Europe – KPMG and RAPS: Medical Device Companies Under-prepared for European MDR

EMERGO SUMMARY OF KEY POINTS:

  • A new medical device industry survey finds many firms still lack a firm understanding of the European Medical Devices Regulation (MDR) and related compliance issues.
  • Device manufacturers cite lack of understanding of the MDR as well as shrinking Notified Body capacity as top challenges ahead of the Regulation’s 2020 enforcement deadline.
  • Survey conductors provide several recommendations for manufacturers to more fully prepare for MDR compliance.

A new medical device industry survey shows that many medical device manufacturers still lack long-term plans for compliance to the European Medical Devices Directive (MDR) with a 2020 deadline looming.

Thsurvey, conducted by KPMG and the Regulator Affairs Professional Society (RAPS) earlier in 2018, queried 220 medical device companies regarding their MDR compliance efforts. Only 21% of respondents reported having a deep understanding and a strategy for dealing with MDR’s impact, while 41% of companies indicated little to no understanding of the Regulation. Clearly, many manufacturers have a lot of preparation work ahead of them before MDR comes into force.