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What is the procedure of conformity assessment?

The conformity assessment procedure comprises any procedure used to determine that a medical device fulfills the Technical Regulation requirements and standards.

According to TRs, medical device classification (Class I, IIa, IIb, III, List A and B, etc.) defines the conformity assessment procedure. These procedures can include self-declaration, QMS audit, CE Certificate recognition, batch certification, etc.

  • The manufacturer is allowed to self-declare (through the CA mark) a medical device that is classified as the Class I (low-risk) device. However, in the case, if a device has a measuring function or is supplied as a sterile device, a CAB is required.
  • For Class IIa (low- to medium- risk), Class IIb (medium- to high-risk), and Class III (high-risk) devices, a CAB audit is essential to check the quality system. The manufacturer can independently choose an audit to proceed with the CA marking.
  • For Class III devices, a CAB evaluates the design of a medical device by reviewing the technical documentation submitted by the manufacturer and issues the CA mark following the Technical Regulations.
  • Active Implantable Medical Devices (AIMD) are considered as Class III (high-risk) devices. Therefore, they must undergo Full Quality Assurance (examination of the design and post-market surveillance).

The manufacturer is required to submit the technical documentation of a medical device (safety and performance claims) to the CAB. The depth of the technical documentation review conducted by the CAP is entirely dependent upon the classification of the device, as defined by the corresponding Technical Regulation.

In case of QMS audit, the CAB will determine the number of audit days and specific sites that should be inspected only after the complete draft application has been submitted.

Be aware that once the manufacturer has submitted a signed application, it is not allowed to provide the same request to any other CAB.

In Ukraine, the conformity assessment certificate of a medical device is valid for 5 years. Please note that the CAB of Ukraine will conduct annual audits throughout the validity period.

FAQ

s

How to indicate what MD’s are subject to self-declaration?

Comment

According to Technical Regulations on medical devices, class I medical devices, non-sterile and without a measuring functions are subject to self-declaration. In line with the Technical Regulations on medical devices for in vitro diagnostic, all MD’s which don’t fall under the list A and list B classification and are not intended for self-control are subject to self-declaration

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Which act should govern a medical device with a medicinal substance?

Comment

The operation of medicines in Ukraine is covered by the Law of Ukraine «On Medicines». I have already defined in previous videos that MD’s are subject to Technical Regulations and other acts. And the Law of Ukraine «On Medicines» doesn’t cover on medical devices (neither in vitro diagnostic devices, nor active implantable devices).

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I don’t have a conformity assessment certificate according to Technical regulations. Can I place on market a medical device without applying to the CAB to proceed a CAP?

Comment

Yes, you can put your MD into circulation in Ukraine without involving a CAB in one and the only case – your medical device is I class risk (non-sterile and without measuring function).

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Is it possible to obtain a certificate without the on-site audit?

Comment

There are two options to proceed the CAP and to avoid on-site audit of the manufacturer: 1. Recognition of CE Certificate. 2. Proceeding batch certification.

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Do I have to proceed with a CAP in Ukraine if I already have a CE Certificate?

Comment

The existence of CE Certificate doesn’t provide any preferences — Ukrainian legislation requires to proceed the conformity assessment procedure under the Ukrainian TR’s even for those manufacturers that possess a CE Certificate.

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Who is the Authorized representative?

Comment

The essential requirement for the manufacturer which is not the resident of Ukraine, is to appoint the authorized representative.

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What is the procedure of conformity assessment?

Comment

Conformity assessment procedure – any procedure used to determine that prescribed requirements in relevant technical regulations or standards are fulfilled.

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What regulations govern the conformity assessment procedure in Ukraine?

Comment

Since 1 July 2015, it has become
a mandatory requirement that medical devices, must be subject
to the assessment of conformity with the Technical regulations (TR) before being placed on the Ukrainian market.

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Who is entitled to proceed the conformity assessment procedure of medical devices in Ukraine?

Comment

In accordance with the Law of Ukraine
“On Technical Regulations
and Conformity Assessment”,
the conformity assessment procedure
is made by the Conformity Assessment Body, an organization which confirmed its competence, proceeded
the accreditation procedure,
and therefore can perform conformity assessment.

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What steps should I take in order to place a medical device on the Ukrainian market?

Comment

It depends on the class of medical devices you want to place on
the market.
As a general rule,
since July 1st, 2015 all suppliers
of medical devices in Ukraine must follow conformity assessment procedures with technical regulations on medical devices.

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