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EC Admits Potential Medical Device and IVD Supply Problems

ISO 13485 MDSAP

The European Commission (EC)  at last admits potential Medical Device and IVD supply problems in coming years starting May 2020

Despite recent flat denials of problems with Notified Body designation and the medical device industry crying for help or some relief versus the May 2020 deadline for MDR, the European Commission has admitted the potential for supply difficulties in a document.

Published  on 17-Jun-19, the document is entitled Factsheet for healthcare professionals and health institutions.  Not a title that would attract the immediate attention of medical device and IVD manufacturers.

The factsheet advises the healthcare sector to prepare for possible shortages of some medical devices and IVDs in the event that manufacturers do not meet compliance deadlines for the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR).

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Possible Causes of Medical Device Shortage 

  • Risk reclassification of some devices under the MDR will require additional steps for manufacturers in order to comply;
  • New risk classifications for IVDs will necessitate Notified Body (NB) oversight for about 85% of such products under the IVDR versus 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.

And with just 2 Notified Bodies designated so far for the entire EU, and they forbidden to take applications under the new Regulations until they are so designated (and we won't even think about how restricted the scope of such designation might be), supply problems look like a 'racing certainty'. 

This Factsheet is well written and gives a comprehensive overview of the myriad issues facing Medical Device/IVD manufacturers. Great place to start for the uninitiated.

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Written by Dr John FitzGerald

Director & Founder of deGRANDSON Global. He spent 15 years in the manufacturing industry and 25 years training, consulting & auditing management systems

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