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June Newsletter 2023
EUROPEAN UNION Implementation of Regulation (EU) 2023/1194 on transitional provisions for products without an intended medical purpose | 21 June 2023 The deadlines for Annex XVI products mentioned in Implementing Regulation (EU) 2022/2346 has been extended in the...
May Newsletter 2023
EUROPEAN UNION (EU) Updated guidance on significant changes under MDR | 12 May 2023 The guidance document MDCG 2020-3 Rev.1 is intended to clarify the concept of ‘significant changes in the design and intended purpose’ under Article 120(3c), point (b) MDR. It concerns...
April Newsletter 2023
Germany Database for In vitro diagnostics medical devices notification | 25 April 2023 In Vitro Diagnostic Medical Devices Notifications includes notifications on the first placing of in vitro diagnostics on the market (according to § 25 MPG - Act on Medical Devices)....