Europe – MDCG 2022-18 : Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate

In accordance with Article 5 of Regulation (EU) 2017/745 on medical devices (MDR),
a device may be placed on the market only if it complies with the requirements of the
MDR. Pursuant to Article 52 MDR, manufacturers shall undertake an assessment of
the conformity of the device in accordance with the applicable conformity assessment
procedures set out in the MDR, prior to placing a device on the market. As part of the
provisions on market surveillance set out in chapter VII, section 3, the MDR lays
down procedures how competent authorities deal with devices that do not comply
with MDR requirements.
In accordance with Article 94 MDR, competent authorities (CA) of the Member States
shall carry out an evaluation if they have reason to believe that a device

  • may present an unacceptable risk to health or safety of patients, users or other
    persons, or to other aspects of the protection of public health, or
  • otherwise does not comply with the requirements of the MDR…