Pure Global AI
EU MDR Regulation

Regulation (EU) 2023/607

Amendment to MDR and IVDR transitional provisions
European UnionEuropean CommissionRegistrationEffective March 20, 2023
What this code is

Regulation (EU) 2023/607 is the official EC identifier for “Amendment to MDR and IVDR transitional provisions”. Regulation (EU) 2023/607 is the official identifier EC uses for this instrument.

Instrument
Regulation
Full name
Regulation (EU) 2023/607
Category
Registration
Source links
Authority source
English
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
Readable HTML
3 articles · 1 language version
Direct citations can link to a specific article or section by appending its fragment identifier.
Dates
Published
March 20, 2023
Effective
March 20, 2023
Readable full text

Open a language version

Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.

About this regulation

Amendment to MDR and IVDR transitional provisions

Amending regulation, date of the act 15 March 2023, OJ L 80 publication 20 March 2023. Article 1 deletes the sell-off date from Article 120(3) and (4) MDR and inserts new Article 120(3a) to (3f), which tie the extended transitional periods for class III implantable and class IIb active devices to a notified-body agreement signed before 26 September 2024; Article 2 makes the corresponding IVDR change in Article 110(4); Article 3 provides that the regulation entered into force on the day of OJ publication. Ingested from the EUR-Lex CONVEX HTML expression for CELEX 32023R0607.

Regulation (EU) 2023/607 is the official identifier EC uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.