EU Regulation Recap: Economic Operators, Reprocessing, CE Marking And Free Movement
A detailed look at the second of 10 chapters of the new EU Medical Devices Regulation, which is pending final adoption. The chapter focuses on the making available and putting devices into service, obligations of economic operators, reprocessing, CE marking and free movement. Part of an ongoing series.
You may also be interested in...
EU Regulation Recap: IVDR Chapter II – Economic Operators, Reprocessing, CE-Marking And Free Movement
In the third article of a series that takes a deep dive into the EU's forthcoming Medical Device and IVD Regulations, Medtech Insight focuses on the second chapter of the IVD regulatory text. This chapter looks at the making available and putting into services of devices, obligations of economic operators, reprocessing, CE-marking and free movement.
With finite resources, the UK’s regulatory agency responsible for health care products is rapidly addressing COVID-19 medtech issues. But shifting its focus will cause delays elsewhere.
Non-CE-marked products on the EU market, virtual notified body audits, free standards and the Commission bid to pause the MDR. March has seen unprecedented developments as COVID-19 has railroaded through the sector decimating regulatory rules and plans.