Pathway for the national manufacturer of medical devices to the EU market

Cratia has traditionally become the general sponsor of the 11th Ukrainian Forum of Medical Devices Market Operators. This important annual event provides a platform for manufacturers, suppliers, distributors and importers of medical devices to address all pressing issues and share valuable business experience, especially during martial law.

As part of this event, Maksym Bagreev, managing partner of Cratia, presented the report “Pathway for the national manufacturer of medical devices to the EU market”. Maxim noted that the signing of the ACAA Agreement or becoming EU member state means in the near future the implementation of relevant provisions of the EU acquis into national legislation and the harmonization with EU requirements and practices in the field of medical devices.

Since 2017, the EU has been transitioning to the new MDR and IVDR Regulations, currently the European market is in the second and final stage of the transition. In order to enter the single EU market, a national manufacturer already needs to meet the higher requirements of the new legislation. To achieve compliance with the new EU Regulation 2017/745 on medical devices Maksym presented a “roadmap” which consists of 10 points:

1. Verification of the medical device class in accordance with the MDR;
2. Implementation of a quality management system, including the development or amendment of procedures for post-marketing, risk management, labeling, suppliers, UDI management, regulatory requirements, etc.;
3. Substantial revision of technical documentation regarding the list of standards and conformity of the product, suppliers, risks, post-marketing, clinical evaluation, labeling;
4. Designation of the person (PRRC) responsible for MDR compliance;
5. Registration and implementation of UDI in production;
6. Designation of the Authorized Representative in the EU;
7. Carrying out the conformity assessment procedure;
8. Issue of the EC Declaration of Conformity, affixing of CE mark;
9. Registration in Eudamed;
10. Implementation of administrative procedures and provision of post-marketing.

In conclusion, Maksym noted that in the conditions of martial law, the procedure is more realistic for class I medical devices, since the conformity assessment procedure does not involve an audit of the manufacturer.

Link to the text of the presentation in Ukrainian language.