MedicalDevicesLegal

EU #MDR extension amendment and #IVDR / # MDR sell-off period removal amendment entered into force now #medicaldevices #invitrodiagnostics #medtech #IVDs #legacydevices #medtech #medicaldevice medicaldeviceslegal.com/2023/03/20/mdr…

Almost there for the EU #MDR extension and #IVDR removal of sell-off period proposal - accelerated procedure started in Parliament, vote on the substance on Thursday! #medicaldevices #medtech #IVD #invitrodiagnostics medicaldeviceslegal.com/2023/02/15/but…

The #MDR proposal for extension - “Can the maker repair what he makes?” #medicaldevices #medtech #IVDR #EUMDR #EUIVDR #invitrodiagnostics medicaldeviceslegal.com/2023/01/15/the…

#MDR and #IVDR outlook for 2023 - time to restore trust in the EU medical devices regulatory system #medicaldevices #invitrodiagnostics #medtech #medicaltechnology #EUMDR #EUIVDR medicaldeviceslegal.com/2023/01/01/mdr…

Analysis of the #EPSCO meeting regarding #MDR extension and the #MDCG 2022-18 position paper bridging measure for the MDR #medtech #medicaldevices #IVDR #invitrodiagnostics #IVDs #EUMDR #EUIVDR medicaldeviceslegal.com/2022/12/11/the…

New #MDCG guidance on authorised representatives and a Dutch competent authority inspection program on authorised representatives kicking off now #medicaldevices #IVDs #MDR #IVDR #invitrodiagnostics #moleculardiagnostics #authorisedrepresentative medicaldeviceslegal.com/2022/11/06/foc…

The 2nd edition of The Enriched #MDR and #IVDR is available now! #EUMDR #EUIVDR #medicaldevices #IVDs #invitrodiagnostics #medtech medicaldeviceslegal.com/2022/10/27/the…

New EU #productliability rules proposed - a first glance of the impact for the #medicaldevices and #invitrodiagnostics industries. #medtech #moleculardiagnostics #IVDs #ivdtesting #CDx medicaldeviceslegal.com/2022/10/02/the…

MDCG 2022-14, a new position paper by the #MDCG in an attempt to remedy the issues of #notifiedbody capacity. #CEmarking #medicaldevices #invitrodiagnostics #medtech #EUMDR #EUIVDR #moleculardiagnostics medicaldeviceslegal.com/2022/08/31/ver…

More on the #BlueGuide 2022: analysis of the new elements in Chapter 2 and what they mean for #medicaldevices and #IVDs under the #MDR and #IVDR #medtech #EUMDR #EUIVDR #moleculardiagnostics #invitrodiagnostics #CEmarking #medicaldevice medicaldeviceslegal.com/2022/08/07/the…

A first look at the new(ish) things for #medicaldevices and #IVDs in the 2022 #BlueGuide #medtech #MDR #IVDR #invitrodiagnostics #moleculardiagnostics #marketsurveillance #placingonthemarket #CEmarking medicaldeviceslegal.com/2022/08/04/the…

Managing the 2024 MDR danger zone - and outlines of a potential solution in MDCG 2022-11 #medicaldevices #EUMDR #medtech #mdcg medicaldeviceslegal.com/2022/06/20/man…

MDCG guidance as pseudo-legislation - a constitutional no-no under the #MDR and #IVDR #medicaldevices #invitrodiagnostics #medtech #MDCG medicaldeviceslegal.com/2022/05/26/mdc…

Happy #IVDR day! The EU IVDR is now applicable - and what does that mean? #moleculardiagnostics #medicaldevices #medtech #cdx #companiondiagnostics #invitrodiagnostics medicaldeviceslegal.com/2022/05/26/hap…

More on the interpretation of the concept of placing on the market #EUMDR #EUIVDR #medicaldevices #CEmarking #medtech #invitrodiagnostics #placingonthemarket medicaldeviceslegal.com/2022/02/18/mor…

Some critical remarks on inconsistencies and new requirements in MDCG 2021-27 guidance Q&A on importers and distributors of#medicaldevices and #invitrodiagnostics #IVDs #CEmarking #medtech #placingonthemarket #EUMDR #EUIVDR medicaldeviceslegal.com/2021/12/28/mdc…

#IVDR amendment proposal moving on up to adoption with Council not touching the Commission's proposed text #invitrodiagnostics #medicaldevices #diagnostics #moleculardiagnostics #EUIVDR #IVDs @genetictesting medicaldeviceslegal.com/2021/12/01/ivd…

Commission makes legislative proposal to manage #IVDR transition #diagnostics #IVDs #invitrodiagnostics #medtech #companiondiagnostics #medicaldevices #EUIVDR #EUMDR medicaldeviceslegal.com/2021/10/15/pro…

Happy #MDR #DoA and #Swixit / no #Turkxit day! #medicaldevices #medtech #switzerland #eumdr medicaldeviceslegal.com/2021/05/26/hap…

The Enriched #MDR and #IVDR book - finally available: the first comprehensively annotated MDR and IVDR book. #medicaldevices #medtech #diagnostics #IVDs medicaldeviceslegal.com/2021/05/24/the…