EU Regulation Recap: A Look At Scope And Definitions In New EU Rules
The EU takes a breather over its summer months after an intense period of discussion about the future Medical Device and IVD Regulations. Taking a broad overview of the new regulatory texts, what do we know about the key changes they will bring? This piece looks at the most noteworthy elements of the MDR and IVDR scope and definitions sections. Look for recaps of other sections in the weeks ahead.
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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.