Healthcare, Industry News, Regulatory Affairs

Factsheet released by EC: prediction on possible failure of manufacturers in meeting compliance deadlines

European Commission advises a new factsheet for healthcare providers and institutions for healthcare providers and institutions to prepare for possible shortages of some medical devices and IVDs if the manufacturers do not meet compliance deadlines for the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). The factsheet cites several issues pertaining to the scope and requirements of the new Regulations.

Risk reclassification of some devices under the MDR will require additional steps for manufacturers in order to comply MDR requirements;

New risk classifications for IVDs will necessitate Notified Body (NB) oversight for about 85% of such products under the IVDR against about 20% under the current In Vitro Diagnostic Medical Device Directive (IVDD);

Medical devices, IVDs and services available for sale online will require MDR or IVDR compliance in order to remain available in Europe.

This may result in either manufacturers opting to cease production of some devices rather than meet MDR or IVDR requirements, or firms being not be able to obtain new CE Mark certification under the new Regulations in time.

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