European Union - Top Medical Device Alerts

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 However, devices placed on the market before or during the transition periods still in the supply chain must be withdrawn.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 presented. "
Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices This document, hereafter called the Manual, records the agreements reached by the Member State members of the Borderline and Classification Working Group (BCWG) following the exchanges under the Helsinki Procedure under Regulation (EU) 2017/745 on medical devices (the MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR). The aspects concerning the borderline between medical devices and other types of products, also known as the qualification of a product, are generally governed by Article 4, the regulatory status of products of the MDR, and the corresponding Article 3 of the IVDR.
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