Extension of the transition periods provided for in the regulations
The Regulation introduces a staggered extension to the transition period of Regulation (EU) 2017/745 on medical devices (MDR) and deletes the "sell-off" deadline in both MDR and IVDR. However, devices placed on the market before or during the transition periods still in the supply chain must be withdrawn.
Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/7
"This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), addresses the classification of in vitro
diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under Annex VIII. This classification guidance also applies to
diagnostic or information society services performed on EU patients or devices put into service through distance sales.
MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 - December 2022
"This guidance applies to medical devices which have been certified under the MDR and
to devices that have been certified under MDD 93/42/EEC or AIMDD 90/385/EEC, except
for devices that have stopped being placed on the EU market before the MDR date of entry
into the application (DoA) (see section 3.1). It does not apply to in vitro diagnostic medical
devices certified under IVDR (EU) 2017/746 or IVDD 98/79/EEC for which
specific guidance is intended. Manufacturers of class I devices do not have to prepare a PSUR; instead, they should prepare a Post-Market Surveillance Report (PMSR) as detailed in Article 85. This guidance, although not covering PMSR, may provide useful suggestions on how information can be
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