EMERGO SUMMARY OF KEY POINTS:

• Most QA/RA survey respondents report only basic familiarity with new medical device and IVD regulations in Europe.
• Larger firms with more QA/RA resources claim more thorough understanding of MDR and IVDR requirements.
• Publishing of MDR and IVDR final versions will likely lead to more companies focusing on what the new regulations will mean for their CE Marking compliance.

Many medical device companies have yet to fully absorb the ramifications of the new European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) for their compliance efforts, according to Emergo’s 2017 Global Medical Device Industry Outlook.

As part of the survey, nearly 1,400 QA/RA professionals were asked what their level of understanding as of January 2017 was regarding the MDR and IVDR. Almost four out of every five respondents reported only a basic understanding of the new regulations and their effects on the CE Marking process; given the years-long implementation process for these massive new regulations, however, more and more European device market participants will familiarize themselves with the requirements as compliance deadlines draw closer.

Closer study of MDR, IVDR needed by most respondents

A majority of QA/RA respondents (55%) claimed a basic understanding of the MDR and IVDR, but that they had yet to closely study the new regulations. Only 21% of firms reported a full understanding of the regulations in their proposed forms as of January 2017.

Fortunately, only four percent of respondents said they knew nothing about the MDR and IVDR, so clearly the new regulations are on most device companies’ radars as of now.

Bigger firms: Quicker studies

When respondents’ replies were analyzed according to company size, Emergo found that firms with 250 or more employees more often reported in-depth knowledge of the MDR and IVDR (about 28% of larger respondents).

As expected, smaller firms with less than 250 employees—and smaller regulatory departments—claimed less familiarity with the Regulations. Indeed, about a quarter of all respondents from these firms indicated little to no knowledge of European regulatory changes.

No surprises: Final MDR, IVDR versions may spur more attention

Since the publication of the Emergo survey in early 2017, it should be emphasized that final versions of the MDR and IVDR have been published in Europe; the Regulations will likely enter into force in May or June 2017.

Now that European legislators have published finalized components of the Regulations, more medical device companies operating in Europe will begin examining the rules more closely and (hopefully) develop more comprehensive compliance plans.

Additional Emergo services and resources for Europe

For more information on Europe’s changing medical device regulatory landscape, see below:

• European CE Marking consulting and support for medical device manufacturers
• ISO 13485 quality management system implementation and support
• Whitepaper: Understanding Europe’s Medical Device Regulations
• Whitepaper: Understanding Europe’s new In Vitro Diagnostic Medical Devices Regulations