The recognition of the certificate issued by the European notified body is the most transparent, fast and economical way of conformity assessment of foreign manufacturers’ medical devices that have been certified in the EU.
On February 10, 2016, the Law of Ukraine “On Technical Regulations and Conformity Assessment” came into force; its Article 45 describes the possibility of recognizing the results of conformity assessment conducted in another country. The law provides several options:
- “full” interstate mutual recognition of conformity documents, based on the Agreement signed between Ukraine and another state;
- “partial” recognition of the results of conformity assessment carried out by a foreign body with which the Ukrainian conformity assessment body signed the relevant Agreement and conducted part of the national procedure.
The interstate mutual recognition of conformity documents (i. e. the recognition of certificates and declarations) is not conducted with any country in the world now. In the long term, mutual recognition is achievable by signing the Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA) for medical devices, which is one of the components of the Ukraine–European Union Association Agreement.
The Ukrainian designated conformity assessment bodies have the right to recognize the results (protocols, reports) of conformity assessment conducted in another country. However, this requires the fulfillment of a number of conditions, the main of which is the signed Recognition Agreement between the Ukrainian and foreign bodies. Other conditions include as follows:
- the same level of requirements for conformity assessment procedures in Ukraine and the country of recognition;
- the existence of a signed mutual recognition agreement between national accreditation bodies;
- compliance with all national requirements (the appointment of an authorized representative, filling out the checklist of the basic requirements, the necessary information on the labeling and instructions, etc.);
- partial implementation of the Ukrainian national procedure with partial recognition of the results of conformity assessment carried out in the country of recognition.
Thus, the “partial” recognition procedure allows for certification of medical devices in Ukraine by partial recognition of the CE certificate, to avoid conducting audits of manufacturers, significantly speed up, simplify and cheapen the process of conformity assessment of medical devices permitted for use in the EU.
According to our information, the following EU notified bodies signed the Agreements on the recognition of conformity assessment results, which allows for conditional recognition of certificates issued by them:
|0123||TÜV SÜD Product Service GmbH|
|0197||TÜV Rheinland LGA Products GmbH|
|2274||TÜV NORD Polska Sp. z o.o|
|0044||TÜV NORD CERT GmbH|
|0086||BSI Assurance UK Limited|
|0344||DEKRA Certification B.V.|
|0124||DEKRA Certification GmbH|
|0297||DQS Medizinprodukte GmbH|
|0476||Kiwa Cermet Italia S.p.a.|
|1984||Kiwa Belgelendirme Hizmetleri A.Ş.|
|0088||Lloyd’s Register Quality Assurance – LRQA|
|0477||Eurofins product testing Italy S.r.l.|
|0413||Intertek Semko AB|
|0318||Agencia Española de Medicamentos y Productos Sanitarios – AEMPS|
|1014||Elektrotechnický zkušební ústav, s.p. – EZÚ|
|0494||SLG Prüf- und Zertifizierungs GmbH|
|0543||Presafe Denmark A/S|
|1370||Bureau Veritas Italia S.P.A.|
|2195||Szutest Uygunluk Değerlendirme A.Ş.|
|0051||IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.|
|0843||UL INTERNATIONAL (UK) LTD|
|0653||NATIONAL EVALUATION CENTER OF QUALITY & TECHNOLOGY IN HEALTH SA – EKAPTY SA|
|1304||SIQ – Slovenian Institute of Quality and Metrology|
|0483||MDC medical device certification GmbH|
|2460||DNV GL Presafe AS|
If your CE certificate is issued by one of the abovementioned notified 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 (adding new products). We have the necessary expertise, experience and skills to carry out all the necessary work. We will manage and organize the process, and help conduct the procedure in a short time.
- all necessary consultations regarding the requirements of the Technical Regulations, the specific requirements of the procedure for the recognition of conformity assessment results.
- professional expert evaluation of documentation.
- the drafting of technical documentation, filling out a checklist (essential requirements) and other national documents.
- on the basis of the Power of Attorney, we carry out all the works required to submit an application and conducting a recognition procedure at a designated body.
- the drafting of a Declaration of Conformity with the requirements of the Technical Regulations, based on the procedure performed.
- development of packaging labeling and instructions (user manual).
- proving you with the package of the necessary technical documentation for storage by the Authorized Representative.