MedicalDevicesLegal

Erik Vollebregt, lawyer specialised in EU #medicaldevices #mHealth #eHealth #biotech legal and regulatory; partner at @axonlawyers

[MedicalDevicesLegal @MedDevLegal]

EU #MDR extension amendment and #IVDR / # MDR sell-off period removal amendment entered into force now
#medicaldevices #invitrodiagnostics #medtech #IVDs #legacydevices #medtech #medicaldevice https://t.co/8VN8QwJORT

[MedicalDevicesLegal @MedDevLegal]

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 https://t.co/azNHQj3qHF

[MedicalDevicesLegal @MedDevLegal]

The #MDR proposal for extension - “Can the maker repair what he makes?”
#medicaldevices #medtech #IVDR #EUMDR #EUIVDR #invitrodiagnostics https://t.co/Lqbkx0XoPq

[MedicalDevicesLegal @MedDevLegal]

#MDR and #IVDR outlook for 2023 - time to restore trust in the EU medical devices regulatory system
#medicaldevices #invitrodiagnostics #medtech #medicaltechnology #EUMDR #EUIVDR https://t.co/xq70MEAsW7

[MedicalDevicesLegal @MedDevLegal]

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 https://t.co/Jnbne7FcUl

[MedicalDevicesLegal @MedDevLegal]

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 https://t.co/uEr6I9CSwX

[MedicalDevicesLegal @MedDevLegal]

The 2nd edition of The Enriched #MDR and #IVDR is available now!
#EUMDR #EUIVDR #medicaldevices #IVDs #invitrodiagnostics #medtech https://t.co/5odtwNWHZ3

[MedicalDevicesLegal @MedDevLegal]

New EU #productliability rules proposed - a first glance of the impact for the #medicaldevices and #invitrodiagnostics industries.
#medtech #moleculardiagnostics #IVDs #ivdtesting #CDx https://t.co/BUhnYzkEAC

[MedicalDevicesLegal @MedDevLegal]

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 https://t.co/x4Fj4v45fv

[MedicalDevicesLegal @MedDevLegal]

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 https://t.co/5gYnsr4A8P

[MedicalDevicesLegal @MedDevLegal]

A first look at the new(ish) things for #medicaldevices and #IVDs in the 2022 #BlueGuide
#medtech #MDR #IVDR #invitrodiagnostics #moleculardiagnostics #marketsurveillance #placingonthemarket #CEmarking https://t.co/rrohCNV6XN

[MedicalDevicesLegal @MedDevLegal]

Managing the 2024 MDR danger zone - and outlines of a potential solution in MDCG 2022-11
#medicaldevices #EUMDR #medtech #mdcg https://t.co/K4sBpdl3v8

[MedicalDevicesLegal @MedDevLegal]

MDCG guidance as pseudo-legislation - a constitutional no-no under the #MDR and #IVDR

#medicaldevices #invitrodiagnostics #medtech #MDCG https://t.co/PWKJG7pHbM

[MedicalDevicesLegal @MedDevLegal]

Happy #IVDR day! The EU IVDR is now applicable - and what does that mean?
#moleculardiagnostics #medicaldevices #medtech #cdx #companiondiagnostics #invitrodiagnostics https://t.co/NyObrgpuid

[MedicalDevicesLegal @MedDevLegal]

More on the interpretation of the concept of placing on the market
#EUMDR #EUIVDR #medicaldevices #CEmarking #medtech #invitrodiagnostics #placingonthemarket https://t.co/bcVZ8vFGL2

[MedicalDevicesLegal @MedDevLegal]

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 https://t.co/CmuGmVDd88

[MedicalDevicesLegal @MedDevLegal]

#IVDR amendment proposal moving on up to adoption with Council not touching the Commission's proposed text
#invitrodiagnostics #medicaldevices #diagnostics #moleculardiagnostics #EUIVDR #IVDs @genetictesting https://t.co/sAoeJt8u7K

[MedicalDevicesLegal @MedDevLegal]

Commission makes legislative proposal to manage #IVDR transition
#diagnostics #IVDs #invitrodiagnostics #medtech #companiondiagnostics #medicaldevices #EUIVDR #EUMDR https://t.co/AsreGh13vs

[MedicalDevicesLegal @MedDevLegal]

Happy #MDR #DoA and #Swixit / no #Turkxit day!
#medicaldevices #medtech #switzerland #eumdr https://t.co/DqnHLAWtHT

[MedicalDevicesLegal @MedDevLegal]

The Enriched #MDR and #IVDR book - finally available: the first comprehensively annotated MDR and IVDR book.
#medicaldevices #medtech #diagnostics #IVDs https://t.co/XS7E3ViuBJ