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Актуални правни теми

On 24 April Regulation (EU) 2020/561 postponed application of the MDR by one year until 26 May 2021

The Parliament and the Council have acted with utmost speed and provided legal certainty during these exceptional circumstances.

Regulation 2020/561 was adopted in less than three weeks.
This quick regulatory support is outstanding, especially in the light of the limited number of notified bodies designated under the MDR and the operational delay of the EUDAMED.

The postponement not only helps authorities, notified bodies and businesses but manufacturers also get more time to renew their existing certificates under the Medical Devices Directive.

To ensure the continuous availability of medical devices vitally important to fight the coronavirus, the Regulation allows national authorities to place certain devices on the market even if conformity assessment procedures have not yet been carried out.

However, the In Vitro Diagnostics Medical Devices Regulation (IVDR) is not affected and is still scheduled to enter into force on 26 May 2022. The life science industry is calling for a similar delay; hopefully the Commission will be cooperative.

Source: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R0561&from=EN