The Medical Device Coordination Group (MDCG) regularly publishes very useful documents that help notified bodies, authorities and manufacturers to correctly interpret and implement the requirements of the MDR.

Im September 2022 wurden 3 Dokumente veröffentlicht, die teilweise auch Hersteller von Medizinprodukten nach MDR betreffen:

• Manual on Borderline and Classification; From September 2022, a new series of the Handbook on Delineation and Classification under Regulation (EU) 2017/745 on medical devices [...] will be published. The previous manual, which was published under Directive 93/42/EC on medical devices [...], will no longer be updated.

• MDCG 2022-15; Concerning in vitro diagnostic medical devices. Guidelines for appropriate monitoring in relation to the transitional provisions under Article 110 of the IVDR in relation to devices certified under the IVDD.

• MDCG 2021-21 rev. 1; Clarification of the "initial certification for this product type" and the corresponding procedures to be followed by notified bodies in relation to the consultation of the expert panel in accordance with Article 48(6) of Regulation (EU) 2017/746.

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