The Council of the European Union votes in favor of amending the transitional provisions in the MDR and IVDR
The extension of the transitional periods in the MDR and the removal of the “sell-off” deadline in the MDR and the IVDR were approved by the Council of the EU today. The proposed legislative amendment, however, will not enter into force until it is signed by the European Parliament and the Council and published in the Official Journal of the EU.
The European Commission publishes a proposal to amend the transitional provisions foreseen in the Medical Devices Regulation and the In Vitro Diagnostic Medical Device Regulation
Elizabeth Anne Wright and Jessica Lauren Koffel
Read an overview of the proposed amendments to the transitional provisions of the MDR and the IVDR.
Medical devices and IVDs fall outside the scope of the proposed CRA – but for how long?
Elizabeth Anne Wright and Alexander Wenzel
The medical device industry is out of scope of the proposed Cyber Resilience Act
UK Supreme Court rules on whether a product is defective
Edward Turtle, Tracey Bischofberger and Jack Eastwood
Productwise brings you key takeaways from UK Supreme Court case Hastings v Finsbury Orthopaedics