Audit of the manufacturer

Conformity assessment route with audit (inspection) is the most common way for certification of high risk classes (Is, IIa, IIb, III) medical devices, medical devices for in-vitro diagnostics from the List A and B, active implantable medical devices.

Ukrainian certificate of conformity is issued for a period up to 5 years and can have a wide scope – covering a large number of different groups of medical devices from one legal manufacturer. 

The Ukrainian certification body performs assessment of the technical documentation for medical devices and during the audit performs assessment of the manufacturer’s quality management system. The audit is carried out at the manufacturer’s location (on-site audit), in some cases at the manufacturer’s own subsidiaries and at critical suppliers.

NB! In some cases, it is possible and rational to replace the audit with an EC certificate recognition procedure.

The certificate of conformity is the subject of annual mandatory supervisory audits, which must be carried out every 12 months. Surveillance audits are significantly shorter and cheaper than initial audits.

How is certification through audit carried out?

A non-resident manufacturer designates an Authorized representative in Ukraine by issuing duly legalized documents.

Before starting the procedure, it is necessary to fill in the technical documentation specified in the chosen Annex to the Technical Regulations. Some of the documents, depending on the requirements of a particular certification body, should be translated into Ukrainian language.

Based on the initial manufacturer’s documentation, national documents should be developed:

• Application for conformity assessment;
• Application for design examination (if applicable); 
• Labeling;
• Instructions for use (user manual);
• Check-list of the Essential Requirements (Annex 1 to the Technical regulations);
• Draft of the Declaration of Conformity;
• Cover letters etc.

The Application, original manufacturer’s documentation and national forms should be submitted to the chosen national certification body. Certification body should sign an Agreement on assessment with the manufacturer or it’s Authorized representative.

Certification body performs assessment of the documents and can issue deficiencies: inquire about missing documentation, corrections etc. 

Certification body provides the manufacturer with the draft of the audit plan that includes locations and length of the audit, and information on the group of auditors. Manufacturer and certification body should agree on all the aspects of the audit and sign the relevant documents. Quite often it is necessary to resolve visa, transport, accommodation and other issues.

The audit follows a previously approved plan. During the audit, documentation is assessed, production facilities are inspected, and personnel are interviewed. The manufacturer must know and understand national Ukrainian requirements (such as language and labeling, interaction with Authorized representative, post-marketing etc.), since the medical device will be released for the Ukrainian market.

Based on the results of the audit, the certification body prepares a protocol, which may contain findings that require elimination. After all the findings are solved, the conformity assessment body and the manufacturer sign a Certification agreement (conditions for using the certificate), and a UA Conformity certificate is issued for up to 5 years.

Manufacturer can issue the UA Declaration of conformity and affix the symbol of conformity on the labeling and in the instructions for use. Medical devices can be manufactured, labeled and placed on the market of Ukraine. 

Authorized representative must keep accessible for the competent authorities the Technical files, national forms, decisions taken by the certification body and copies of the DoC and certificates for at least 5 years after placing the medical devices on the market of Ukraine.  

Maintenance of the certificate

Supervisory audits. The certification body, in accordance with the requirements of ISO/IEC 17021, conducts surveillance audits every 12 months to maintain the certificate. For a supervisory audit, it is not required to submit a full set of documents, however, data on changes (variations) and post-marketing for the last year should be submitted.

A supervisory audit is significantly shorter and cheaper than an initial audit. The costs of surveillance audits are borne by the manufacturer or his Authorized Representative.

It is recommended to start preparing documentation for a supervisory audit 3-4 months in advance. If the surveillance audit is not carried out in a timely manner, then the certification body has the right to terminate the certificate.

Changes.The manufacturer is obliged to inform the conformity assessment body and the Authorized Representative on all changes. The notification should be carried out prior to the entry of the changes into force.

Depending on it’s content there are two types of changes: that either require notification or require assessment. Changes may affect the certificate, declaration of conformity, instruction (user manual), labeling.

All changes to the Technical files must be kept by the Authorized Representative as it’s integral part. 

Post marketing. Technical regulations for medical devices put an obligation on the manufacturer and it’s Authorized representative to inform the competent authorities of Ukraine about incidents and product recalls, take corrective actions and systematically analyze the experience of using medical devices.

Recertification. At the end of the certification cycle, the manufacturer can apply for extension of the validity of the certificate for the next period. For recertification it is required to submit the complete set of documents: updated technical files for products, updated documents of the quality management system. The recertification audit, according to the IAF MD 5 requirements, is about 2/3 of the initial audit.

Most frequently asked questions

1. How long is the audit? What does it depend on?
Answer: the duration of the audit is calculated by the certification body in accordance with international regulatory documents, including IAF MD 5. The duration depends on the number of auditors, the number of personnel and the type of procedure (initial, supervisory, recertification). There are also other factors, such as the need for translation.

On average, an initial audit of a small manufacturer is carried out by 2 auditors within 2-3 days.

2. What language is the audit conducted in? Is a translator required?
Answer: it depends on the auditor’s skills. If the auditor speaks a language (for example, English or German), then the audit can take place entirely in that language, without a translator and/or translation of documentation.

We cooperate with conformity assessment bodies whose auditors speak and conduct audits in several languages ​​(English, German, French, Russian, Polish, Ukrainian). This reduces costs and allows faster and smoother certification.

3. How long are the surveillance audits?
Answer: according to the recommendations of IAF MD 5, a supervisory audit should cover about 1/3 of the initial one. For example, if the initial audit is carried out by 2 auditors within 3 days, then supervision will be carried out by 1 auditors within 2 days.

4. What is the subject of the audit?
Answer: the object of the audit is the quality management system of a legal manufacturer. If the system is branched, that is, it covers several areas, then auditing at several locations may be required (depending on the functions of the areas). At the discretion of the authority, the audit may also include the inspection of contract manufacturers (suppliers and subcontractors). 

We have the necessary knowledge, experience and skills to certify medical devices in Ukraine. We proactively and professionally organize the process in a short time.

We provide:

• consulting on national requirements and certification roadmap;
• a team of regulatory specialists who will guide the project;
• clear and professional communication in Ukrainian, Russian or English;
• individually developed draft documents and forms, legal support for their signing;
• translation of documents at a high medical and technical level;
• development of national documents and filling of the Applications;
• submission of documents and follow-up during the assessment process;
• communication with the certification body on behalf of the manufacturer; 
• proposals for optimizing the costs of flights and accommodation;
• visa support, booking of transport and hotels;
• assistance in responding to the comments of the certification body;
• control of processes and timelines;
• finalization of the UA Declaration of conformity, labeling and instructions after receiving the certificate;
• transfer of the Technical files compliant with the requirements of the national legislation to the manufacturer or it’s Authorized representative.