Maxim Bagrieiev

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Maxim Bagrieiev

Maxim Volodymyrovych BAGRIEIEV
Managing Partner of the Cratia group of companies

He holds two higher education degrees: one in finance and economics, and another in the technical field of quality, standardization, and certification. He has experience in the registration, safety management, and quality of pharmaceuticals and medical devices since 2006. He is fluent in Ukrainian and English.

Since 2024 – Head of the Medical Devices Working Group of the American Chamber of Commerce in Ukraine

Since 2016 – Author of articles on the regulation of medical devices in Informa Lifescience

From 2009 to 2011 – Reuters correspondent on healthcare regulation in Ukraine

From 2007 to 2011 – Tarius (now Biotechgate) correspondent on healthcare regulation, author of articles on the regulation of pharmaceuticals and medical devices in Ukraine and the CIS region

Author of articles and publications:

Private Label (PL) in the cosmetics market (2024)
Provision of medicines, medical devices, and other humanitarian aid for Ukraine (2024)
Manufacturing of medical devices under a private label (2024)
Metrological verification of medical devices in Ukraine (2023)
Provision of medicines, medical devices, and other humanitarian aid for Ukraine (2023)
Post-market surveillance of medical devices in Ukraine (2021)
Recognition of EU certificates for medical devices in Ukraine (2019)
How Brexit affects the medical devices market in Ukraine (2019)
Classification and special requirements for different types of medical devices and their combinations with pharmaceuticals (2017)
Authorized representative of a foreign medical device manufacturer: who they are and their role (2016)
Overview of current regulatory requirements for medical devices in Ukraine (2016)
New requirements for the introduction of medical devices: compliance with Technical Regulations (2015)
Manufacturing of medical devices in Ukraine (2015)
Labeling of medical devices: accompanying information (2013)
Labeling of pharmaceuticals in Braille: current problems and European experience (July 2009)
Publications on registration, pharmacovigilance, and quality management in Reuters and Tarius (2007-2011)

Speaker, Presenter:

Conformity assessment of medical devices in Ukraine in a nutshell (Healthcare System Recovery Forum in Ukraine, March 2024)
Certification of cosmetic products in the EU (Training event at Beauty Expo, March 2024)
Registration of pharmaceuticals in Ukraine (Training event at Beauty Expo, March 2024)
Major changes in the regulation of cosmetic products in Ukraine: new Technical regulation and transitional period. PIF, CPSR, labeling and notification (Webinar, January 2024)
Authorized representative in Ukraine of medical device manufacturer. Role, functions, obligations. Change of the Authorized Representative (Webinar, December 2023)
Regulation of assistive rehabilitation devices and 3D printing of medical devices. Requirements and challenges for custom-made medical devices (Webinar, December 2023)
Recognition of MDD, IVDD, MDR, and IVDR EC certificates in Ukraine. Impact of extension of MDD-MDR transition period on Ukrainian certificates (Webinar, December 2023)
Certification of cosmetic products in the EU (Forum of AMOMD – Association of Medical Device Market Operators, November 2023)
Conformity assessment of medical devices in Ukraine in a nutshell. Key information for foreign manufacturers (Webinar, November 2023)
Certification of cosmetic products in the EU (Training event at Intercharm, October 2023)
Regulation of disinfectants in Ukraine and the EU (Forum of AMOMD – Association of Medical Device Market Operators, November 2021)
Technical regulation for cosmetic products (Forum of AMOMD – Association of Medical Device Market Operators, November 2021)
Most important regulatory events of 2020 and 2021 (10th Ukrainian Forum of Medical Device Market Operators, May 2020)
Combating grey imports and counterfeits in the medical device market (Webinar, March 2021)
Regulation of disinfectants in Ukraine and the EU (Forum of AMOMD – Association of Medical Device Market Operators, November 2020)
Conformity assessment of medical devices during the corona crisis in Ukraine and the world: recognition, remote audits, solutions for healthcare (Forum of AMOMD – Association of Medical Device Market Operators, June 2020)
Conformity assessment of medical devices: production audit or recognition of EU certificate results (Seminar, March 2020)
Authorized representative in Ukraine. Experience with inspections by market surveillance authorities (Seminar, March 2020)
Requirements for legalization and labeling of food products in Ukraine (Seminar, February 2020)
Conformity assessment of Class I medical devices and in-vitro diagnostic medical devices of the “other” group. Entry into the register of persons responsible for introducing medical devices (Seminar, January 2020)
Labeling of medical devices: Technical regulations, language Law, SI units, and other legislative acts (Seminar, January 2020)
Combating grey imports and counterfeits in the medical device market (Seminar, February 2020)
Formulating technical specifications for public procurement of laboratory equipment (Training event by the Charitable Fund “100% Life”, December 2019)
Incoming product control: what to look for. Market surveillance (Training event by the Charitable Fund “100% Life”, December 2019)
Recognition of EC certificates for medical devices in Ukraine (Webinar, October 2019)
ISO 13485 for importer and distributor (Forum of AMOMD – Association of Medical Device Market Operators, November 2019)
Recognition of EU certificates in Ukraine (Seminar, October 2019)
Impact of the language law on market operators: what businesses need to know (Seminar, June 2019)
Building effective protection against grey imports and counterfeits in the medical device market (Seminar, April 2019)
New EU MDR and IVDR Directives on medical devices and in-vitro diagnostic devices (Seminar, April 2019)
Additional technical regulations for medical devices: RoHS2, RED, 94. Conformity assessment of medical devices subject to their requirements (8th Ukrainian Forum of Medical Device Market Operators, March 2019)
Conformity assessment of medical devices to Technical regulations: radio equipment RED, TR 355, restriction of hazardous substances in electronics (RoHS2, TR 139, regulated measuring instruments TR 94) (February 2019)
Building effective protection against grey imports and counterfeits in the medical device market (Seminar, December 2018)
Conformity assessment of in-vitro diagnostic medical devices, accompanying documentation, and labeling (Training event by WHO – World Health Organization, October 2018)
Post-market and market surveillance, interaction with the Authorized representative of the manufacturer in Ukraine (Training event by WHO – World Health Organization, August 2018)
The Medical Device Regulatory Environment in the Eurasian Economic Union (2nd World Congress on Medical Device Regulation, July 2018)
Technical regulation on the restriction of the use of certain hazardous substances in electrical and electronic equipment. Joint use of Regulations 139 and 94 (Seminar, April 2018)
Technical regulation on the restriction of the use of certain hazardous substances in electrical and electronic equipment (7th Ukrainian Forum of Medical Device Market Operators, March 2018)
Conformity assessment of national medical device production, conformity assessment for OEM-OBL manufacturers (Seminar, November 2017)
Development of technical documentation for medical devices (Seminar, November 2017)
Recognition of EC certificates for medical devices and IVDs in Ukraine (Joint event by “Kratiya” and Baker McKenzie in Düsseldorf, Germany, November 2017)
Recognition of CE certification results in Ukraine (Seminar, September 2017)
Legalization of medical devices from July 2, 2017: end of the transition period, recognition of CE certificates, supervisory audits, and changes to the conformity certificate, market surveillance (Seminar, July 2017)
Practical experience of recognizing conformity assessment results conducted in the EU in Ukraine (Seminar, June 2017)
Conformity assessment of medical devices to Technical regulations: practical experience, recognition of CE certification results, regulation No94 (IMF – International Medical Forum, April 2017)
Conducting conformity assessment to the Technical regulation on regulated measuring instruments (Forum of AMOMD – Association of Medical Device Market Operators, April 2017)
Specifics of conformity assessment for pharmaceutical companies (Seminar, March 2017)
Conformity assessment of national medical device production (Seminar, March 2017)
Conformity assessment of medical devices to Technical regulations (Training event by EBA – European Business Association, February 2017)
Practical experience in conformity assessment of foreign medical devices (Seminar, February 2017)
Conformity assessment of medical devices to Technical regulations (Seminar, February 2017)
Access to the Ukrainian medical devices market: dealing with the new regulatory framework and avoiding common pitfalls (Joint event by “Kratiya” and Baker McKenzie in Düsseldorf, Germany, November 2016)
Myths and realities of medical device conformity assessment (Forum of AMOMD – Association of Medical Device Market Operators, November 2017)
Conformity assessment for various types of products: self-declaration, production audit, batch-by-batch procedure (Seminar, July 2016)
Manufacturer instead of importer: legalization of the manufacturer and transition to OEM production (Seminar, April 2016)
Preparation for conformity assessment of medical devices. Practical experience in conformity assessment of medical devices (Training event by the American Chamber of Commerce in Ukraine, April 2016)
Self-declaration – new opportunities for the safest products (Seminar, March 2016)
Practical experience of on-site audits (Seminar, March 2016)
Conformity assessment of medical devices from A to Z: import (Seminar, March 2016)
Ukraine: conformity assessment of medical devices to national Technical regulations (Seminar, September 2015)
Conformity assessment to Technical regulations (Seminar, July 2015)
Use of national standards (DSTU) for conformity assessment to Technical regulations (Seminar, June 2015)
Medical device manufacturing in Ukraine (Seminar, March 2015)
Use of regulatory documents by manufacturers for conformity assessment to Technical regulations (June 2014)
Conformity assessment to Technical regulations: where to start (Forum of AMOMD – Association of Medical Device Market Operators, April 2014)
Labeling of medical device packaging in Ukraine (Seminar, March 2013)
Ukraine: market requirements for medical, pharmaceutical, nutrition, and cosmetic products (Training event by the French Embassy in Ukraine, October 2012)