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Transitional provisions for medical devices

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Changes

  • : Updated with information about the extended transitional provisions

The transitional provisions for medical devices are outlined in MDR article 120 and IVDR article 110. There are some adjustments to national conditions in the Regulation on medical devices § 20.

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    The transitional provisions extend the validity of certificates issued by notified bodies and allows medical devices to be placed on the market or put into service for a specified period after the entry into force of MDR and IVDR. The purpose of the transitional provisions is to allow economic operators, notified bodies, Member Staes and the commission to adapt to the changes introduced by MDR and IVDR. The transitional provisions also ensures that the provisions of MDR and IVDR are applied correctly. 

    Extended transitional provisions

    To ensure continued access and suppl of medical devices on the European marked, the transitional provisions have been extended by Regulation (EU) 2022/112, Regulation (EU) 2023/607 and Regulation (EU) 2024/1860. Consolidated versions of MDR and IVDR, incorporating these changes, are available on EUR-lex:

    Transitional provisions for products without an intended medical purpose

    There are specific transitional provisions for products without an intended medical purpose. These are outlined in Regulation (EU) 2022/2346, as amended by Regulation (EU) 2023/1194. Please note that the transitional provisions in MDR may also apply to products without an intended medical purpose.

    The transitional provisions for products without an intended medical purpose applies to situations where the manufacturer intends to perform, or is performing, a clinical investigation, the conformity assessment procedure requires involvement from a notified body, and the product is covered by a certificate in accordance with Directive 93/42/EEC.

    Learn more about Products Without an Intended Medical Purpose.

    EU regulations on medical devices