Healthcare Committee Workshop “Recognition of Results of Conformity Assessment for Medical Devices”

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Recognition procedure means that the audit of the legal manufacturer will not be necessary under initial conformity assessment (CA) procedure and under annual supervision procedures. That could save significant amount of financial resources and significantly accelerate the procedure.




According to Article 45 of the Law of Ukraine “On Technical Regulations and Conformity Assessment”, companies can follow procedure of national CA by recognition of results of CA made in EU; there is an option of recognizing the results of works on the CA by the national designated bodies under its own responsibility on the basis of signed agreements with foreign accredited CA bodies (subject to the same requirements for accreditation), and the national procedure or its part.

Agenda:

  • The possibility of the procedure without audit of the manufacturer in the primary procedure, annual supervisory audits, audit at recertification;
  • Acceleration of conformity assessment procedure;
  • List of the documents required for recognition procedure;
  • Advantages and disadvantages of recognition conformity assessment procedure;
  • Absence of extra expenses on supervisory audits and recertification;
  • Simplification of the procedure for making changes to the certificate;
  • Official position of governmental regulation authority;
  • Features of negotiation with European notified bodies during conformity assessment procedure.

 

 Our key speakers:

  • Nickolay Romaniok, Head of Chamber Working Group on Healthcare Hardware & Medical Devices Manufacturers, Partner, Cratia;
  • Evgenia Andruschenko, Partner, Cratia.