December 10, 2022

MDCG: new MDCG 2022-18 on legacy devices whose MDD certificate expires before the issuance of an MDR certificate

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In this publication, MDCG 2022-18 details the steps for applying Article 97 to devices whose certificate under the Directive has expired without yet holding an MDR certificate. This is a situation many Spanish manufacturers currently find themselves in due to the lack of capacity of Notified Bodies to carry out conformity assessments

link: mdcg_2022-18_en_1.pdf (europa.eu)