Recognition of EC certificate in Ukraine

Recognition of the EC certificate is one of the routes of conformity assessment of medical devices in Ukraine. Under that route, the Ukrainian conformity assessment body partially accepts (recognizes) the results (protocols, reports) of the European notified body instead of repeating such assessment works.  

The most significant benefit of the “recognition” route is the possibility to avoid initial and annual surveillance on-site audits. Recognition of the results of the EU notified bodies allows certifying CE-marked medical devices in Ukraine in an accelerated, transparent, efficient, and cost-saving way. 

The recognition procedure is not an unconditional exchange of the European certificate for the Ukrainian one. When carrying out this procedure, the Manufacturer and the Authorized Representative must fulfill all the requirements of the Technical Regulations, submit an Application to the national conformity assessment body, which, when conducting assessment has the right to consider the results previously obtained by European colleagues. 

Please read our article “Recognition of the EU certificates for medical devices in Ukraine” (September 2019).

How the recognition procedure is carried out 

The conformity assessment route that was chosen in the EU should be mirrored in Ukraine. The procedure starts with filling in the Technical documentation specified in the relevant  Annex to the UA Technical Regulations. Depending on the requirements of a particular certification body some documents should be translated into the Ukrainian language. 

National documents that have to be prepared: 

• UA Application(s) for certification; 
• UA Labeling; 
• UA Instructions (User Manual); 
• UA Essential requirements checklist (Annex 1 to the Technical regulations); 
• UA Declaration of Conformity (as a draft);
• UA Cover letters, etc. 

Initial Technical documentation of the manufacturer and all national documents and forms, decisions of the UA conformity assessment body – must be stored by the Authorized representative for at least 5 years from the date of placing of such medical device on the market, available for review upon inquiry of the market surveillance authority (State Service of Ukraine on Medicines and Drugs Control). 

Application and Technical documentation should be submitted to the Ukrainian conformity assessment body. Within the assessment process, the UA body has the right to issue deficiency letters and inquire about additional documents. 

Ukrainian conformity assessment body performs the assessment of the submitted documents and inquires protocols, reports and/or specific letters from the European notified body. There can be additional requirements, stipulated in the Agreement between EU and UA bodies that should be supported by the manufacturer or the Authorized representative, such as filling of the specific templates etc. 

Certification Agreement (terms of the certificate use) must be signed directly between the Ukrainian conformity assessment body and the manufacturer.  

The Ukrainian CAB issues protocols and decisions, a Certificate of conformity, and, if applicable, a Design Examination certificate. 

Based on the UA conformity assessment certificate, the Manufacturer or its Authorized Representative can sign the UA Declaration of conformity and affix the UA symbol of conformity to Technical regulations on the labeling of the medical device, import and place medical devices on the market of Ukraine. 

EU Notified bodies that signed Agreements on recognition 

Based on our information, agreements on the recognition of the conformity assessment results have been signed with the following EU notified bodies, that makes possible acceptance/recognition of their results (protocols, reports) in Ukraine: 

Legislative basis of the recognition procedure 

Article 55 of the Association Agreement between Ukraine and the EU stipulates that facilitation of access to existing markets is carried out via cooperation in the sphere of technical regulation, including cooperation between certification authorities. 

On February 10, 2016, the Law of Ukraine “On Technical Regulations and Conformity Assessment” came into force, Article 45 of which contains the description of the possibility of recognizing the results of conformity assessment carried out in another country. The law provides two options for recognition:  

• interstate mutual (bilateral) recognition; 
• recognition of the results between certification bodies on the basis of Agreements.  

As of today, interstate mutual (bilateral) recognition is not carried out by Ukraine with any country in the world. In the long run, Ukraine intends to sign with the European Union the ACAA Agreement (Agreement on Conformity Assessment and Acceptance of Industrial Products), commonly called “commercial visa waiver”, which will be formalized by the protocol to the Association Agreement and will introduce mutual recognition in certain sectors of the economy. 

Recognition of results between certification bodies on the basis of Agreements is the second option defined by the law. There are some prerequisites for this. 

The Ukrainian accreditation authority (National Accreditation Agency, NAAU) is an associated member of the European Co-operation for Accreditation (EA) and a signatory of the bilateral agreement on recognition (EA BLA), a full member of the International Laboratory Accreditation Co-operation (ILAC) (signatory of the Mutual Recognition Agreement, ILAC MRA) and a member of the International Accreditation Forum (IAF) (signatory to the Mutual Recognition Agreement, IAF MLA). 

Ukrainian Technical Regulations No.753 on medical devices, No.754 on medical devices for IVD and No. 755 on active implantable medical devices have been developed on the basis of the relevant EU Directives 93/42/EEC, 98/79/EC and 90/385/EEC. 

To carry out the recognition procedure, several requirements must be met, the main of which is the Agreement on recognition between the Ukrainian and European certification bodies. Also there are some other requirements: 

• compliance with all national requirements (designation of an Authorized Representative in Ukraine, filling of initial technical documentation and national documents and forms); 
• submission of the Application and carrying out conformity assessment in accordance with the Annex (procedure) to the Technical regulation, in which the Ukrainian authorities accept the results (protocols, reports) of the European authorities regarding the works under the procedure; 
• fulfillment of some other specific requirements. 

Therefore, the recognition procedure makes possible certification of the medical devices in Ukraine via partial recognition of European protocols that allows avoiding audit of manufacturers, significantly accelerates, simplifies and reduces costs for the process of national conformity assessment for the medical devices approved for use in the EU.

We have significant knowledge, experience and expertise in the recognition of the EC certificates in Ukraine. We proactively and professionally organize the process within short timeframes.

We provide:

• professional communication in English; 
• team of technical, medical and legal experts that will lead the process; 
• deep and comprehensive consultations regarding the national requirements;
• professional expert examination of the documents;
• individual templates and forms, legal support; 
• high-level medical and technical translations of the documents;
• filling of the Technical files and national documents; 
• submission of the documents and follow-up; 
• assistance and support with any questions and deficiencies; 
• control of the process and timelines; 
• finalization of the DoC, labeling and IFU’s; 
• transfer of documents for storage at Authorized representative.