Last July, the State Service of Ukraine on Medicines and Drugs Control (SMDC) announced that the extension period in the manner set out in Regulation (EU) 2023/607 will also apply on its territory, a measure that formalises and makes immediately enforceable in Europe the third transitional period for compliance with MDR (EU) 2017/745.
It will then be possible to market CE-marked MDD Medical Devices in Ukraine on the basis of the timeframe and conditions already well known, i.e:
- Class III and IIb implantable devices can be marketed until 31/12/2027;
- Class IIa and I devices can be marketed until 31/12/2028;
- custom-made implantable class III devices until 26/05/2026;
- MDD and AIMDD certified devices can benefit from the extension if the device certificates have not been withdrawn by Notified Bodies;
- Certificates expired before 20/03/2023 are valid in the following cases:
- If before the deadline the Manufacturer and a Notified Body have signed a contract for conformity assessment of the device;
- Whether a Competent Authority has granted an exemption under Article 59 MDR (EU) 2017/745;
- Whether a Competent Authority has requested the Manufacturer to perform the conformity assessment procedure in accordance with Article 97.
Manufacturers must adapt the organization’s quality management system to fully comply with MDR (EU) 2017/745 by including evidence-based documentation in the application for conformity assessment to be submitted by 26/05/2024 to the Ukrainian Notified Body
Infine, sia per i Dispositivi Medici che per i Dispositivi Medico Diagnostico in Vitro anche in Ucraina è cancellato il periodo di sell-off, ovvero la data finale per l’ulteriore messa a disposizione dei dispositivi già immessi sul mercato prima o durante il termine ultimo del periodo di transizione. I dispositivi immessi sul mercato prima e dopo il 26 maggio 2021, quindi, possono continuare a circolare senza alcuna limitazione di tempo.
Finally, for both Medical Devices and In Vitro Diagnostic Medical Devices also in Ukraine, the sell-off period, i.e., the end date for further making available devices already placed on the market before or during the end of the transition period, is cancelled. Devices placed on the market before and after May 26, 2021, therefore, can continue to circulate without any time limitation.
Recognition of MDR and IVDR certificates in Ukraine
In 2019, amendments were made to Article 45 of the Law “On Technical Regulations and Conformity Assessment,” which allowed EU certificates issued under Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) to be recognized.
Acceptance of MDR and IVDR certificates in Ukraine is carried out according to a conventional recognition procedure, but a number of special features need to be considered, such as changing classes and classification rules, verification of equality of essential safety and general safety and performance requirements, requirements for technical documentation, labelling, post-market requirements, etc.
>>> If you want to market Medical Devices in Ukraine, Thema can assist you with the Strategic-Regulatory Consulting service and can give you support in the registration of products with the State Administration of Ukraine on Medicinal Products.
With the Ukrainian Authorized Representative service Thema plays the role of a regulatory contact person in the territory dealing not only with the application but also with the fulfillment of post-market requirements set by the regulations.
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