Jun 25, 2019

A new factsheet from the European Commission advises healthcare providers and institutions 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).

The EC factsheet cites several issues pertaining to the scope and requirements of the new Regulations that may impact availability of devices over the near term:

  • 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.

Manufacturers may opt to cease production of some devices rather than meet MDR or IVDR requirements, or firms may not be able to obtain new CE Mark certification under the new Regulations in time, resulting in at least temporary supply shortages.

Notified Body capacity challenges

A key, well-documented factor determining if and for how long device shortages will occur will be the capacity of NBs to take on new medical device and IVD clients; recertify existing clients to MDR or IVDR specifications within compliance deadlines; and obtain designation themselves to certify devices according to MDR and IVDR requirements.

Manufacturers face the prospect of fewer NBs to support CE Mark certification, as well. So far UK-based LRQA has confirmed it will cease Notified Body operations in Europe, while only two Notified Bodies—BSI and TÜV Süd—have so far received official designation under the MDR and IVDR, with less than a year before the Regulations come fully into effect.

Faster NB designations urged by industry

Medical device industry trade group MedTech Europe recently issued a seven-point list of critical areas it argues European regulators must address in order to ensure more efficient MDR and IVDR compliance and minimize market disruptions.

First among those seven issues is the need for faster NB designations. MedTech Europe notes that the designation process typically takes around 18 months per NB, and that regulators should reduce some staffing, auditing and notification requirements from that process to speed up NB designations.

Additional European MDR and IVDR resources from Emergo by UL:

  • On-site MDR training for medical device manufacturers
  • European MDR gap assessment and transition strategy
  • European CE Marking strategy for medical devices
  • EU CE Mark consulting for IVD devices
  • Whitepaper: Europe’s Medical Devices Regulation (MDR)
  • Whitepaper: Europe’s In-vitro Medical Devices Regulation