Recognition of conformity assessment results

Since 10.02.2016, the Law of Ukraine "On Technical Regulations and Conformity Assessment" came into force. Article 45 of the Law describes the possibility of recognizing the results of conformity assessment conducted in another country. There are several options for recognition, and in relation to each of the options, the Law sets forth the respective conditions.

Since the Technical Regulations for Medical Devices are based on the relevant EU Directives, paragraph 1 of Article 45 of the Law with respect to the same level of compliance meets the requirements:

Technical regulations for medical devices approved by Resolution of the Cabinet of Ministers of Ukraine No. 753 of 02.10.2013

Council Directive 93/42 / EEC of 14 June 1993 concerning medical devices

Technical regulations for medical products for in-vitro diagnostics, approved by Resolution of the Cabinet of Ministers of Ukraine No. 754 of 02.10.2013

Directive 98/79 / EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

Technical regulations for active medical devices that are implanted approved by Resolution of Cabinet of Ministers of Ukraine No. 755 of 02.10.2013

Council Directive of 20 June 1990 on the approximation of active implantable medical devices

The second paragraph of article 45 describes that for the interstate recognition of documents (that is, the recognition of certificates), an international agreement of Ukraine on mutual recognition of works on conformity assessment is necessary. There are no such agreements to date, and mutual recognition of the results with the EU is possible by signing the Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA) in the field of medical devices, which is one of the components of the Association Agreement between Ukraine and the European Union in the long term.

The third paragraph of the article describes the possibility of recognizing the results of works on the conformity assessment by the national designated bodies under its own responsibility, on the basis of signed agreements with foreign accredited conformity assessment bodies (subject to the same requirements for accreditation), and the national procedure or part thereof.

Therefore, to recognize the conformity assessment, the following conditions must be met:

• The Ukrainian designated conformity assessment body has a signed Agreement on the recognition of the results of work with a foreign body;

• The foreign body has proper accreditation;

• The foreign body has an appointment for the relevant Directives;

• The Application and the required package of documents are submitted, the Ukrainian designated body conducts part of the conformity assessment procedure.

According to our information, the Ukrainian national conformity assessment bodies have signed the Agreement on recognition of results with the following notifying bodies:

Recognition of conformity assessment results  | Cratia

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TÜV SÜD Product Service GmbH TÜV Rheinland LGA Products GmbH BSI

 

Recognition of conformity assessment results  | Cratia 4

Recognition of conformity assessment results  | Cratia 5

Recognition of conformity assessment results  | Cratia 6

DEKRA Certification B.V. DQS Medizinprodukte GmbH Intertek Semko AB

Recognition of conformity assessment results  | Cratia 7

Recognition of conformity assessment results  | Cratia 8

 

Nemko AS ELEKTROTECHNICKÝ 
ZKUŠEBNÍ ÚSTAV, s.p.
 

If your CE certificate is issued by one of the above-mentioned notifications bodies, we are ready to offer you a procedure for recognizing the results of conformity assessment, which will facilitate and speed up the initial procedure, annual supervision and expansion of the system (addition of new products). We have the necessary knowledge, experience and skills to carry out all necessary work. We will take the lead and process arrangement; we will help to conduct the procedure in a short time.

We are fluent in English, and if necessary we are ready to communicate with the manufacturer directly.

We provide:

• All necessary consultations regarding the requirements of the Technical Regulations, possible procedures for assessing compliance;

• Professional examination of documentation;

• Filing of technical documentation, filling in the check-list (essential requirements);

• We perform all works for the Application submition and conformity assessment conduction according to the chosen procedure (Modules) on the basis of the Power of Attorney;

• Development of the Declaration of Conformity to the requirements of the Technical Regulations

• Design of a package marking project and instructions (user manuals);

• Transfer of a package of the necessary technical documentation for storage in the Authorized Representative.

We provide preliminary consultations free of charge, call +38 (044) 332-42-94, 221-71-29, or write by e-mail info@cratia.ua, or come to the meeting directly to our office.