operation of an Integrated Quality Management System” to the Technical Regulations on Medical Products approved by Resolution No. 753 of the Cabinet of Ministers as of October 2nd, 2013. This will allow for avoiding double interpretation of the rules of law in the field of medical products” said Natalia Spivak, pharmaceutical regulatory associate.

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