Improve Medical: How to avoid termination of the certificate of conformity during legalization of medical devices in Ukraine

In the previous publication the cost of the conformity assessment procedure of medical devices with the Technical Regulations and the audit time are determined. One of the consequences of incorrect application of international standards in this field is termination of the certificate of conformity and, accordingly, supplies of medical devices to Ukraine. Tatyana Pazerskaya, Director, Chief Auditor with 20 years of experience of the conformity assessment body Improve Medical, explains in more detail the pitfalls and reasons for termination of the certificate:
Since the beginning of 2018, the market surveillance authorities and law enforcement agencies have enhanced audits of the conformity and medical devices assessment bodies. The consequence of such verifications may be termination of the certificate of conformity of medical devices with the Technical Regulations. Accordingly, it means at least a temporary ban on introduction of products into turnover in Ukraine.
Art. 37 of the Law of Ukraine “On Technical Regulations and Conformity Assessment” sets forth the reasons for suspension of conformity assessment activities in terms of limiting the scope of designation, temporary suspension and cancellation of the decision on designation. And accordingly – of the issued certificate of conformity. The reason may be the appropriate submission of the National Accreditation Agency (hereinafter referred to as the National Agency) to the Ministry of Economic Development (designates the conformity assessment body) if the National Agency during the audit of the conformity assessment body revealed inconsistencies in its activities. The Ministry of Economic Development may limit the scope of designation of the conformity assessment body or cancel the decision on designation entirely.
In one of the latest publications I told about a specific case when it is possible to terminate accreditation of the conformity assessment body. Let me remind that we are talking about the correctness of calculation of cost and audit time during conformity assessment. Failure to comply with these parameters constitutes a violation of Ukrainian legislation and international standards and may result in termination of the certificate of conformity during the audit of the unfair conformity assessment body.
However, it is not the only reason for termination of the certificate and, accordingly, supplies of medical devices. I will tell you more about what actions you should pay attention to during conformity assessment of medical devices.
The National Agency’s website contains the following list of gross violations committed by the conformity assessment bodies which are grounds for canceling their accreditation inter alia:
– the document on conformity of the object of assessment was issued without conducting the conformity assessment procedures according to the specified requirements;
– the facts of falsification of the results of conformity assessment conducted by the accredited conformity assessment body were established;
– there is no possibility to reproduce records on the results of conformity assessment works.
I would pay your attention to the fact that when using the audit procedure of the quality management system, the conformity assessment body should always sign the agreement with the owner of the certified system rather than with its authorized representative in Ukraine (AR). Unfortunately, there are cases when in applying this procedure the bodies sign agreement with the authorized representative. It means that the manufacturer did not actually undertake any obligations to support the system when selling products in Ukraine. Thus, it may dump responsibility at any time.
In all other cases – during other conformity assessment procedures – under the responsibility of the manufacturer, the agent in the person of authorized representative on behalf of and under the responsibility of the system owner has the right to sign the agreement with the conformity assessment body.
For this purpose it is necessary to ensure legality of the activities of the authorized representative in Ukraine. The main document is the agreement on such powers between the manufacturer and its AR. It is a mandatory attribute, because, according to the law, in the process of market supervision public agencies impose sanctions or other restrictive measures on non-resident producers exactly through their AR. It is not enough to execute a general power of attorney to conduct any work by an authorized representative on behalf of the manufacturer. Unfortunately, we still often encounter cases of incorrect legal registration of relations between the manufacturer and the AR.
NB: the requirements to such agreements are also specified in international standards – the IAF MD guidelines.
To comply with all standards during assessing compliance of medical devices with the Technical Regulations, you should also pay attention to the following important peculiarities:
– the conformity assessment bodies must necessarily conduct annual supervisory audits (in case of choosing the conformity assessment procedure by means of QMS audit the certificate is issued for 5 years, with system certification for 3 years). If the conformity assessment body makes a decision (meeting the client’s needs) not to go to such audit, it constitutes a gross violation, which may result in termination of the certificate. During a supervisory audit the inspection is carried out selectively; the QMS is not checked for 100%;
– for sterile products, conformity assessment of the batch without the QMS audit is impossible;
– the conformity assessment body necessarily coordinates the audit program with the manufacturer. It means that the manufacturer coordinates inter alia composition of the commission of the conformity assessment body and, thus, assumes responsibility for its composition. It is important because international standards also impose strict requirements on the competence and qualification of auditors.
– it is necessary to take into account what units or production sites should be verified during the certification audit. I will repeat this thesis from the last publication. Sometimes we hear that some conformity assessment bodies are ready to visit only one of the sites. It may be a serious violation and lead to the same consequences – termination of the certificate. The conformity assessment body must verify the office where, e.g. product design is made and all production sites. However, according to Ukrainian regulatory documents, we may inspect the logistics warehouses selectively. The certificate of conformity will specify the sites that experts of the conformity assessment body visited and assessed;
– the incorrectly determined class of medical product and, accordingly, the incorrectly chosen conformity assessment procedure may result in termination of the certificate;
The specialists of Improve Medical always remind: you should be very careful when choosing the conformity assessment body and whether it complies with the international standards and Ukrainian legislation when conducting a conformity assessment.
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