What will happen when there is a dispute over which risk class a product falls into under the future Medical Device and IVD Regulations? How does the scrutiny process differ for medical devices and IVDs? Here we detail chapter V of the future regulations, which addresses these and other classification and conformity-assessment issues.
Once the risk class for a product is known and the relevant basic conformity-assessment procedures applied, there are a series of additional requirements that devices must meet under the forthcoming EU Medical Devices Regulation (MDR) and IVD Regulation (IVDR) that become more involved as the risk inherent in a device rises.
Chapter V of the regulations, likely to be adopted in the first quarter of 2017, deals with the scrutiny mechanism for the higher-risk products. This is a mechanism that will allow additional scrutiny by authorities, including the potential for review by an EU-appointed expert panel, of procedures and checks that have already been carried out by the notified body in its review of a product.
And for products that come under the scope of the MDR, there is an additional layer of review that comes before the formal scrutiny mechanism kicks in, involving an expert panel reviewing the clinical evaluation work of both the manufacturer and the notified body (NB).
Chapter V describes these procedures, along with other conformity-related issues. This table analyzes provisions that are common to both the IVDR and the MDR, and then addresses issues specific to medical devices alone or to IVDs alone.
Chapter V summary: scrutiny and conformity assessments
[Editors' note: This is the sixth article in an ongoing series delving into the MDR and IVDR chapter-by-chapter. The first article focused on the scope and definitionsof the two regulations. The second article and third article explored the MDR and IVDR regulations, respectively, on the topics of making devices available and putting them into service, the obligations of economic operators, reprocessing, CE-marking and free movement. The fourth article focused on Notified Bodies under Chapter IV, and the fifth on conformity assessment procedures under Chapter V. Next up is a look at Chapter VI of the regulations, focusing on clinical evaluation and clinical investigations.
From the editors of Clinica